Direct Flow, a medical device manufacturer based in Santa Rosa, California, announced that it had received CE Mark clearance from the European Union for its transcather aortic heart valve with a transfemoral delivery system.
According to a press release by the company, the Medical Transcatheter Aortic Valve System is designed to prevent or reduce aortic regurgitation through through assessment, repositioning and post-deployment valve retrieval in the native valve annulus. The TAVR system comprises a double-ringed design to create a durable and tight seal around the annulus. In addition, the device is designed to improve long-term patient survival rates by eliminating issues found in currently-available commercial valves.
Two different valve sizes (25 mm and 27 mm) will be available in Europe immediately. Both valve systems are designed to be delivered by an 18 French system.
Professor Joachim Schofer is the chief MD at the Hamburg Medical Care Center in Germany. Prof. Schofer was the co-principal investigator in the Discover trial. In prepared remarks, he said, “Its novel design enables us to fully assess outcomes and adjust or retrieve the valve at any time during the procedure, without creating hemodynamic stress for the patient.” He continued, “This keeps the procedure calm throughout. Delivery is also easy, as the flexible, low-profile design has enabled me to navigate vessels as small as 5.2 mm without vascular complications.”