US-based medical device company CardiacAssist has obtained Class 4 medical device approval from Health Canada for its TandemHeart circulatory support platform.
The TandemHeart system is now licensed to provide up to 10 days of circulatory support in patients with reduced left ventricular function and patients with limited pre-operative/pre-procedure ejection fraction and/or with a high risk of post-operative/post-procedure low output syndrome.
CardiacAssist’s TandemHeart system can be implanted through a minimally-invasive procedure in the cardiac catheterisation lab or operating room by a skilled interventional cardiologist or cardiovascular surgeon.
The company claims that the TandemHeart system is the only percutaneous platform able to completely bypass the left ventricle. This is achieved through a transseptal access procedure to withdraw oxygenated blood from the left atrium and return it to the central arterial circulation.
This unique configuration enables the TandemHeart device to take over for the damaged native heart, while also allowing the patient’s left ventricle to rest and recover.
Peter Munk Cardiac Centre in Toronto Interventional Cardiology director Dr Vladimir Dzavik noted that the TandemHeart platform offers a new and unique opportunity for Canadian physicians to effectively treat patients in severe cardiac distress.
"We are very excited to be able to provide this best-in-class technology to patients facing a condition that has been a significant clinical challenge for decades, and we look forward participating in the development of new clinical science with a focus on improving survival rates," Dr Dzavik added.