A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
St. Jude Medical has chosen physicians to lead the clinical trial for the company’s transcatheter aortic valve. The trial will study the safety and efficacy of the valve in patients with severe aortic stenosis. The trial will evaluate two delivery systems, the transfemoral and the transapical systems, both of which are designed for easier deployment and retrieval of the valve.