Medtronic wins EU nod for less-invasive HVAD implant procedure

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a less-invasive implant procedure for the HVAD system left ventricular assist device it acquired along with HeartWare in August. The new implantation procedure uses a smaller incision than the previously cleared procedure, Fridley, Minn.-based Medtronic said, potentially lessening bleeding and related blood transfusions. The newly cleared procedure could potentially reduce the development of right heart failure and could lead to shorter hospital stays, along with allowing for the area around the heart to remain largely intact to potentially preserve the sternum for future procedures or heart transplants, the company said. “The HVAD System’s small size makes it well-suited for routine thoracotomy implantation. This less-invasive implant procedure potentially enables faster patient recovery compared to the traditional approach, which may help improve patient outcomes,” Dr. Jan Schmitto of Germany’s Hannover Medical School, who helped develop the new procedure, said in prepared remarks. The company said it is currently performing an ongoing study of the thoracotomy HVAD procedure in Canada and the U.S., where it does not currently have approval. “The HVAD System is the only full-support, centrifugal LVAD approved in Europe for thoracotomy implantation, providing clinicians with greater freedom to choose the best surgical technique for each patient. CE Mark for the tho...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance Surgical HeartWare International Inc. Medtronic Source Type: news