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Boston Scientific launches MRI-safe Resonate devices with HeartLogic diagnostic in U.S.
Boston Scientific (NYSE:BSX) launched today its Resonate implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems with the HeartLogic heart failure diagnostic tool. The devices are approved by the FDA for conditional use in an MRI environment, the company reported. Boston Scientific’s HeartLogic diagnostic warns doctors of worsening heart failure, collecting data from sensors monitoring heart sounds, thoracic impedance, heart rate and activity and respiration rate and volume. The company touted its alert system as the first and only of its kind in an implantable device w...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat Boston Scientific Source Type: news

Boston Scientific & #039;s New Defibrillators Really Are Smarter
A suite of sensors designed to make implantable defibrillators smarter received a boost of support this week in the form of a late-breaking clinical trial presentation at the Heart Failure Society of America's annual scientific meeting in Dallas. New data confirmed that Boston Scientific's HeartLogic Diagnostic, which is slated for commercial release later this year as part of a new line of implantable heart devices, accurately enhanced the ability to classify patients at high or low risk of a future heart failure event. The Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) trial sh...
Source: MDDI - September 20, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Software Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 6, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Did Congress just kill medical device innovation? The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a...
Source: Mass Device - September 6, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Boston Scientific wins FCA whistleblower suit over Cognis CRT-Ds, Teligen ICDs
Boston Scientific (NYSE:BSX) has prevailed in dismissing a whistleblower suit alleging its sales of the Cognis cardiac resynchronization therapy defibrillators and Teligen implantable cardioverter defibrillators between 2008 and 2009 violated various false claims acts, according to court documents released late last week. In the suit, Boston Scientific was accused of defrauding the FDA by not reporting alleged defects in the devices which caused insecure connections between the leads and headers they attached to. The complaint alleged that Boston Scientific was made aware of the issue after launching the devices in Eu...
Source: Mass Device - September 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Legal News Boston Scientific Source Type: news

ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure. The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators to standard-of-care pharmacological therapy, the company said. Biotronik touted it as the largest study of its kind to date. Results indicated a 47% r...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Biotronik Medtronic Source Type: news

Medtronic wins CE Mark for MRI-safe Attain Stability quad CRT leads
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Attain Stability quad magnetic resonance imaging-safe left heart leads designed for cardiac resynchronization therapy defibrillators and pacemakers. The leads feature MRI SureScan technology and are cleared for use with 3 Tesla and 1.5T MRI scans, the Fridley, Minn.-based company said. The leads also feature a side-helix designed to be fixated in veins of various sizes, the company said. Medtronic said it has initiated a limited European launch, with the 1st commercial implants recently performed at Bergen, Norway’s Haukeland U...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news

Biotronik launches Edora HF-T MRI-safe CRT-P, touts as smallest in US
Biotronik said today it launched its Edora HF-T magnetic resonance-conditional quadripolar cardiac resynchronization therapy pacemaker, touting it as the smallest device of its type available in the US. The German medical device company said the Edora HF-T QP has a volume of 15 cc, making it the smallest MR conditional CRT-P available in the US. The device has a lifespan of 10 years and features MRI Autodetect, Closed Loop Stimulation and Biotronik Home Monitoring technology, the company said. “Patient care is a constant journey. It doesn’t end when the patient leaves my office or recovers from a procedure...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Biotronik Source Type: news

BIOTRONIK US Launches Smallest MR Conditional Quadripolar Cardiac Resynchronization Therapy Pacemaker
Edora HF-T QP Completes BIOTRONIK's ProMRI Portfolio LAKE OSWEGO, Ore., Aug. 21, 2017 -- (Healthcare Sales & Marketing Network) -- BIOTRONIK today announced FDA approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) c... Devices, Cardiology, FDA, Product Launch BIOTRONIK, Edora HF-T QP, cardiac resynchronization therapy, pacemaker (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 21, 2017 Category: Pharmaceuticals Source Type: news

Medtronic wins Health Canada approval for MRI-safe line of CRT-Ds
Medtronic (NYSE:MDT) said today its Medtronic Canada subsidiary received Health Canada approval for its line of MRI-conditional cardiac resynchronization therapy defibrillators, touting them as the 1st MRI CRT-Ds cleared in the region. With the new clearance, Fridley, Minn.-based Medtronic’s Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems, which are currently available in the region, are cleared for MRI scans of any part of the body without positioning restrictions. Both newly cleared devices can be paired with the company’s Attain Performa MRI SureScan quadripolar leads, Med...
Source: Mass Device - July 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news

Biotronik wins FDA nod for atrial lead-less Intica ICD line
Biotronik said today it won FDA approval for its Intica DX and Intica cardiac resynchronization therapy CRT-DX implantable cardioverter defibrillator systems and that it launched the devices in the US. The Berlin-based company touted that the Intica line of ICD devices are the 1st to not require an atrial lead, normally used to monitor electrical activity in the atrium, as the system itself provides the necessary atrial signal information. Atrial diagnostics are used for the early detection of supraventricular tachycardia, atrial fibrillation and atrial ventricular synchronization. “When treating heart failure p...
Source: Mass Device - July 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news

Medtronic touts cost, treatment data on CRT devices
Medtronic (NYSE:MDT) today touted data showing that a pair of algorithms improved treatment and lowered costs for patients treated with its cardiac resynchronization therapy devices. The Fridley, Minn.-based medical device giant said its AdaptivCRT and EffectiveCRT algorithms lowered costs and improved therapy delivery in heart failure patients with atrial fibrillation. Results from 1 of 3 analyses presented at the European Heart Rhythm Assn. Europace Cardiostim conference in Vienna this week showed that the AdaptivCRT program cut the lifetime cost of treatment by an average of €1,055 (about $1,174) in 3 Eur...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management Medtronic Source Type: news

Using CRM devices as forensic clues
Pacemakers and other cardiac rhythm management devices could help solve forensic cases by revealing a time and cause of death in cases where an autopsy is inadequate, according to a study presented today at EHRA Europace Cardiostim 2017. Lead author Dr. Philipp Lacour said in a statement that using CRM devices as clues could help satisfy an unmet need – nearly 30% of forensic cases remain unsolved because the autopsy does not clarify the cause or time of death. “The number of implanted cardiac devices with sophisticated diagnostic functions is increasing and we thought interrogating them might help to shed ligh...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Health Information Technology Software / IT Source Type: news

Biotronik wins CE Mark for 3T scans with ProMRI pacers
Biotronik said today it won CE Mark approval in the European Union for 3 Tesla full-body scans with its latest range of MR conditional pacemakers featuring its ProMRI technology. The new clearance covers single and dual chamber pacemakers from the Edora, Evity and Enitra series during ultra-high field MRI scans. The approval makes it possible to scan areas of the body typically off limits to pacemaker patients, Biotronik said. “As 3 T MRI becomes increasingly prevalent in the management of a variety of diseases, it is vital that pacemaker patients also have access to this invaluable mode of imaging. Thoracic ima...
Source: Mass Device - June 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Biotronik Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 10, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Intrinsic Therapeutics raises $50m for Barricaid annular closure device Intrinsic Therapeutics said today that it raised a $49 million debt-and-equity round for the Barricaid annular closure device for discectomies that it&rsqu...
Source: Mass Device - May 10, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic wins 1st FDA approval for MRI-safe quad pacers
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its line of quadripolar, MRI-safe cardiac resynchronization therapy pacemakers. The approval covers Medtronic’s Percepta, Serena and Solara devices, the Fridley, Minn.-based company said. The devices are slated tho hit the U.S. market in “early summer,” Medtronic said. In February the company said it had won CE Mark approval in the European Union for the MRI-safe quad pacer line and planned a March debut. “Developing cardiac devices so physicians have the best treatment options to meet the individual...
Source: Mass Device - May 10, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Imaging Regulatory/Compliance Medtronic Source Type: news

Medtronic First to Receive FDA Approval for MR-Conditional Quadripolar Cardiac Resynchronization Therapy-Pacemakers
Portfolio of Next Generation Heart Failure Devices Offers Effective Pacing and Access to the Most Advanced Diagnostic Imaging Procedures DUBLIN - May 10, 2017 -- (Healthcare Sales & Marketing Network) -- Medtronic plc (NYSE:MDT) has received U.S. Food a... Devices, Cardiology, Radiology, FDA Medtronic, cardiac resynchronization therapy, pacemaker, magnetic resonance (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 10, 2017 Category: Pharmaceuticals Source Type: news

Biotronik wins FDA nod for CRT-D Multi-Pole Pacing tech
Biotronik said today it won FDA approval for its MultiPole Pacing technology designed for its cardiac resynchronization therapy defibrillator systems. The MPP technology is designed to treat the 40% of heart failure patients who are initially non-responsive to CRT by enabling the left ventricle to be paced twice per cardiac cycle, the Berlin, Germany-based company said. “MultiPole Pacing is an important technology that allows physicians to tailor cardiac resynchronization therapy to each patient. Heart failure is a complex condition and physicians are routinely challenged to find the ideal treatment for unique diseas...
Source: Mass Device - May 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 9, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. 10 new crowdfunded health devices that will intrigue you With crowdfunding websites like Kickstarter and Indiegogo, companies can obtain the funding for ideas they want to come to life (even potato salad parties), with the prom...
Source: Mass Device - May 9, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

His-Bundle Pacing for CRT: Has It Finally Hit Critical Mass? His-Bundle Pacing for CRT: Has It Finally Hit Critical Mass?
Will standard biventricular pacing become obsolete for cardiac resynchronization therapy? His-bundle pacing may turn out to be better; it takes fewer leads and lets ventricles contract on their own.Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - April 21, 2017 Category: Cardiology Tags: Cardiology News Source Type: news

FDA warns Abbott on St. Jude Medical plant in California
The FDA yesterday issued another warning letter about a St. Jude Medical (NYSE:STJ) plant in California, now owned by Abbott (NYSE:ABT), that makes cardiac rhythm management products. It’s at least the 2nd time the federal safety watchdog has flagged the plant in Sylmar, which makes defibrillators and the Merlin home cardiac monitor. In 2012 the FDA slapped St. Jude with a warning letter over problems with the manufacture of its Durata defibrillator leads; that letter was closed out in July 2014. Abbott paid $25 million earlier this year to acquire St. Jude. The FDA said inspections at t...
Source: Mass Device - April 13, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Wall Street Beat Abbott Cardiac Rhythm Management st-jude-medical Warning Letter Source Type: news

Abbott launches new double-bend quadripolar LV lead
Abbott (NYSE:ABT) said today it launched a new Quartet quadripolar left ventricular lead designed for cardiac resynchronization therapy pacemakers and defibrillators. The newly launched quadripolar LV lead features a double bend shape which the Abbott Park, Ill.-based company said will aid in patient optimization in combination with its MultiPoint pacing and SyncAV technology, according to a press release. Abbott touted the quadripolar leads, saying the Quartet lead design allows for implantation in the “most stable position” without sacrificing electrical performance. The company said that data from more than ...
Source: Mass Device - April 12, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Abbott Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 4, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Medical Technology Venture Partners raises $20m toward $50m fund Medical Technology Venture Partners reported raising $20 million for its maiden $50 million fund. The San Francisco-based VC shop said in a regulatory filing that...
Source: Mass Device - April 4, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Appeals court upholds Medtronic win in $6m legal fees spat with Mirowski
The estate of Dr. Michel Mirowski, who helped invent the implantable defibrillator owes Medtronic (NYSE:MDT) $6 million to cover legal fees in their long-running patent spat, a federal appeals court ruled today. Mirowski Family Ventures represents the estate of CRM pioneer Dr. Michel Mirowski. The group, which controls several patents related to ICDs and cardiac resynchronization therapy devices, has been pursuing patent infringement cases against Medtronic, Guidant and successor Boston Scientific (NYSE:BSX) for years. The case, which eventually found its way to the U.S. Supreme Court, dates i...
Source: Mass Device - April 4, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Legal News Patent Infringement Boston Scientific Cardiac Rhythm Management Eli Lilly & Co. Guidant Corp. Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 17, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. GlucoMe tackles connected diabetes management with acoustic data transmission The Centers for Disease Control & Prevention predict that by 2050, if current trends continue, 1 in 3 adults in the U.S. will have diabetes. The d...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: News Well Plus 5 Source Type: news

Boston Scientific touts U.K. nod for EnduraLife batteries
Boston Scientific (NYSE:BSX) said yesterday that a U.K. healthcare agency backed its EnduraLife batteries for cardiac resynchronization therapy defibrillators, citing the savings offering by reduced replacement procedures. The guidance from Great Britain’s National Institute for Health & Care Excellence concluded that the EnduraLife technology would improve outcomes and create some $7.4 million (£6 million) in savings over 5 years, Boston Scientific said. The NICE evaluation calculated that avoiding early replacement procedures would pare costs such as hospital admissions, bed days and p...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Wall Street Beat ACC 2017 Boston Scientific Cardiac Rhythm Management Source Type: news

New Analysis of Reverse Trial Shows Medtronic CRT Devices Cost-Effective, While Helping Patients with Mild Heart Failure Live Longer
Medtronic plc (NYSE:MDT) today announced an economic analysis of five-year data showing that patients with mild heart failure who get cardiac resynchronization therapy (CRT) devices early in their treatment live longer and that implanting these devices is cost-effective, compared to optimal medical therapy. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 6, 2017 Category: Cardiology Source Type: news

Medtronic touts 5-year economic analysis data from CRT-focused Reverse study
Medtronic (NYSE:MDT) today released 5-year economic analysis data from its Reverse study of patients treated with cardiac resynchronization therapy devices, touting longer lifespans and long-term cost efficiency compared to optimal medical therapy. Results from the Reverse trial were published in the Journal of the American College of Cardiology: Heart Failure. “These new data expand upon the current evidence and guidelines for the treatment of heart failure, by showing that CRT in patients with mildly symptomatic heart failure is beneficial, both from a clinical perspective, as well as from a financial perspective. ...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for February 24, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. FDA panel supports Claret Medical’s Sentinel, despite efficacy questions The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection dev...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: News Well Plus 5 Source Type: news

Medtronic lands CE Mark for quad MRI-safe pacers
Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its line of quadripolar, MRI-safe cardiac resynchronization therapy pacemakers. The approval covers Medtronic’s Percepta, Serena and Solara devices, the Fridley, Minn.-based company said. The devices are slated to the hit the European market in March. “With the addition of quadripolar CRT-P devices to our heart failure portfolio, we now offer a comprehensive line of CRT devices to further meet the needs of patients throughout Europe,” heart failure GM Dr. David Steinhaus said in prepared remarks. “O...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Imaging Regulatory/Compliance Medtronic Source Type: news

FDA clears Biotronik ’ s Pro-Kinetic Energy cobalt chromium stent
Biotronik said today it won FDA approval for its Pro-Kinetic Energy cobalt chromium coronary stent system, with indication for use in patients with arterial blockages between 2.25 and 4mm in diameter and lesion length up to 31 mm. The Pro-Kinetic Energy stent system is designed to imProve coronary luminal diameter in patients with new or recurring blockages in the coronary arteries. The Berlin, Germany-based company said FDA apProval of the device based off of results from its Biohelix-I clinical study. “We’re proud to make the Pro-Kinetic Energy stent available to physicians and their patients in the US. ...
Source: Mass Device - February 15, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Stents Biotronik Source Type: news

VisCardia closes $13m Series B, picks up Inovise Medical assets & tech
Novel heart failure device developer VisCardia said yesterday it closed a $12.5 Series B financing round and picked up the Inovise Medical’s assets and technology rights. Technology and assets from Inovise will support the continued development of VisCardia’s proprietary implantable heart failure therapy device, the Portland, Ore.-based company said. VisCardia’s implantable heart failure system is designed to stimulate the thoracic cavity musculature to mechanically augment cardiac systole and diastolic filling for heart failure patients with reduced ejection fraction and normal ventricular electrical con...
Source: Mass Device - February 2, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Mergers & Acquisitions VisCardia Source Type: news

Biotronik receives FDA warning on Berlin plant; launches Ilivia CRT-Ds
The FDA this week released a warning letter it sent to Biotronik  over issues it identified during an inspection of its facilities in Berlin, shortly after the company announced the launch of its Ilivia cardiac resynchronization therapy devices. In the letter, the federal watchdog referenced 6 specific violations and warned that “given the serious nature of the violations” that the agency was “taking steps to refuse entry of the devices into the United States.” The 1st noted violation was a failure to ensure that processes which cannot be fully verified by subsequent inspections and tests ...
Source: Mass Device - February 1, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news

Defibrillator Only or CRT-D? It Depends, Even When Both Indicated Defibrillator Only or CRT-D? It Depends, Even When Both Indicated
Whether patients eligible for cardiac resynchronization therapy actually get it with an ICD can depend on certain clinical features, type of insurance, and the operator's volume and certification.Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 27, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for November 14, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Final FDA rules clarify adverse event reporting for contract manufacturers The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burde...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA approves Medtronic ’ s Claria MRI quad CRT-D
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its Claria MRI quad cardiac resynchronization therapy defibrillator for magnetic resonance imaging scans at both 1.5 and 3 Tesla. “The Claria MRI CRT-D is our latest innovation to help improve patients’ response to CRT, establishing a new level of personalized care,” heart failure GM Dr. David Steinhaus said in prepared remarks. “And it further expands our industry-leading MR-conditional portfolio of devices, which are helping to improve the lives of more patients throughout the world.” “Until now,...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news

Boston Scientific launches Dakota nitinol kidney stone retrieval device
Boston Scientific (NYSE:BSX) said today it launched its Dakota nitinol retrieval device designed for kidney stone retrieval in the U.S. and Europe. The Dakota stone retrieval device is designed to work with kidney stones of multiple sizes, ranging from 1 mm to 10 mm, Marlborough, Mass.-based Boston Scientific. “The Dakota Retrieval Device with OpenSure Handle offers innovative technology that helps me solve some of the challenges faced during ureteroscopy procedures. I can extract a variety of stone sizes and compositions and make multiple passes during one procedure to help patients become stone free,” Dr...
Source: Mass Device - November 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Urology Boston Scientific Source Type: news

MassDevice.com +5 | The top 5 medtech stories for November 7, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. First patient receives Pixium bionic vision implant Pixium Vision said today that the 1st patient in the UK was implanted with its IRIS II bionic vision system. The epi-retinal implant has 150 electrodes and a bio-inspired came...
Source: Mass Device - November 7, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

St. Jude wins CE Mark for MRI safe labeling for Quadra CRT-P
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union to add magnetic resonance imaging conditional labeling to its Quadra Allure MP cardiac resynchonization therapy pacemaker. The company’s Quadra Allure MP CRT-P is now cleared as operable with diagnostic MRI scans of up to 1.5 Tesla, the St. Paul, Minn.-based company said. “The Quadra Allure MP is the only CRT-P with MultiPoint Pacing technology, MRI full-body labeling, and more clinical options to treat patients who don’t respond to initial pacing therapy. This new technology allows patients who have heart failu...
Source: Mass Device - November 7, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance St. Jude Medical Source Type: news

Boston Scientific, University of Alabama settle CRM patent spat
Boston Scientific (NYSE:BSX) and the University of Alabama settled a patent dispute over cardiac rhythm management technology. The spat spans back to 2014, when the University of Alabama at Birmingham and the UAB Research Foundation filed a lawsuit against Boston Scientific and Cardiac Pacemakers, saying that the companies infringed on its patent by making, using, offering and selling cardiac resynchronization therapy defibrillators. The suit was stayed in August 2015 while Boston Scientific pursued inter partes review with the U.S. Patent & Trademark office, Boston Scientific said last week in a regulatory filing...
Source: Mass Device - November 7, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Legal News Patent Infringement Boston Scientific Cardiac Rhythm Management Source Type: news

St. Jude Medical Gains CE Mark Approval for MRI Labeling of its Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker
ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (STJ), a global medical device company, today announced CE Mark approval for magnetic resonance (MR) conditional labeling for the company’s Quadra Allure MP™ cardiac resynchron... Devices, Cardiology, Radiology, Regulatory St. Jude Medical, Quadra Allure MP, Cardiac Resynchronization Therapy, Pacemaker (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 7, 2016 Category: Pharmaceuticals Source Type: news

Report: St. Jude sold off older CRM devices after learning of battery issue
St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according to a StarTribune report. The devices were recalled in 2015 over issues with batteries failing with little to no warning, an issue which resulted in 2 deaths, according to the report. Despite fixing the problem and producing new, updated units, St. Jude continued to distribute the older devices indicated in the recall for 17 months. Executives at St. Jude reportedly “moved as quickly as possible with the information ...
Source: Mass Device - November 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Recalls St. Jude Medical Source Type: news

CRT May Help Infants Recover After Biventricular Heart Surgery CRT May Help Infants Recover After Biventricular Heart Surgery
Temporary cardiac resynchronization therapy can boost blood pressure in infants with wide-QRS intervals after surgery for some forms of congenital heart disease, suggests a small randomized study.Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 6, 2016 Category: Consumer Health News Tags: Cardiology News Source Type: news

Medtronic issues urgent field safety notice for select ICDs, CRTds
Medtronic (NYSE:MDT) issued an urgent field safety notice concerning issues with specific units of its Viva cardiac resynchronization therapy defibrillators and Evera implantable cardioverter defibrillators that could result in rapid battery depletion. The Fridley, Minn.-based company sent the notice on August 12 to healthcare professionals managing patients with the devices. The notice warned of issues with 78 specific Viva CTR-D and Evera ICDs related to a specific subset of circuit components which may have a low resistance path that could result in rapid battery depletion. Medtronic said that, based on its records, 53 ...
Source: Mass Device - September 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 22, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. LivaNova launches next-gen ICD, CRT-Ds in US LivaNova said today it is launching its next-gen Platinium implantable cardiac defibrillators and cardiac resynchronization therapy devices in the U.S. The next-gen devices include i...
Source: Mass Device - September 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

LivaNova launches next-gen ICD, CRT-Ds in US
LivaNova (NSDQ:LIVN) said today it is launching its next-gen Platinium implantable cardiac defibrillators and cardiac resynchronization therapy devices in the U.S. The next-gen devices include improved longevity and lower energy consumption, with service life projected over 14 years for single-chamber ICDs, 13 years for dual-chamber ICDs and 10 years for CRT-D devices, LivaNova said. “The technology we have developed will provide U.S. physicians and patients a broader range of devices offering the longest projected longevity of any on the market. Platinium addresses the medical community requests in closing the ...
Source: Mass Device - September 22, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular LivaNova Source Type: news

EBR Systems wins FDA nod for wireless pacer trial
EBR Systems said today it won an investigational device exemption from the FDA for a clinical trial of its WiSE wireless cardiac resynchronization therapy device. The Sunnyvale, Calif.-based company claimed the device as the world’s only wireless, endocardial pacing system for stimulating the left ventricle. “WiSE is unique, significant technology that’s cleared for use in Europe and has proven very beneficial thus far. This important medical advance addresses major shortcomings in current [cardiac resynchronization therapy] implants and could dramatically improve success rates fo...
Source: Mass Device - September 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance EBR Systems Inc. Source Type: news

Biotronik hits the market in Japan with Ilivia MRI-safe ICD
Biotronik said yesterday it launched its Ilivia magnetic resonance imaging-safe implantable cardioverter defibrillator in Japan. The Berlin-based comapny said the Ilivia device features both its ProMRI technology and its MRI AutoDetect feature which automatially recognizes when the user is in an MRI environment and switches to MRI mode. The device then switches back to normal functionality when MRI fields are no longer detected. “It’s only recently that MRI conditional devices have become the gold standard in CIEDs. These devices have seen continuous improvements, with the latest being the MRI AutoDetect functi...
Source: Mass Device - September 6, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Biotronik Source Type: news

Medtronic Technologies Improve Delivery of Cardiac Resynchronization Therapy
Medtronic plc (NYSE:MDT) today announced results from the Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee) study. The study showed that the Medtronic-exclusive device-based EffectivCRT ™ during AF algorithm improves therapy delivery in heart failure patients with atrial fibrillation (AF). The results were presented at the 2016 European Society of Cardiology (ESC) Congress in Rome. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 3, 2016 Category: Cardiology Source Type: news

Researchers: Short-seller ’ s claims about St. Jude Medical devices have ‘ major flaws ’
A short-seller’s report that cardiac rhythm management devices made by STJ are vulnerable to hackers has “major flaws” and doesn’t prove its allegations, according to researchers from the University of Michigan. Muddy Waters, the firm founded by well-known short-seller Carson Block, last week aimed to disrupt the pending, $25 billion acquisition of St. Jude by Abbott (NYSE:ABT); in addition to his bet that STJ share prices will fall, Block is long on ABT shares. His shop and a startup cybersecurity business called MedSec alleged last week that St. Jude’s implanted card...
Source: Mass Device - August 30, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Legal News Wall Street Beat St. Jude Medical Source Type: news

Medtronic to cover HeartWare ’ s cash burn by cutting back on other heart failure R & D
Medtronic (NYSE:MDT), which earlier this week closed on the $1.1 billion buyout of implantable cardiac pump maker HeartWare, plans to cover HeartWare’s cash burn by cutting other heart failure R&D programs, the company executives said yesterday. HeartWare’s implantable left ventricular assist devices are designed for end-stage heart failure patients, either as a destination therapy until death or as a bridge to heart transplantation. “[W]e had a number of investments internally going on in R&D programs directed specifically at heart failure, including diagnostic programs and services, as...
Source: Mass Device - August 26, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular MassDevice Earnings Roundup Mergers & Acquisitions Research & Development Wall Street Beat HeartWare International Inc. Medtronic Source Type: news