Medtronic Announces Reimbursement Approval and Launch of CoreValve ™ Evolut™ R System in Japan
Medtronic plc (NYSE: MDT) today announced it has received reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the recapturable, self-expanding transcatheter CoreValve ™ Evolut™ R System for patients with severe aortic stenosis (AS) unable to undergo surgery, and for whom treatment with transcatheter aortic valve implantation (TAVI) is determined to be the best option. This approval follows the Shonin approval from the MHLW the company received in November.U (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - December 1, 2016 Category: Cardiology Source Type: news
For Aortic Stenosis, TAVR Shows Short-term QoL Benefit For Aortic Stenosis, TAVR Shows Short-term QoL Benefit
Quality-of-life scores improved over 1 month for TAVR patients, but only with transfemoral access, not transthoracic; but surgical-valve replacement patients caught up after a year.Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - November 7, 2016 Category: Cardiology Tags: Cardiology News Source Type: news
Innovation seen in transcatheter aortic valve replacement
Great strides are being made in the treatment of heart disease with innovative new treatment options for valvular heart disease.
Since 2007, I’ve had the privilege of serving on a team of Emory physicians that has helped revolutionize the treatment of severe aortic stenosis, leading the national effort to study and advance a new nonsurgical procedure called transcatheter aortic valve replacement or TAVR.
Aortic stenosis is a dangerous heart condition that affects tens of thousands of Americans… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 31, 2016 Category: Pharmaceuticals Authors: Vinod Thourani Source Type: news
Edwards Lifesciences wins CE Mark for Inspiris Resilia aortic valve
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Inspiris Resilia aortic valve.
The Irvine, Calif.-based company said the valve is the 1st in a “new class of resilient heart valves” which incorporate its Resilia tissue and features a Perimount Magna ease valve and VFit technology for future valve-in-valve procedures.
“The Inspiris valve creates a new class of surgical valves and includes key patient-focused innovations, such as the resilient tissue and the VFit technology, to advance the treatment of patients with heart valve disease. In partnership with sur...
Source: Mass Device - September 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Edwards Lifesciences Source Type: news
Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements.
The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead to strokes.
“Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures. These studi...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Stroke Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 19, 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.
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5. Edwards Lifesciences wins expanded CE Mark for Sapien 3 replacement heart valve
Edwards Lifesciences said today that it won CE Mark approval in the European Union for an expanded indication for its Sapien 3 transcatheter aortic...
Source: Mass Device - September 19, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Edwards Lifesciences wins expanded CE Mark for Sapien 3 replacement heart valve
Edwards Lifesciences (NYSE:EW) said today that it won CE Mark approval in the European Union for an expanded indication for its Sapien 3 transcatheter aortic valve replacement.
The expanded indication covers patients at intermediate risk for open heart surgery, Irvine, Calif.-based Edwards said. Last month the FDA also expanded the Sapien 3 indication to include intermediate-risk aortic stenosis patients. The device won its original CE Mark approval back in January 2014, with the U.S. federal safety watchdog following suit in June 2015.
“This expanded intermediate-risk indication allows for the treatment of even mo...
Source: Mass Device - September 19, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Regulatory/Compliance Replacement Heart Valves Wall Street Beat Edwards Lifesciences Source Type: news
Boston Scientific wins CE Mark for Lotus Edge heart valve
Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for its Lotus Edge, the next generation of its transcatheter aortic valve replacement.
Marlborough, Mass.-based Boston Scientific said it plans to make the Lotus Edge valve available to “select centers” in Europe, accelerating the growth of its commercial footprint “as physicians and centers become fully trained.” The original Lotus TAVR won a CE Mark back in October 2013.
Like its predecessor, the Lotus Edge valve is designed to reduce the paravalvular leakage that plagued early TAVR devices, but its deliver...
Source: Mass Device - September 19, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Regulatory/Compliance Replacement Heart Valves Boston Scientific Source Type: news
FDA approves Intuity Elite rapid valve from Edwards Lifesciences
The FDA approved the Intuity Elite rapid deployment replacement aortic valve made by Edwards Lifesciences (NYSE:EW).
Irvine, Calif.-based Edwards said the Intuity Elite valve is designed to create more time during the treatment of complex heart failure cases for procedures to treat other facets of the disease. It’s on the U.S. market now, the company said.
The Intuity Elite valve won CE Mark approval in the European Union in April 2014.
“U.S. approval of the Edwards Intuity Elite valve system is a significant milestone as this technology provides an advanced surgical treatment option for patients suffering f...
Source: Mass Device - August 15, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
TAVR: Study shows benefit of Claret Medical ’ s Sentinel cerebral protection device
A study released this week reported that the use of Claret Medical‘s cerebral protection device during transcatheter aortic valve implantation procedures in patients with severe aortic stenosis can reduce the number and volume of brain lesions.
The study, which received funding from Claret and Medtronic (NYSE:MDT), was published in the August 9 issue of the The Journal of the American Medical Association.
“First, as other studies have noted, emboli to the brain that cause infarction detected on MRI are very common with TAVI. In this trial, acute lesions on MRI were present in virtually all patients enrolled, a...
Source: Mass Device - August 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Cardiovascular Catheters Clinical Trials Claret Medical Inc. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for August 1, 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. Haemonetics sees shares rise on Q1 release
Haemonetics has seen shares rise despite releasing 1st quarter earnings that saw losses grow and earnings per share shrink compared to last year.
The Braintree, Mass.-based company rep...
Source: Mass Device - August 1, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
CoreValve Evolut R First TAVR to Receive CE Mark for Intermediate Risk Patients
This morning Medtronic plc (NYSE: MDT) announced that its recapturable and repositionable CoreValve Evolut R System has received the CE Mark to treat patients with severe aortic stenosis who are at intermediate risk for open-heart surgery, making the CoreValve Evolut R the first TAVR device to obtain approval for this patient population. Previously TAVR devices were indicated for use only in patients at high risk for surgery. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - August 1, 2016 Category: Cardiology Source Type: news
Medtronic wins expanded CE Mark for Evolut R TAVR system
Medtronic (NYSE:MDT) said today it won expanded CE Mark approval in the European Union for its CoreValve Evolut R transcatheter aortic valve replacement, now approved for aortic stenosis patients at intermediate risk for open-heart surgery.
The Fridley, Minn.-based company touted the win, saying it is the 1st TAVI system to have received expanded indication in Europe for patients at intermediate risk for open heart surgery.
“The unique design of the self-expanding, supra-annular Evolut R System, coupled with its ability to be recaptured and repositioned for accurate valve placement, enables this device to be a viabl...
Source: Mass Device - August 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Regulatory/Compliance Medtronic Source Type: news
Simple risk score may aid TAVR candidate selection
A simple scoring system that takes comorbidity, frailty and disability into account can effectively stratify early and late mortality rates among extreme- and high-risk patients with aortic stenosis undergoing transcatheter aortic valve replacement, US researchers report. (Source: MedWire News)
Source: MedWire News - July 29, 2016 Category: Consumer Health News Tags: Interventional cardiology Source Type: news
