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Condition: Heart Valve Disease
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Total 52 results found since Jan 2013.
TCT 2015: Medtronic touts CoreValve TAVI real-world registry data
Update: Added data from study of new patient populations
Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve implant, reporting outcomes in-line with its clinical trials of the device.
The medtech giant also released new data from 3 studies focusing on new patient populations with significant comorbidities today. Data from all of the CoreValve studies was presented at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco.
The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study repo...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic TCT 2015 Source Type: news
Study: Edwards’ Sapien and Medtronic’s CoreValve outcomes are similar
A new study published in the Journal of the American College of Cardiology found that patients treated with Edwards Lifesciences‘s (NYSE:EW) and Medtronic‘s (NYSE:MDT) CoreValve showed similar results after 1 year.
The 241-patient trial examined high-risk patients with symptomatic severe aortic stenosis 1 year after being treated with either Edwards’s Sapien balloon expanding or Medtronic’ self-expanding transcatheter heart valve.
The rates of all-cause death and cardiovascular death were not statistically different between the groups, with a 3-5% difference between the 2 devices, according to the ...
Source: Mass Device - August 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Edwards Lifesciences medtronic Source Type: news
MassDevice.com +3 | The top 3 medtech stories for August 10, 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. NDC closes Interface Catheter buy, rebrands as Confluent
Nitinol Devices & Components said it closed its acquisition of Interface Catheter Solutions and announced it will rebrand the new combined company as Confluent Medical Technologies.
Confluent Medical will leverage both NDC and Interf...
Source: Mass Device - August 10, 2015 Category: Medical Equipment Authors: MassDevice Tags: Blog Plus 3 Source Type: news
TAVI: Study finds low stroke rates with Medtronic’s CoreValve
A clinical study of nearly 1,000 patients implanted with Medtronic‘s (NYSE:MDT) CoreValve replacement heart valve found a low rate of stroke out to 2 years.
The study, published last month in the Journal of the American College of Cardiology, evaluated patients for neurological events over 3 periods after the procedure to implant the CoreValve transcatheter aortic valve implant: Periprocedural (0 to 1 days); early (2 to 30 days); and late (31 to 730 days).
Results from the 996-patient trial, “The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic ...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Regulatory/Compliance CoreValve Inc. medtronic Source Type: news
UPDATE: FDA OKs new Sapien 3 valve from Edwards
UPDATED June 18, 2015, with details from Edwards and Leerink Partners.
The FDA said today that it approved Edwards Lifesciences‘s (NYSE:EW) Sapien 3 transcatheter heart valve for inoperable or high-risk patients with a narrowing in the heart’s aortic valve.
The approval was based on a 583-patient clinical study of patients who were at high risk for open heart surgery or who could not undergo the surgery due to excess risk, the federal watchdog said.
“Clinical data showed that the Sapien 3 transcatheter heart valve is superior to the 1st generation Sapien transcatheter heart valve, with significantly l...
Source: Mass Device - June 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Edwards Lifesciences Source Type: news
TAVI: Boston Scientific’s Lotus valve tops Medtronic’s CoreValve – study
Data from a study of Boston Scientific‘s (NYSE:BSX) Lotus Valve showed a greater device success rate than Medtronic‘s (NYSE:MDT) CoreValve in high-risk transcatheter aortic valve replacement patients.
The single-center, non-randomized study, published this month in the journal JACC: Cardiovascular Interventions, compared outcomes from 50 high-risk TAVI patients treated with the Lotus valve and 50 similar patients treated with Medtronic’s self-expanding CoreValve device.
Success rates were higher at 30 days in the Lotus group, at 84%, versus 64% with CoreValve, according to the study. These results...
Source: Mass Device - June 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific JACC: Cardiovascular Interventions medtronic Source Type: news
TAVI: Good early data for Keystone Heart’s TriGuard
Data from a trial of Keystone Heart‘s TriGuard anti-stroke device showed a lower rate of neurologic deficits after transcatheter aortic valve implantation, according to research presented last month at EuroPCR 2015 in Paris. The 85-patient Deflect 3 study found that TAVI patients treated with the Israeli company’s TriGuard, which is designed to allow blood to […]
The post TAVI: Good early data for Keystone Heart’s TriGuard appeared first on MassDevice.
Source: Mass Device - June 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Neurological Replacement Heart Valves Keystone Heart TAVI Source Type: news
