News | August 20, 2021

FDA Grants Breakthrough Device Designation to Impella ECP

The device is the world’s smallest heart pump for percutaneous hemodynamic support and provides flow greater than 3.5 L/min

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s new Impella ECP expandable percutaneous heart pump. The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application.

August 20, 2021 – The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s new Impella ECP expandable percutaneous heart pump. The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application.

Impella ECP is the smallest heart pump in the world and the first to be compatible with small-bore access and closure techniques. It measures 9 French (3 mm) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min.

The FDA granted breakthrough device designation in part based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study. In granting the designation, the FDA determined Impella ECP meets the FDA’s stringent requirements for a breakthrough device.  

“This is yet another validation from the FDA of the clinical benefits of Impella technology and an affirmation of the innovative nature of Impella ECP which, due to its smaller vascular access size, has the potential to provide even safer procedures and be available to more patients who need hemodynamic support for coronary revascularization,” said Chuck Simonton, M.D., Abiomed’s chief medical officer.

In the United States, 440,000 patients annually are indicated and yet under-treated for high-risk PCI. Impella ECP’s size may enable more physicians to provide critical hemodynamic support to coronary artery disease patients who need it.  

First Patient Treated with Impella ECP

The first Impella ECP patient in the world was Robert Matthews, an 80-year-old retired auto worker from Detroit, a father of four, and grandfather of 11. For more than 20 years, Robert lived with heart disease and endured multiple procedures. In 2020, he was referred to Amir Kaki, M.D., an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit. Kaki discovered multiple blockages and poor heart function and identified Robert as an appropriate candidate for a protected PCI with Impella. Robert became the first patient in the world treated with Impella ECP when Kaki inserted the heart pump prior to opening blockages and placing stents. 

Two days later, Robert returned home, and his family and friends immediately noticed his renewed energy. Today, Robert is grateful for the cutting-edge technology that restored his quality of life.

The Impella ECP is an investigational device, limited by federal law to investigational use only.

For more information: www.abiomed.com

 

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