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.
Boston Scientific has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus Valve System in up to 120 patients with severe aortic valve disease. Benzinga