Cardiac Resynchronization Therapy News 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.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.
“Continu...
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 CMR ...
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, bringing...
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, bringing ...
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 clinical trials.
...
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 yet...
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 infringement cases against Medtronic, Guidant and su...
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
