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.”

For more information: www.tandemheart.com

Related Content

Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
Overlay Init