CardiacAssist Receives Canadian Approval for Protek Duo Veno-Venous Cannula

CardiacAssist Inc. has received a Class 2 medical device license from Health Canada for its new Protek Duo veno-venous cannula. The Protek Duo is licensed for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

Approximately 18,000 people in Canada are diagnosed with Acute Respiratory Distress Syndrome (ARDS) every year. Despite receiving therapy with mechanical ventilation, which is widely considered the standard of care, almost half of those diagnosed with ARDS will die as a result of the disease, according to industry figures. Veno-venous extracorporeal life support (VV ECLS) is an emerging therapy designed to provide a higher level of support by infusing oxygen directly into the blood using an oxygenator, a medical device that acts as an artificial lung. In one large randomized, controlled clinical trial of 180 adult ARDS patients, the use of advanced VV ECLS therapy was shown to improve the rate of survival free of disability by 34 percent versus conventional management with mechanical ventilation.

The Protek Duo cannula is designed to address two major roadblocks that previously have kept VV ECLS therapy from becoming a new standard of care: the difficulty of initiating and maintaining a patient on VV ECLS support versus mechanical ventilation, 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 TandemHeart pump, which can be placed directly on the patient. The TandemHeart platform recently received a Class 4 medical device license from Health Canada for up to 10 days of circulatory support and is designed to simplify patient ambulation and enable freedom of movement not possible with mechanical ventilation or any alternative ECLS device. Additionally, the PROTEK Duo cannula is designed for omnidirectional flow and can bypass the right ventricle of the heart by directing flow from the patient’s right atrium to the pulmonary artery, optimizing gas exchange and simultaneously reducing stress on the right side of the heart.

“The Canadian launch of the Protek Duo cannula is taking TandemHeart into new territory. We are now working on new innovations to help both heart and respiratory failure patients, with even more new products in the pipeline coming right behind Protek Duo. Our goal will be to keep respiratory patients moving while continuing our mission to advance the treatment of heart failure,” said John Marous, president/CEO of CardiacAssist.

CardiacAssist is a privately-held medical technology company headquartered in Pittsburgh, Pa., that developed the world’s first U.S. Food and Drug Administration-cleared and CE-marked short-term extracorporeal circulatory support platform designed for both interventional cardiologists and cardiac surgeons.