Investigators reported that cardiac survival of patients, who were implanted with the 21F CoreValve system in 2005 and 2006, was 77.9 percent at two years and 68 percent at four years; in other Medtronic news, company announces completing the acquisition of Peak Surgical Inc. and Salient Surgical Technologies Inc.
New data presented over the weekend at the European Society of Cardiology Congress 2011 show that Medtronic’s CoreValve transcatheter aortic valve replacement system maintained its structural integrity and led to positive clinical outcomes over four years. The study followed 50 patients—with an average age of 81 years—with native aortic valve disease who were implanted with the 21F CoreValve system in 2005 and 2006 at seven centers in Europe and Canada.
Investigators reported that cardiac survival was 77.9 percent at two years and 68 percent at four years. In addition, at four years, patients saw substantial improvement in heart failure symptoms. Eighty-seven percent were in NYHA Functional Class III or IV at the beginning of the study, but 61 percent had improved to Class 1 and 22 percent to Class II at four years, according to a company release. Valve performance was strong with no reported frame fractures or valve migrations.
“These results reinforce that CoreValve is a sound and stable valve that holds up to real-world use,” said Peter den Heijer, interventional cardiologist at Amphia Hospital Breda in the Netherlands and an investigator in the study. “Almost more important, however, is that these patients–most of whom were old and very sick at the time of enrollment–saw such positive outcomes, including dramatic improvements in the activity level they could withstand, despite being some of the first patients in the world to undergo TAVI.”
Since 2007, the CoreValve system has been implanted in patients in more than 40 countries, but is currently limited to investigational use in the U.S. The system is not approved in Canada and is available there through a special access program. In the U.S. CoreValve is being studied in a clinical trial that is expected to be completed next year.
In related news, Medtronic announced completing the acquisition of two privately-held companies, Peak Surgical Inc. and Salient Surgical Technologies Inc. Both of the companies are focused on advanced energy surgical technologies and will broaden Medtronic Surgical Technologies’ portfolio of innovative surgical products to meet customer and patient needs worldwide.
PEAK Surgical’s patented PlasmaBlade® cutting technology is cleared for use in a variety of settings, including Ear, Nose and Throat (ENT), plastic reconstructive and general surgical applications. The total value of the transaction is $120 million.
Salient Surgical Technologies’ patented TRANSCOLLATION® technology is cleared for use in a variety of surgical procedures including orthopaedic surgery, spine, open abdominal and thoracic procedures. The total value of the transaction is $525 million.