Transcatheter aortic heart valve replacement is “recommended” for patients with severe symptomatic valve stenosis who have a “prohibitive” risk from open surgery, while the procedure is a “reasonable alternative” to surgery in patients at high risk for an open procedure, cardiology and surgical societies conclude in a consensus document issued Jan. 31. Five clinical groups jointly released the document about two months after the procedure first become available outside of clinical trials in the U.S. with FDA approval of Edwards Lifesciences’ Sapien valve. (See Also see "Edwards Wins Approval For Sapien Just In Time For TCT" - Medtech Insight, 7 November, 2011..) The approval only applies to the former “prohibitive” population, while Edwards still seeks FDA go-ahead for high-risk surgical patients based on largely positive data from its PARTNER trial. The document also emphasizes very careful patient selection, the importance of a team-based approach to the procedure, strict training and credentialing standards for hospitals and clinicians, and registry-based data collection.
Orthopedic device maker raised $89 million in a “Series E” private placement round completed in 2011, the firm announced Jan. 30. Privately held ConforMIS Inc. notes that it has...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?
