CardiacAssist, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its PROTEK Duo veno‐venous cannula. The PROTEK Duo is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support (ECLS) procedures.
The PROTEK Duo cannula is designed to address two major roadblocks that have prevented VV ECLS therapy from becoming a new standard of care: the difficulty of initiating and maintaining a patient on VV ECLS support, and suboptimal gas exchange rates with currently available devices. Insertion of the PROTEK Duo cannula can be performed through a minimally‐invasive percutaneous procedure, and patient management is simplified by combining with the lightweight and compact TandemHeart pump, which can be placed directly on the patient. The TandemHeart platform is designed to simplify patient ambulation and enable freedom of movement not possible with mechanical ventilation or any alternative ECLS device.
“The percutaneous internal jugular approach of this promising new technology will give us the ability to minimize the morbidity usually associated with central ECLS cannulation. By optimizing patient mobility, we also expect to reduce the long-term negative effects of severe deconditioning. The extracorporeal life support community welcomes these innovative medical devices designed to help physicians improve patient outcomes,” noted Dr. Jose P. Garcia, Surgical Director of Cardiothoracic Transplantation and the Artificial Heart & Lung Program at Massachusetts General Hospital in Boston, MA.