MassDevice.com +5 | The top 5 medtech stories for June 28, 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. Sweden’s Handicare acquires mobility device developer Prism Medical Prism Medical said today that mobility and technical aid developer Handicare agreed to acquire it for approximately $62 million. Swedish Handicare, which...
Source: Mass Device - June 28, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic launches Beacon HF monitoring service
Medtronic (NYSE:MDT) said today it launched its Beacon heart failure management service in the U.S., designed to monitor data from cardiac pacing devices to improve early interventions before heart failure events. The service, which integrates data from the company’s implantable cardioverter defibrillator and cardiac resynchronization therapy devices, will allow patients to engage in daily health checks to both educate patients about conditions and to collect symptoms and biometrics. “Beacon is a significant advance in our heart failure management arsenal. With its combination of valuable device diagn...
Source: Mass Device - June 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Patient Monitoring Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 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. J&J investor relations veep Mehrotra retires, Wolk steps up Johnson & Johnson said today its 10-year vice president of investor relations Louise Mehrotra will retire, effective January 2017, to be replaced by Joseph Wol...
Source: Mass Device - June 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA warns Medtronic’s Tyrx on anti-bacterial envelopes
The FDA sent a warning letter earlier this month to Medtronic (NYSE:MDT) subsidiary Tyrx over problems with its process validation and quality systems. The Tyrx envelopes are designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days before dissolving over a period of roughly 9 weeks. They’re cleared for use with pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, deep-brain stimulators, sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. Tyrx, which Medtronic acquired for $160 million in Januar...
Source: Mass Device - June 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Regulatory/Compliance Surgical Medtronic TYRX Inc. Warning Letter Source Type: news

Leadless CRT Alternative Slated For U.S.-based Clinical Trial In 2017
New technology that can wirelessly resynchronize the chambers of the heart is making its way toward U.S.-based clinical trials in early 2017. EBR Systems’ WiSE technology is an endocardial pacing system for cardiac resynchronization therapy (CRT), designed to address flaws in conventional CRT systems that are ineffective in one-third of eligible heart failure (HF) patients. (Source: Medical Design Online News)
Source: Medical Design Online News - June 7, 2016 Category: Medical Equipment Source Type: news

HRS 2016 roundup: Leadless pacers at the fore
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), aiming to distinguish their respective leadless pacemaker offerings, presented new data last week in San Francisco at the Heart Rhythm Society’s annual meeting. St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, with no serious adverse events. “We’ve now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability – even up to 3 years – is possibl...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Boston Scientific Cardiac Rhythm Management HRS 2016 Medtronic St. Jude Medical Source Type: news

St. Jude expands EnSite Precision launch in EU, seeks FDA approval
St. Jude Medical (NYSE:STJ) said today it is expanding its commercial release of its EnSite Precision cardiac mapping system in the European Union, and that it is currently pursuing FDA clearance of the system. The St. Paul, Minn.-based company’s Ensite cardiac mapping system is designed for use in ablation procedures to visualize and aid in catheter navigation in the heart, providing detailed anatomical models and maps. The system is designed to aid in diagnosing arrhythmias, guiding therapy and providing expanded procedural options. “We developed the EnSite Precision system with insight from world-renown...
Source: Mass Device - April 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blog St. Jude Medical Source Type: news

St. Jude Medical Announces Launch And First US Implants Of MultiPoint Pacing Technology
St. Jude Medical, Inc. , a global medical device company, recently received U.S. Food and Drug Administration (FDA) approval of the company’s proprietary, first-to-market MultiPoint Pacing technology and today announced the U.S. launch and first U.S. implants of the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D). (Source: Medical Design Online News)
Source: Medical Design Online News - April 19, 2016 Category: Medical Equipment Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 18, 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. St. Jude Medical touts 1st U.S. commercial implantations for Quadra Assura with MultiPoint pacing St. Jude Medical today touted the 1st U.S. commercial implantations for its Quadra Assura MP cardiac resynchronization therapy de...
Source: Mass Device - April 18, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

St. Jude Medical touts 1st U.S. commercial implantations for Quadra Assura with MultiPoint pacing
St. Jude Medical (NYSE:STJ) today touted the 1st U.S. commercial implantations for its Quadra Assura MP cardiac resynchronization therapy defibrillator, featuring its MultiPoint pacing technology. The MultiPoint tech is the 1st to hit the U.S. market that allows physicians to tailor pacing therapy by controlling multiple pulses to the left ventricle for each heartbeat. Each lead in the system can deliver 2 pulses per heartbeat, St. Jude said. Last month the Little Canada, Minn.-based company won CE Mark approval in the European Union for 3 new Quartet left ventricular leads; in February, St. J...
Source: Mass Device - April 18, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Wall Street Beat Cardiac Rhythm Management St. Jude Medical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 29, 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. The exodus of key personnel at Google’s Verily There’s reportedly a rare exodus under way of key personnel from a Google operation, its Verily healthcare “moonshot,” with former employees blaming the merc...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

St. Jude wins CE Mark for expanded suite of cardiac leads
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union and launched 3 new Quartet left ventricular leads. The newly released leads are designed for more effective targeting of individual cardiac anatomies for patients who require cardiac resynchronization therapy pacers and defibs, the company said. “Heart and blood vessel anatomy vary from patient to patient so having multiple sizes and spacing options with the Quartet quadripolar lead helps me to treat all of my patients in need of cardiac resynchronization therapy. We are now able to place the quadripolar lead in the best possibl...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance St. Jude Medical Source Type: news

Boston Scientific Wins FDA Approval For Quadripolar Leads, Initiates Trial To Expand MRI Labeling
Boston Scientific FDAapproval for the ACUITYX4 Quadripolar Left Ventricular (LV) leads. The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the leads – to the U.S. market. (Source: Medical Design Online News)
Source: Medical Design Online News - February 25, 2016 Category: Medical Equipment Source Type: news

Boston Scientific Receives U.S. FDA Approval For Quadripolar Leads And Initiates Global Trial To Expand MRI Labeling To The U.S. And Asia
FDA-Approved ACUITY™ X4 Quadripolar Left Ventricular Leads to be used in Trial Pursuing MRI Labeling for Cardiac Defibrillation and Resynchronization Systems MARLBOROUGH, Mass., Feb. 23, 2016 -- (Healthcare Sales & Marketing Network) -- Boston Scientif... Devices, Cardiology, FDABoston Scientific, Quadripolar Leads, cardiac resynchronization therapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 23, 2016 Category: Pharmaceuticals Source Type: news

Medtronic Receives CE Mark for Full Line of Cardiac Resynchronization Therapy-Defibrillators Compatible with MRI Scans
Medtronic plc (NYSE:MDT) today announced that it has received CE (Conformité Européenne) Mark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans, providing CRT-D patients with access to the most advanced imaging diagnostic procedures available. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 23, 2016 Category: Cardiology Source Type: news

Medtronic wins CE Mark for line of MR-safe CRT-Ds
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its full line of magnetic resonance imaging safe cardiac resynchronization therapy defibrillators, now approved for use with 3 Tesla MRI machines. The approval includes Fridley, Minn.-based Medtronic’s Claria MRI quad CRT-D SureScan, Amplia MRI quad CRT-D and Compia MRI quad systems, which are also approved for lower-power 1.5 Tesla scanners. “The ability to provide CRT-D patients with access to MRI scans is a significant, necessary advancement that may help save lives. The most common magnetic field strength for an MRI is 1....
Source: Mass Device - February 22, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Clearance Medtronic Source Type: news

Medtronic Earns CE Mark Approval For Full Line OF MRI-Safe CRT-D Devices
Medtronic has received CEMark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla magnetic resonance imaging (MRI) scans, providing CRT-D patients with access to the most advanced imaging diagnostic procedures available. The Claria MRIQuad CRT-D SureScan, Amplia MRI(TM)Quad CRT-D SureScanand Compia MRIQuad CRT-D SureScansystemsare approved for MRI scans without positioning restrictions. (Source: Medical Design Online News)
Source: Medical Design Online News - February 22, 2016 Category: Medical Equipment Source Type: news

St. Jude Gains FDA Approval For Cardiac Pacing, Neurostimulation Technologies
The FDA has approved two new technologies that expand St. Jude Medical’s portfolio for cardiac resynchronization therapy (CRT) and neurostimulation in the U.S. market. St. Jude announced that its MultiPoint Pacing (MPP) technology would be added to the company’s Quadra CRT device offerings in the beginning of 2016, and that the Axium Neurostimulator System was approved for dorsal root ganglion (DRG) stimulation for patients with chronic pain in their lower limbs. (Source: Medical Design Online News)
Source: Medical Design Online News - February 18, 2016 Category: Medical Equipment Source Type: news

St. Jude Medical’s MultiPoint pacing tech wins FDA approval
St. Jude Medical (NYSE:STJ) said the FDA approved its MultiPoint pacing technology for its Quadra Allure defibrillators and pacemakers, plus a new set of quadripolar pacing leads called Quartet LV. The Little Canada, Minn.-based medical device company said the MultiPoint tech is the 1st to hit the U.S. market that allows physicians to tailor pacing therapy by controlling multiple pulses to the left ventricle for each heartbeat. Each lead in the system can deliver 2 pulses per heartbeat, St. Jude said. The new Quartet LV leads have more electrode spacing options and a new, S-curved design, the company said. &ldquo...
Source: Mass Device - February 17, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management St. Jude Medical Source Type: news

Biotronik wins Japanese clearance for MR-safe Itrevia CRT-D
Biotronik said today it won Japanese regulatory clearance for its Itrevia 7 HF-T cardiac resynchronization therapy defibrillator, now approved for full-body MRI-scanning. With the clearance, physicians in Japan are now cleared to perform MRI scans at 1.5 tesla strength on patients implanted with the Itrevia CRT-D. “In addition to having indispensable diagnostic information in the field of cerebrovascular treatment and orthopedics, MRI offers extensive diagnostic cardiovascular information. Many CRT-D patients undergo a cardiac MRI before implantation to assess the late gadolinium enhancement. However, until now ...
Source: Mass Device - February 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Clearance Biotronik Source Type: news

Medtronic Gets FDA Clearance For First MRI-Safe CRT-D Devices
Continuing its track record of introducing the first magnetic resonance imaging (MRI)-safe cardiac devices to the market, Medtronic recently gained approval from the U.S. Food and Drug Administration (FDA) for cardiac resynchronization therapy defibrillators (CRT-Ds) for heart failure patients undergoing MRI scans. (Source: Medical Design Online News)
Source: Medical Design Online News - February 9, 2016 Category: Medical Equipment Source Type: news

FDA Nod to Medtronic MR-Conditional CRT-Defibrillators
The U.S. FDA has cleared the first and only MR-conditional cardiac resynchronization therapy defibrillators (CRT-Ds) for the treatment of heart failure: Medtronic's Amplia and Compia MRI™ Quad CRT-D SureScan® systems. This approval expands Medtronic’s portfolio to include a complete line of MR-conditional cardiac devices, including MR-conditional pacemakers, implantable cardiac defibrillators (ICDs), insertable cardiac monitors (ICMs) and now CRT-Ds. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 5, 2016 Category: Cardiology Source Type: news

MassDevice.com +3 | The top 3 medtech stories for February 5, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.   3. Dehaier restructures to focus on wearables China’s Dehaier Medical Systems said that it plans to ditch its unprofitable medical device businesses so it can focus on its wearable sleep respiratory business. Dehaier said it plans to form a new subsidiary called Connection Wearable Health T...
Source: Mass Device - February 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

FDA approves Medtronic’s Amplia, Complia MRI-safe CRT-Ds
Medtronic (NYSE:MDT) today claimed title to being to only company with cardiac resynchronization therapy defibrillators approved by the FDA for MRI scans. The Fridley, Minn.-based medical device giant said the FDA approved its Amplia and Complia MRI Quad CRT-D SureScan devices for MRI scans on any part of the body without positioning restrictions. Medtronic plans to have the heart failure devices on the market “in the coming months,” according to a press release. “With FDA approval of Amplia MRI and Compia MRI, Medtronic continues to lead the market in MR-conditional implantable cardiac devices, brin...
Source: Mass Device - February 5, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news

FDA approves Medtronic’s Amplia, Compia MRI-safe CRT-Ds
Medtronic (NYSE:MDT) today claimed title to being to only company with cardiac resynchronization therapy defibrillators approved by the FDA for MRI scans. The Fridley, Minn.-based medical device giant said the FDA approved its Amplia and Compia MRI Quad CRT-D SureScan devices for MRI scans on any part of the body without positioning restrictions. Medtronic plans to have the heart failure devices on the market “in the coming months,” according to a press release. “With FDA approval of Amplia MRI and Compia MRI, Medtronic continues to lead the market in MR-conditional implantable cardiac devices, bring...
Source: Mass Device - February 5, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news

Progress and collaboration on clinical trials
By: Barbara D. Buch, M.D. There are few responsibilities at FDA more important than reviewing the design and outcomes of clinical trials. Understanding the science behind the trials — and the individuals included in them — helps us to ensure that the medical products we approve are safe and effective. Last year, FDA took important steps to support the inclusion of diverse populations in clinical trials. Following Congress’s directive in Section 907 of the Food and Drug Administration Safety and Innovation Act, FDA is looking more closely at the sex, age, and race/ethnicity data that are collected in clini...
Source: Mass Device - January 19, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog FDA Source Type: news

St. Jude wins CE Mark for MR-safe Quadra Assura CRT-D
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union for MRI-conditional labelling for its Quadra Assura cardiac resynchronization therapy defibrillator. The Quadra Assura CRT-D is compatible with MRI scanning systems up to 1.5 Tesla, St. Paul, Minn.-based St. Jude said. “The Quadra Assura CRT-D MRI allows patients to continue to be actively paced and continuously monitored with the quadripolar pacing technology while having the capability to get an MRI scan if needed. Being able to offer MRI-compatible technology without compromising care decisions is extremely important; this is...
Source: Mass Device - December 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance St. Jude Medical Source Type: news

MassDevice.com +3 | The top 3 medtech stories for November 24, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.   3. Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo Ocular Therapeutix said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication. Bedford, Mass.-based Ocular Th...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

Mirowsky fights $6m legal tab in Medtronic spat
Mirowski Family Ventures, on the hook for a $6 million tab for Medtronic‘s (NYSE:MDT) legal costs, told a federal appeals court last week that a lower court misconstrued a 24-year-old deal with Eli Lilly (NYSE:LLY). The long-running case involves patents licensed to Boston Scientific (NYSE:BSX). MFV represents the estate of Dr. Michel Mirowski, who helped invent the implantable defibrillator. The group, which controls several patents related to implantable cardioverter defibrillators and cardiac resynchronization therapy devices, has been pursuing patent infringe...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Legal News Patent Infringement Boston Scientific Cardiac Rhythm Management Eli Lilly & Co. Guidant Corp. Medtronic Mirowski Family Ventures Source Type: news

HF Patients May Have Delayed CRT Response (CME/CE)
(MedPage Today) -- Survival rates similar for early and late cardiac resynchronization therapy responders (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - November 17, 2015 Category: Cardiology Source Type: news

St. Jude CEO: CardioMEMS Is Platform Tech For Next Heart Failure Devices
Daniel J. Starks, the chairman, president, and CEO of St. Jude Medical, believes that the company's CardioMEMS sensor will soon become standard of care in heart failure management, and should become a platform technology for future cardiac resynchronization therapy (CRT) and ventricular assist device (VAD) products. (Source: Medical Design Online News)
Source: Medical Design Online News - October 23, 2015 Category: Medical Equipment Source Type: news

FDA clears Medtronic’s Tyrx envelope for DBS devices
Medtronic (NYSE:MDT) said today that it’s launching its Tyrx surgical envelope in the U.S. for use with deep-brain stimulation devices, after it won 510(k) clearance from the FDA for use of the infection-fighting envelope with implantable neurostimulators. Fridley, Minn.-based Medtronic said it’s planning to make the Tyrx device, acquired for $160 million in January 2014, available for other neurostim indications “in the coming months.” The device is designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days. The envelope is designed to then dissolve over a...
Source: Mass Device - October 8, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Surgical Medtronic TYRX Inc. Source Type: news

EBR Systems wins CE Mark for wireless pacer
EBR Systems said Monday it won CE Mark approval in the European Union for its WiSE wireless endocardial cardiac resynchronization therapy device. The EBR device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted on the inside of the heart, in the right ventricle, which it uses to synchronize the left and right ventricles. “A growing body of evidence strongly suggests EBR’s WiSE Technology can benefit patients who have failed conventional cardiac resynchronization implants. We look forward to working with leaders in the European clinical community to further...
Source: Mass Device - October 7, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance EBR Systems Inc. Source Type: news

EBR Systems Receives CE Mark For World's First Wireless Cardiac Pacing System For Heart Failure
EBR Systems, Inc., leading innovator in wireless heart stimulation, today announced European CE Mark (Conformité Européenne) approval for itsWiSE(WirelessStimulationEndocardially) Technology.EBR Systems’ WiSE Technology is the world’s only wireless endocardial pacing system for cardiac resynchronization therapy (CRT). (Source: Medical Design Online News)
Source: Medical Design Online News - October 5, 2015 Category: Medical Equipment Source Type: news

CRT's Obesity Paradox in HF: Long-Term Survival Rises With BMICRT's Obesity Paradox in HF: Long-Term Survival Rises With BMI
Widely recognized but poorly understood, the inverse relationship between heart failure mortality and BMI applies to patients on cardiac resynchronization therapy and may extend at least a decade. Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 1, 2015 Category: Consumer Health News Tags: Cardiology News Source Type: news

MassDevice.com +3 | The top 3 medtech stories for August 25, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.   3. Boston Scientific adds MR-safe label to some EU defibs Boston Scientific said yesterday that it added MR-conditional labeling to the CE Mark for some of the defibrillators it sells in the European Union, claiming the title for Europe’s largest portfolio of MRI-compatible devices. Marlbor...
Source: Mass Device - August 25, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

Boston Scientific adds MR-safe label to some EU defibs
Boston Scientific (NYSE:BSX) said yesterday that it added MR-conditional labeling to the CE Mark for some of the defibrillators it sells in the European Union, claiming the title for Europe’s largest portfolio of MRI-compatible devices. Marlborough, Mass.-based Boston Scientific said its EL extended longevity and Mini implantable cardiac defibrillators and the X4 cardiac resynchronization therapy defibrillators are now cleared to be labeled with the “ImageReady” brand. The company said the news means that nearly all of its high-voltage cardiac rhythm management devices and le...
Source: Mass Device - August 25, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Regulatory/Compliance Boston Scientific Cardiac Rhythm Management CE Mark Source Type: news

Boston Scientific Announces CE Mark For MRI Compatible Labeling For ICD And CRT-D Systems
Boston Scientific Corporation (NYSE:BSX) has received CE Mark on magnetic resonance imaging (MRI) conditional labeling for the current family of EL (Extended Longevity) and MINI implantable cardioverter defibrillator (ICD) and the X4 cardiac resynchronization therapy defibrillator (CRT-D) systems. This revised labeling ensures that future patients and those already implanted with these systems are able to undergo MRI scans if indicated. (Source: Medical Design Online News)
Source: Medical Design Online News - August 25, 2015 Category: Medical Equipment Source Type: news

Biotronik launches 2 new studies
Biotronik announced 2 new studies last week that are slated to examine the company’s CRT-D device and BioMonitor implanted cardiac monitor. A 277-patient BioContinue clinical trial will examine the risk of ventricular arrhythmias after CRT-D replacement, enrolling patients over 2 years at 40 centers across 8 countries, the company said. Biotronik said the trial will be the 1st to investigate defibrillator back-up following device placement in heart failure patients with a primary indication for cardiac resynchronization therapy defibrillators. Patients in the trial will be implanted with Biotronik’s CRT-Ds and ...
Source: Mass Device - August 12, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Research & Development Biotronik Source Type: news

Sorin claims its new CRT-P is the world’s smallest
Sorin Group (BIT:SRN) said today it launched its Reply CRT-P cardiac resynchronization therapy pacemaker, claiming it to be the world’s smallest of its kind. The Reply CRT-P is 11.3 cc in volume, 3.7 cc smaller than Boston Scientific‘s (NYSE:BSX) Intua and 0.2 cc smaller than St. Jude Medical‘s (NYSE:STJ) Anthem CRT-P, according to their respective sites. The device also features the ability to adapt to heart rate due to exercise and avoid inappropriate reactions, Sorin said. The 1st device was implanted at the Papworth Hospital in Cambridge, UK by Dr. Brian Gordon, Sorin said. “The s...
Source: Mass Device - July 31, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Surgical Sorin Group Source Type: news

Medtronic wants $6m for legal fees in Mirowski spat
Medtronic (NYSE:MDT) asked a federal court for a $6 million award to cover its legal costs in the long-running battle with Mirowski Family Ventures involving patents licensed to Boston Scientific (NYSE:BSX). A federal judge in Delaware ruled in June that MFV must cover legal costs in the case, which made it all the way to the U.S. Supreme Court last year. Judge Susan Robinson of the U.S. District Court for Delaware ruled that MFV must cover the legal costs in the case, according to court documents. Last week Medtronic asked Robinson to award more than $6 million in fees, “reflecting...
Source: Mass Device - July 22, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Legal News Cardiac Rhythm Management medtronic Mirowski Family Ventures Source Type: news

Biotronik launches CRT in women study
Biotronik said last week it enrolled the 1st patient in its Biowomen study investigating the difference in cardiac resynchronization therapy response in men and women to understand if women respond better to the treatment. The trial seeks to enroll 247 patients of each gender over 2 years, with a 1-year follow-up and results expected in 2018, the Berlin, Germany-based medical device company said. “We understand that ideal treatment for [heart failure] patients can vary based on age, sex and medical factors, and the best way to understand the patient population is with clinical investigations. Through B...
Source: Mass Device - July 7, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Women's Health Biotronik Source Type: news

Biotronik launches Itrevia MRI-safe quad CRT-D in Japan
Biotronik said today that it launched its Itrevia MRI-safe quad cardiac resynchronization therapy defibrillator in Japan, part of a Japanese rollout of new devices for 2015. The device is equipped with home monitoring connectivity, as well as compatibility with up to 1.5 tesla MRI machines, the German medical device giant said. “As a producer of superior medical technologies, it is imperative for us to have a presence in the world’s leading technologies market. It also makes sense that the world’s biggest producer of ProMRI technology should have a strong presence in the country where MRI scanning is...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Surgical Biotronik Source Type: news

Data Show Medtronic Quadripolar CRT Technology Optimizes Treatment For Heart Failure Patients
Medtronic plc recently announced study results demonstrating that its quadripolar cardiac resynchronization therapy (CRT) system gives physicians more options to optimize CRT delivery, which may improve heart failure patients' response to the therapy. (Source: Medical Design Online News)
Source: Medical Design Online News - May 19, 2015 Category: Medical Equipment Source Type: news

Consumer Information on: Model 5071 Lead - P120017
The Medtronic Model 5071 Lead is a surgically implanted, insulated, and sutureless wire with a screw-in tip that is part of a permanently implanted pacemaker, defibrillator, or cardiac resynchronization therapy (CRT) device. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 8, 2015 Category: Medical Equipment Source Type: news

Consumer Information on: Myopore Sutureless Myocardial Pacing Lead - P130012
The Greatbatch Myopore Sutureless Myocardial Pacing Lead is a surgically implanted, insulated, and sutureless wire with a screw-in tip that is part of a permanently implanted pacemaker, defibrillator, or cardiac resynchronization therapy (CRT) device. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 8, 2015 Category: Medical Equipment Source Type: news

EBR Systems raises $20m for wireless pacer
EBR Systems raises $20 million to propel development and regulatory approval of its wireless cardiac resynchronization therapy device. EBR Systems Inc.News Well, Cardiac Rhythm Management, Funding Roundupread more (Source: Mass Device)
Source: Mass Device - April 10, 2015 Category: Medical Equipment Authors: Mark Hollmer Source Type: news

Some With CRT Might Have Ablation-Amenable PVC CardiomyopathySome With CRT Might Have Ablation-Amenable PVC Cardiomyopathy
Could ablation have helped? Frequent ectopic beats arising from the RV outflow tract were a suspected source of non-CAD cardiomyopathy leading to cardiac resynchronization therapy in a major trial. Heartwire (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 2, 2015 Category: Consumer Health News Tags: Cardiology News Source Type: news

St. Jude Medical Announces CE Mark Approval Of The World's Only MultiPoint Pacing Pacemaker
St. Jude Medical, Inc., a global medical device company, recently announced CE Mark approval of the Quadra Allure MP cardiac resynchronization therapy pacemaker (CRT-P). (Source: Medical Design Online News)
Source: Medical Design Online News - December 15, 2014 Category: Medical Equipment Source Type: news