News | April 14, 2014

CardiacAssist Receives Health Canada Approval for TandemHeart Circulatory Support Platform

Percutaneous left ventricular bypass for temporary circulatory support durations up to 10 days now available to Canadian patients

April 14, 2014 — CardiacAssist announced it has received a Class 4 medical device license for its TandemHeart system from Health Canada. The TandemHeart system is now licensed to provide up to 10 days of circulatory support in:

  • Patients with reduced left ventricular function (e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction [MI] or from non-ischemic causes); and
  • Patients with limited pre-operative/pre-procedure ejection fraction (EF) and/or with a high risk of post-operative/post-procedure low output syndrome.

“The TandemHeart platform offers a new and unique opportunity for Canadian physicians to effectively treat patients in severe cardiac distress,” said Vladimír Džavík, M.D., FACC, director of interventional cardiology at the Peter Munk Cardiac Center in Toronto. “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.”

When patients experience an acute cardiovascular event, such as a heart attack, the capability of the heart muscle to pump blood is often significantly reduced. If left untreated, the result is a reduction of blood flow to the vital organs that could eventually lead to death. Hospitals with advanced cardiac care capability may treat these patients by initiating circulatory support to augment the flow of blood through the patient’s body. Several alternative circulatory support therapies are available, but the TandemHeart platform provides a unique therapeutic option for Canadian patients presenting to the hospital in severe cardiac distress.

The TandemHeart system can be implanted using a minimally invasive procedure in the cardiac catheterization lab or operating room (OR) by a skilled interventional cardiologist or cardiovascular surgeon. It is the only percutaneous platform able to completely bypass the left ventricle, the pumping chamber of the heart most commonly affected by a heart attack. This is accomplished through a transseptal access procedure to withdraw oxygenated blood from the left atrium, a holding chamber for the left ventricle, 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.

“During the course of the approval process we have been very thankful for the guidance of Dr. Vladimír Džavík and several other thought leaders in the cardiovascular space who are committed to bringing the benefits of TandemHeart to patients throughout Canada,” said John Marous, president and CEO of CardiacAssist. “We and all of our physician partners in the Canadian community are very excited to finally be able to bring this technology to market while pushing new frontiers of cardiovascular medicine through investment in clinical science in Canada.”

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