Magenta Medical

Magenta Medical announced today that it completed enrollment for the early feasibility study of its Elevate heart pump device.

The FDA-approved study evaluates the percutaneous left ventricular assist device (pLVAD) for high-risk percutaneous coronary intervention (HR-PCI). Investigators enrolled and successfully treated 15 study patients. Treatments took place at Mount Sinai Hospital, St. Francis Hospital and Heart Center and North Shore University Hospital.

Magenta won FDA approval to evaluate the safety and feasibility of Elevate in providing temporary mechanical support in HR-PCI procedures. It constitutes the first step in a clinical program aimed at securing approval for Elevate — the world’s smallest heart pump — in the U.S.

Dr. Samin Sharma, director of interventional cardiology at Mount Sinai, performed the first U.S. procedure. Sharma cited “three cardinal features” of Elevate — small insertion profile, ease of use and high pu…

Miniature heart pump developer Magenta Medical announced today that it raised $55 million in a financing round led by OrbiMed.

Existing investors New Enterprise Associates, Pitango VC and ALIVE – Israel HealthTech Fund all participated, too.

Magenta said it intends to use proceeds to advance its clinical programs in the U.S. toward a first FDA approval.

The Kadima, Israel–based company develops a percutaneous left ventricular assist device (LVAD). The powerful heart pump is initially folded, inserted through the groin using a small puncture, and expanded to activate inside the left ventricle. The clinical circumstances of the patient determine how the flow of the pump adjusts. This ranges up to the entire cardiac output, allowing the heart to rest and the patient to recover.

Magenta said that, once approved, physicians can use the device to treat mechanical circulatory support (MCS) patients. This could eliminate the need to escalate therapy…