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Cardiac Assist’s Emergency Cannula Receives CE Mark

Protek Duo can be used in conjunction with the company’s TandemHeart life support system.

By: Michael Barbella

Managing Editor

CardiacAssist Inc.’s Protek Duo emergency cannula has been granted CE Mark approval.

The device uses a minimally invasive percutaneous process to administer veno-venous extracorporeal life support for patients with acute respiratory disease syndrome. The cannula is inserted into the jugular vein and can both drain and re-infuse blood, the company said.

According to estimates from the National Heart, Lung and Blood Institute (NHLBI), approximately 190,000 Americans are affected by Acute Respiratory Distress Syndrome (ARDS) every year.  Despite receiving therapy with mechanical ventilation, which is widely considered the standard of care, approximately 40 percent of patients diagnosed with ARDS will die as a result of the disease. Veno-venous extracorporeal life support (VVECLS) 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 a clinical trial of 180 ARDS patients, VV ECLS therapy demonstrated a 31 percent reduction in patient death and disability when evaluated against the standard of care, the devicemaker claimed in a news release.

Health professionals can use the Protek Duo in conjunction with Cardiac Assist’s TandemHeart life support system, which provides up to 30 days of circulatory support, the company said.

Cardiac Assist received U.S. Food and Drug Administration (FDA) approval for the Protek Duo in August 2014.

In May 2014, the FDA issued a warning letter against Cardiac Assist, claiming the devicemaker did not report the death of a patient using the TandemHeart pump. The FDA deemed the company’s response sufficient and the matter was resolved.

CardiacAssist Inc. is a Pittsburgh, Pa.-based company founded in 1996 that develops, manufactures and markets circulatory support and other cardiovascular systems for cardiologists and cardiac surgeons.

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