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Medtronic Hopes to Expand Cardio Biz
September 16, 2014
3 Min Read
Medtech giants jockeyed for attention to their coronary catheterization products at the 26th Transcatheter Cardiovascular Therapeutics (TCT) meeting held this week in Washington, D.C., according to a report on bidnessetc.com and company announcements.Minneapolis-based Medtronic had lots to talk about. The Food and Drug Administration gave 510(k) approval last week to its NC Euphora Noncompliant Balloon Dilatation Catheter for use in heart replacement surgeries. The company received the CE Mark to market the device in Europe in May.
Among the new products launched by Medtronic this year is the the Reveal LINQ, the smallest insertable cardiac monitor now available.
The NC Euphora is inflated with high pressure to ensure that a drug-eluting stent inserted to reopen a narrowed artery is fully expanded, aiding transfer of the drug to the artery wall, according to a company statement.Medtronic also used the conference to tout the results of a study of 305 high-risk patients who received its CoreValve transcatheter aortic valve replacement (TAVR) device. TAVR is indicated for patients who suffer from narrowing of the aortic valve, or aortic stenosis, according to another company statement. It is less invasive than open-heart surgery to remove and replace an older valve. The company recommends it for patients who cannot withstand open-heart surgery."Consistent with the positive one-year clinical results, all-cause mortality (36.5 percent) and major stroke (5.1 percent) at two years were low for this extreme risk cohort," the company said.After two years, the CoreValue demonstrated good blood flow performance, consistent with one-month and one-year rates, it noted. The FDA approved the CoreValve on January 17. A Zacks Equity Research blog reported that Medtronic has evidently captured almost 40% of the U.S. market in just two quarters after launching CoreValve in the U.S.Not to be outdone, Edwards Lifesciences, Medtronic's primary competitor in this space, presented five-year trial data for its Sapien transcatheter heart valve at the conference. Inoperable patients who received the company's Sapien heart valve experienced sustained improvements in heart function and fewer repeat hospitalizations, Edwards (Irvine, CA) said in a statement.St. Jude Medical (Little Canada, MN) and Boston Scientific Corp. also presented data on their less-invasive heart valves at TCT. However, Medtronic scooped both companies, launching the first U.S. trials for its Evolut R transcatheters on Wednesday, Zacks reported. In other news this week, Medtronic announced the launch of its external, wire-free, adhesive heart monitor, the SEEQ Mobile Cardiac Telemetry System. Patients can wear the device for up to 30 days - even in the shower - to help detect and diagnose the cause of irregular heartbeats. Medtronic announced it was acquiring Corventis, Inc., which developed the technology, in June 2014.The SEEQ system automatically sends cardiac data to the Medtronic Monitoring Center, where cardiographic technicians monitor data around the clock. Patients may also use a trigger button to alert the monitoring center to symptoms, the company said in a statement.Minneapolis-based Preventice, which Qmed.com reported last week had merged with eCardio (Houston, TX), also makes a patch-based wireless heart monitoring system, the BodyGuardian. Worn on the chest, the BodyGuardian delivers information to a dedicated Samsung smart phone that conveys it to the patient's physician.Topping it all off, Medtronic this week was named one of the world's leading companies for sustainability on the Dow Jones Sustainability World Index for the fourth year in a row, according to a Thomson Reuters report. Criteria include economic performance, environmental stewardship and social responsibility.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
Nancy Crotti is a contributor to Qmed and MPMN.
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