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.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 patie...
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 European count...
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 imaging...
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.
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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’s ...
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 needs of their pati...
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 the plant in February tur...
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.
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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 its origins back to the e...
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
