Latest Heart valve Stories

CHICAGO, Dec. 20, 2012 /PRNewswire/ - The FDA 510(k) process is a complex process allowing Companies to apply or to not apply for a new 510(k) application. The Myxo File: Part I and Part II  just released through Kindle Direct Publishing will provide documents from the FDA compliance review and the letters sent by members of Congress and the White House including letters from The Honorable Senator Richard Lugar from Indiana and The Honorable Senator John McCain from Arizona on...

Results of PARTNER Cohort B trial presented at TCT 2012 A study found that transcatheter aortic valve replacement (TAVR) yielded lower mortality rates after three years compared with medical therapy in patients deemed to be ineligible for conventional aortic valve surgery. Results of the PARTNER Cohort B trial were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the...

BETHLEHEM, Pa., Oct. 22, 2012 /PRNewswire/ -- Micro Interventional Devices, Inc.(TM) (MID), an emerging cardiovascular medical device company, announced today that the first patient has been treated using its self-sealing, cardiac access and closure technology, Permaseal(TM). The patient is the first to be enrolled in the company's STASIS clinical trial that has commenced in Europe. The first STASIS case was performed by Principal Investigator Professor Dr. med. Rudiger Lange,...

More Patients Now Will Be Eligible for TAVR Procedure. CLEARWATER, Fla., Oct. 19, 2012 /PRNewswire-USNewswire/ -- Morton Plant Hospital is the first hospital in the Tampa Bay area to perform Transcatheter Aortic Valve Replacement (TAVR) by the transapical approach. Transapical TAVR is the latest FDA-approved treatment for people suffering from severe aortic stenosis. Aortic stenosis is a narrowing of the aortic valve of the heart, which causes the valve to fail to open...

TUCSON, Ariz., Oct. 18, 2012 /PRNewswire/ -- SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that San Raffaele Hospital in Milan, Italy, has discharged its first patient to receive the SynCardia temporary Total Artificial Heart. On Sept. 7, 55-year-old Marco Fumagalli left the hospital to wait for a matching donor heart at home using the Freedom® portable...

NATICK, Mass., Oct. 10, 2012 /PRNewswire/ -- Boston Scientific (NYSE: BSX) has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus(TM) Valve System in up to 120 patients with severe aortic valve disease. This international, multi-center study includes 15 sites in Australia, France, Germany and the United Kingdom. The Lotus Valve System is the first transcatheter aortic valve replacement (TAVR) device of its kind that is...

Prosthetics can be enlarged as children grow, reducing need for future replacement surgeries BOSTON, Oct. 3, 2012 /PRNewswire-USNewswire/ -- Surgeons at Boston Children's Hospital have successfully implanted a modified version of an expandable prosthetic heart valve in several children with mitral valve disease. Unlike traditional prosthetic valves that have a fixed diameter, the expandable valve can be enlarged as a child grows, thus potentially avoiding the repeat valve...

KIRKLAND, Wash., Sept. 28, 2012 /PRNewswire/ --Cardiac Dimensions(®),( )Inc. today announced that it has initiated its commercial efforts in Europe, treating the first patients with its CARILLON® Mitral Contour System® under its Conformite Europeenne (CE) Mark approval. The CARILLON system is a novel, minimally invasive therapy for treating heart patients suffering from functional mitral regurgitation (FMR). An estimated 70 percent of the 20 million people worldwide with heart...

TUCSON, Ariz., Sept. 20, 2012 /PRNewswire/ -- SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that the first patient to receive the SynCardia temporary Total Artificial Heart at Ankara University Heart Center in Turkey has been discharged from the hospital. The patient, 47-year-old Arif Sahin, is currently waiting for a matching donor heart with his family...

--"Encouraging" Short-Term Data from Innovative Product to Treat Mitral Regurgitation Using Transcatheter Approach-- --Chronic Animal Studies Underway in Preparation for Potential First Human Implantations in 2013-- TSX Venture Exchange: NVC VANCOUVER, Sept. 18, 2012 /PRNewswire/ - Neovasc Inc. (TSXV: NVC) today announced that acute results from preclinical studies of its Tiara(TM )valve for the transcatheter treatment of mitral regurgitation were published in the...