FDA warns Medtronic on CRM plants in Minnesota, Puerto Rico
The FDA this week released warning letters it sent to Medtronic (NYSE:MDT) over issues with cardiac rhythm management plants in Minnesota and Puerto Rico. The federal safety watchdog said inspections in April and May at both plants turned up problems related to the recall of CRM devices over high-voltage arcing, which led to the recall of some 800 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. In January the Fridley, Minn.-based company informed physicians of the recall of 48 of the devices that were “sent through a manufacturing sequence that introduced the po...
Source: Mass Device - September 12, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Warning Letter Source Type: news

Medtronic launches ECG belt HF optimization trial
Medtronic (NYSE:MDT) said today it launched a new clinical trial evaluating the use of its ECG belt research system as a diagnostic tool for improving cardiac resynchronization therapy for heart failure patients. The Fridley, Minn.-based company said it has enrolled the first patients in the trial at Des Moines, Iowa’s Mercy Medical Center – West Lakes by principal investigator Dr. Troy Hounshell. “The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of implant and also during follow-up visits. By pairing CRT with the ECG Belt, we ha...
Source: Mass Device - July 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Medtronic Source Type: news

Thousands of Medtronic CRM devices need software upgrades
The FDA this week released notices from Medtronic (NYSE:MDT) warning of software issues with approximately 41,000 cardiac rhythm management devices. The warnings affect approximately 29,000 EnTrust and Escudo implantable cardioverter defibrillator devices and approximately 12,000 Percepta and Percepta Quad cardiac resynchronization therapy devices, according to urgent field notices sent out by the Fridley, Minn.-based company in June. The recalls have been labeled as Class 2 by the FDA, and no deaths have been reported related to the issues, according to Medtronic. The company said that its EnTrust and Escudo ICDs may...
Source: Mass Device - July 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Medtronic Source Type: news

Medtronic & #039;s Value-Based Partnerships are Paying Off in Spades
Dublin, Ireland-based Medtronic continues to lead the charge toward value-based care, and it's beginning to pay off in a big way.  One of the company's value-based care partners, UnitedHealthcare, has seen a 27% decline in the rate of preventable hospital admissions for Medtronic insulin pump users compared to patients on multiple daily insulin injections, according to an analysis of more than 6,000 members with diabetes on Medtronic MiniMed 630G and previous generation insulin pumps. And that's just in the first year of the partnership. The analysis included a mix of members using both standalone insulin pumps and pu...
Source: MDDI - July 11, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Size Might Matter for CRT to Work in Narrow-QRS Heart Failure Size Might Matter for CRT to Work in Narrow-QRS Heart Failure
Should cardiac resynchronization therapy indications consider ventricular size with narrower QRS intervals? It's'pretty bold'to suggest the guidelines might need revising, said an observer.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 12, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

MicroPort < sup > ® < /sup > CRM Announces PMDA Approval in Japan of PLATINIUM ™ 4LV SonR < sup > ® < /sup > CRT-D < br > < span style= " font-size:14px; line-height:22px; " > < i > PLATINIUM ™ 4LV SonR* combines quadripolar IS-4 left ventricular pacing options with SonR, the world's first and only sensor-based therapeutic optimization, for cardiac resynchronization therapy. < /i > < /span >
(Source: Microport News Release)
Source: Microport News Release - June 3, 2018 Category: Medical Devices Source Type: news

Medtronic touts improved patient survival in AdaptivCRT algorithm study
Medtronic (NYSE:MDT) today released results from a study of its AdaptivCRT algorithm, touting that the use of the algorithm increased patient survival. Results from the trial were presented last week at the Heart Rhythm Society’s annual scientific sessions in Boston, the Fridley, Minn.-based company said. The AdaptivCRT algorithm is designed to personalize cardiac resynchronization therapy and adjusts how implanted CRT devices pace the heart according to evaluations of the patient’s heart rhythm, Medtronic said. In the AdaptResponse prospective registry study, researchers explored the use of the Adapt...
Source: Mass Device - May 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Medtronic Source Type: news

Recognizing Left Bundle Branch Block and When It Matters Recognizing Left Bundle Branch Block and When It Matters
These Mayo Clinic experts illustrate how to identify LBB on ECG, what measures to take to correct it, and novel developments in cardiac resynchronization therapy.Mayo Clinic (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 30, 2018 Category: Consumer Health News Tags: Cardiology Roundtable Source Type: news

Abbott releases cybersecurity, battery update for high-voltage implantable cardiac devices
Abbott (NYSE:ABT) today announced a firmware upgrade for its high-voltage implantable cardiac devices looking to shore up cybersecurity and improve battery performance. The company stated that while the update is intended to improve cybersecurity through an additional layer of protection against unauthorized device access, it has not received any reports that any of its devices have been exploited remotely. Abbott also said that it has not identified any new vulnerabilities in its cardiac device portfolio. The newly released firmware upgrade includes an enhanced device-based battery performance alert, Abbott said...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Abbott Source Type: news

CMS approves expanded MRI coverage for CRM patients
The Centers for Medicare & Medicaid Services have finalized a plan that will cover magnetic resonance imaging scans for patients with implanted cardiac devices, including pacemakers, cardioverter defibrillators and cardiac resynchronization therapy devices, according to a MedPage Today report. The finalized decision, which was released in January, will allow Medicare patients with MR-conditional devices to have their MRI scans covered by the national healthcare program. Patients with non-MR-conditional devices will also be reimbursed, but only when the MRI machine is 1.5 Tesla or less in normal operating mode, accordin...
Source: Mass Device - April 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Imaging Wall Street Beat Centers for Medicare and Medicaid Services (CMS) Source Type: news

Medtronic touts reduced AF, improved activity in AdaptivCRT studies
Medtronic (NYSE:MDT) today released results from two real-world analyses of its AdaptivCRT algorithm, touting that its use was linked to a reduction in atrial fibrillation episodes and higher patient activity levels. Results from the analyses, which involved a total of 408 patients at 26 centers in Italy, were presented at the European Heart Rhythm Association’s Scientific Sessions 2018 in Barcelona, Spain, the company said. Medtronic’s AdaptivCRT algorithm is designed to adjust pacing to the heart dependent upon evaluations of heart rhythm made every minute, the company said. The program has been sho...
Source: Mass Device - March 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Software / IT Medtronic Source Type: news

Medicare: Hospitals mishandled warranty credits for recalled cardiac devices
A number of US Hospitals have failed to appropriately pay Medicare for warranty credits received from cardiac device manufacturers for recalled devices, according to a new report from the Dept. of Health and Human Services Office of Inspector General. In the report, a total of 296 payments for recalled cardiac devices were reviewed, and all were found to have not complied with Medicare requirements for reporting manufacturing credits resulting in a total of $4.4 million in overpayments from CMS. The reported payments came from 210 hospitals investigated in the report which performed procedures to replace defective or recal...
Source: Mass Device - March 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Centers for Medicare and Medicaid Services (CMS) Dept. of Health & Human Services (HHS) Source Type: news

EBR Systems launches trial for wireless pacer
EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval. Sunnyvale, Calif.-based EBR’s device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient-specific location inside the left ventricle. The FDA approv...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management EBR Systems Inc. Source Type: news

Class I Medical Device Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery https://go.usa.gov/xnzxy   #MedicalDevice
Class I Medical Device Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery https://go.usa.gov/xnzxy  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Medtronic recalls 48 CRM devices on arcing risk
Medtronic (NYSE:MDT) informed physicians last month of a problem with 48 of its cardiac rhythm management devices that’s prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality,” according to a January doctors letter from quality & regulatory VP Tim Samsel. The issue led to a single instance in which an implant...
Source: Mass Device - February 27, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Recalls Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news

Medtronic is Making the Most of Value-Based Care
Medical device companies of all sizes have embraced value-based healthcare in recent years, and one of the industry's top companies is now beginning to see its value-based care programs pay off. "I know I have spoken a lot about value-based healthcare, but I'm particularly pleased to see this translate into real numbers, which have real differentiating value for Medtronic," CEO Omar Ishrak said during Medtronic's third-quarter earnings call Tuesday, according to Seeking Alpha transcripts. Learn more about the future of innovation in the value-based care system at the BIOMEDevice Boston conference, April 18-1...
Source: MDDI - February 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

CMS mulls expanded MRI coverage for CRM patients
The Centers for Medicare & Medicaid Services is thinking about extending coverage for magnetic resonance imaging scans to patients with cardiac rhythm management devices after reviewing studies showing that MRI scans are safe. If finalized the decision would allow Medicare patients with implanted MR-conditional devices such as pacemakers or defibrillators to have their MRI scans covered by the national healthcare program. “We propose that the evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator ...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Wall Street Beat Cardiac Rhythm Management Centers for Medicare and Medicaid Services (CMS) Source Type: news

Sensor glitch prompts Boston Scientific warning on pacemakers
Boston Scientific (NYSE:BSX) last month warned physicians of a sensor glitch with some of its pacemakers that could lead to fainting episodes. In a December “Dear Doctor” letter, Marlborough, Mass.-based Boston Scientific said it received reports of “intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems.” The problem can occur with any company’s pacing leads, but an internal investigation showed that it was most likely to happen with right atrium or right ventricle leads made b...
Source: Mass Device - January 12, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Source Type: news

Abbott Expands Portfolio of MRI-Ready Devices
FDA gave MR-conditional labeling to two of Abbott's cardiac rhythm management (CRM) devices, a move that further boosts the company's ability to compete with its peers in the space. The Abbott Park, IL-based firm said patients who receive a Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) or a Fortify Assura implantable cardioverter defibrillator (ICD) are now able to have an MRI in the future if need be. The Quadra Assura and the Fortify Assura are two of Abbott's most widely-used high voltage devices, the company noted. In September 2016, Abbott won FDA approval for MR-conditional labeling for the...
Source: MDDI - January 3, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Regulatory and Compliance Source Type: news

Abbott gains on Morgan Stanley upgrade, touts MR conditional FDA labeling
Abbott (NYSE:ABT) shares have risen approximately 1.3% after the company received an upgrade from a Morgan Stanley analyst and won updated MR-conditional labeling from the FDA for two of its cardiac pacing devices. The share price rise came after Morgan Stanley analyst David Lewis yesterday lifted the price target for the company from $60 to $67, according to a Benzinga report. The lift was due to the company’s device pipeline, including tis Libre and Confirm devices, which Lewis said could drive organic revenue growth acceleration to greater than 6%, according to the report. Lewis said that that strength, along...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

Appeals court tosses whistleblower suit against Biotronik
The plaintiff in a whistleblower lawsuit against Biotronik only gets one bite at the apple, a federal appeals court ruled last week in tossing the False Claims Act suit. The U.S. Court of Appeals for the Ninth Circuit upheld the dismissal of the second lawsuit brought by Max Bennett, a former Biotronik employee who alleged that the company ran a kickbacks scheme to entice doctors into using its cardiac rhythm management products. Bennett had filed his first suit shortly after another ex-Biotronik worker’s suit made similar allegations. Biotronik agreed to pony up $4.9 million, but admitted no wrongdoin...
Source: Mass Device - December 4, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Biotronik Cardiac Rhythm Management Whistleblower (qui tam) lawsuit Source Type: news

How Medtronic & #039;s Pacemakers Are Now Harder to Hack
FDA approved Medtronic's Azure pacemakers, which feature the company's new BlueSync technology to protect patients from having their device hacked. The BlueSync technology is also now available with the Medtronic Percepta portfolio of quadripolar, MR-conditional cardiac resynchronization therapy pacemakers (CRT-Ps), the company said. BlueSync is intended to enable more secure wireless remote monitoring via Medtronic's CareLink Network, by limiting access to the device functionality and also by protecting patient data. Connected medical devices like pacemakers add value to patient care by enabling remote patient monito...
Source: MDDI - November 21, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Cardiovascular Source Type: news

Why LivaNova Is Unloading Its CRM Business
LivaNova, formerly known as Sorin Group, has decided to get out of the cardiac rhythm management (CRM) business and shift more focus to its areas of strength.  The London-based company plans to sell its CRM business to Shanghai-based MicroPort for $190 million in cash. The business, which makes high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers, generated about $249 million in net sales in the fiscal year 2016. The business has roughly 900 employees with operations chiefly in Clamart, France; Saluggia, Italy; and Santo Domingo, Dominican Republic. The company said in Sept...
Source: MDDI - November 20, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Medical Device Business Source Type: news

Medtronic wins FDA nod for Azure remote monitoring equipped pacers
Medtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology. The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices. The Azure portfolio of pacers feature the company’s Reactive ATP algorithm intended to slow the progression of atrial fibrillation and BlueSynch technology which allows f...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news

EBR Systems pulls in $50m for wireless pacer
EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pe...
Source: Mass Device - November 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Funding Roundup Regulatory/Compliance Wall Street Beat Cardiac Rhythm Management EBR Systems Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for October 13, 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 tips for selecting and managing a medtech development partner There many things to consider when searching for and interacting with a product development firm – and the stakes are high! Most early-stage medical device ...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic, Mercy hospitals ink data-sharing deal
Medtronic (NYSE:MDT) and the Mercy healthcare system today said they inked a data sharing and analysis deal to gather clinical evidence for “medical device innovation and patient access.” The program aims to gather efficacy and safety data generated during routine care, rather than via expensive and time-consuming clinical trials. The first phase is designed to collect anonymized data from some 80,000 heart failure patients treated with cardiac resynchronization therapy. “Having the ability to study patient care pathways and conditions before and after exposure to a medical device is crucial to understand...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Big Data Hospital Care Wall Street Beat Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 25, 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. EY is upbeat about the medical device industry: Here’s why The medical device industry is growing, at a healthy and steady pace. This is according to EY’s Pulse of the Industry report, which was released today at Ad...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

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 Announces U.S. FDA Approval for MRI Labeling on High-Voltage Devices and U.S. Launch of Resonate(TM) Devices with the HeartLogic(TM) Heart Failure Diagnostic
MARLBOROUGH, Mass., Sept. 25, 2017 -- (Healthcare Sales & Marketing Network) -- Boston Scientific (NYSE: BSX) has launched the Resonate™ family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) sys... Devices, Cardiology, FDA Boston Scientific, Resonate, ICD , CRT-D, SmartCRT, HeartLogic (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 25, 2017 Category: Pharmaceuticals 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