Abiomed Receives FDA HDE Approval for the Impella RP

DANVERS, Mass., Jan. 27, 2015 (GLOBE NEWSWIRE) -- Abiomed Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that the Impella RP® (Right Percutaneous) System has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE). This innovative medical device is the first percutaneous single access heart pump designed for right heart support to receive FDA approval. Abiomed completed the HDE submission for the Impella RP in September 2014 following the completion of the RECOVER RIGHT study.

Delivered through a catheter requiring only a small hole in the leg, the Impella RP is FDA indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. These patients lack blood flow from the right side of their hearts. The Impella RP is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides up to four liters per minute of hemodynamic support.

"The Impella RP represents a huge step forward in offering right side support using a minimally invasive platform and has the potential to transform interventional cardiology and cardiac surgery today. With the ability to place this device percutaneously on the right side, physicians can now treat acute right sided heart failure minimally invasively and quickly," said Mark Anderson, M.D., co-principal investigator for the RECOVER RIGHT trial and chair of the division of cardiothoracic surgery at Einstein Medical Center.

"We are pleased to receive the HDE approval for the Impella RP. This is a milestone for the company as well as the interventional community in providing support for patients with right sided heart failure. Our Impella platform now has the ability to offer support for both sides of the heart, offering more treatment options for patients and hospitals," said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.

There will be a controlled launch of the Impella RP in the U.S. after each site completes in-house training at Abiomed. This rigorous training will incorporate members of the heart team, including the interventional cardiologist, cardiac surgeon, heart failure cardiologist and lead nurse.  

As part of the HDE approval, Abiomed is required to conduct two post approval studies (PAS) for the RECOVER RIGHT. One includes an adult patient population of 30 patients and the other, a pediatric patient population for a maximum of 15 patients (larger patients &#60 18 years of age with RVF.) These studies will be conducted to monitor the post-market safety and probable benefit of the Impella RP device. Both studies will be a single-arm multicenter studies that will follow the respective patients at 30 and 180 days post device explant.

RECOVER RIGHT Study Results

RECOVER RIGHT was an FDA-approved, prospective, multicenter, single arm study designed to evaluate the safety and probable benefit of the Impella RP in patients with right ventricular failure (RVF) refractory to medical treatment and deemed to require hemodynamic support.

The 30 patients enrolled in the RECOVER RIGHT trial were categorized into two patient cohorts. Cohort A included patients who developed RVF within 48 hours after implantation of a left ventricular assist device (LVAD). Cohort B examined patients who developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction (AMI) shock. The primary endpoint was patient survival at 30 days, hospital discharge, or bridge to the next therapy.

The clinical trial results from RECOVER RIGHT were announced in October 2014 at the annual Transcatheter Cardiovascular Therapeutics (TCT) 2014 scientific meeting in Washington, DC. Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83.3% and Cohort B showed a 58.3% survival rate at 30 days.

In May 2014, Abiomed received approval for a Continuous Access Protocol (CAP) from the Food & Drug Administration (FDA) for RECOVER RIGHT.

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, statements regarding the controlled launch of Impella RP and related training of medical professionals relating to such launch. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will," and other words and terms of similar meaning. These forward-looking statements include all matters that are not historical facts. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly update or revise these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or otherwise, unless otherwise required by law.