Healthcare Industry News:  circulatory support 

Devices Cardiology FDA

 News Release - July 11, 2006

FDA Approves Abiomed's New Integrated Off-Pump Cannula

New Cannula to Standardize and Enhance Ventricular Assist Device Implantations

DANVERS, Mass.--(HSMN NewsFeed)--July 11, 2006--Abiomed, Inc. (NASDAQ: ABMD ) today announced U.S. Food and Drug Administration (FDA) approval of its Premarket Approval Application (PMA) supplement for the Company's new integrated cannula system. The new cannula (previously referred to as "minimally invasive cannula") has the potential for use off-pump with minimally invasive procedures and is designed to integrate with Abiomed's AB5000(TM) and BVS® 5000 circulatory support Systems. The new cannula system is easier to implant and explant and is expected to standardize surgical procedures for acute heart failure patients.

Abiomed's new cannula system provides an enhanced benefit since patients will not require a second sternotomy during off-pump explantations. Off-pump (also called beating heart) techniques provide potential patient benefits of a shorter hospital stay and recovery time, less bleeding, less potential for infection, and less trauma. The new cannula system consists of a 42 French cannula, surgical sewing cuff and an inline connector for precise implantation and reduced blood loss for patients in acute heart failure.

"This new cannula system offers cardiovascular surgeons a standardized and efficient circulatory support procedure for use with patients in acute heart failure," said Daniel Raess, M.D., F.A.C.C., F.A.C.S., Medical Advisor at Abiomed. "The device makes for easier off-pump implantations, minimizes damage to the heart muscle and blood, and allows for easier explant of circulatory support once the native function of the patient's heart has returned."

"As we have developed our open-heart programs, and focused on AMI patients, our users requested easier and quicker methods to implant the cannula without requiring the support of a heart lung machine, and the option to remove the cannula without requiring a second sternotomy for patients who recover. As we simplify the implantation and explantation process, we make our recovery VADs more likely to be used as the standard of care for cardiogenic shock at all surgery centers," said Michael R. Minogue, Chairman, CEO and President of Abiomed.

Abiomed's ventricular assist devices (VADs) are the only devices approved for all potentially recoverable indications. To date, more than 8,000 patients worldwide have been supported with these devices. Patients who have recovered included those suffering from cardiogenic shock resulting from myocardial infarction, myocarditis, postpartum cardiomyopathy, ventricular septal defect, refractory arrhythmias, failed heart transplants, right ventricular assistance with implantable Left VAD (LVAD), and postcardiotomy cardiogenic shock (PCCS). Abiomed's devices encourage recovery, and are easier to implant, utilizing cannula inserted through a small incision, rather than more traumatic bridge-to-transplant devices that core the ventricles. The new cannula technology may be used with these patients as they are provided circulatory support.

ABOUT ABIOMED'S NEW CANNULA

The new cannula system is a unique apical cannulation system designed to simplify and minimize blood loss during implantation and explantation. A key feature is a sliding seal that helps to control bleeding during procedures.

During surgery, the surgical felt patch is trimmed to size and sutured to the heart wall at the desired location. A special proprietary tool makes an incision at the heart wall through the center of the graft. Bleeding is controlled while the cannula is introduced into the graft, across the incision site, and adjusted to the desired depth. The base of the graft is secured to the cannula using umbilical tapes or heavy gauge silk ties. During explantation, the tapes or ties are removed, the cannula is withdrawn and the graft is sewn over or stapled to seal the site.

In addition to the new integrated off-pump cannula, Abiomed offers a wide range of cannula options, including:
  • 32 French Malleable, Ventricular Atrial
  • 42 French Malleable, Ventricular Atrial
  • 32 French Malleable, Short Apical
  • 42 French Malleable, Short Apical
  • 10mm Hemashield® Arterial Cannula
ABOUT ABIOMED

Based in Danvers, Massachusetts, ABIOMED, Inc. is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. ABIOMED currently manufactures and sells the AB5000(TM) circulatory support System and the BVS® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, ABIOMED offers the IMPELLA® RECOVER® minimally invasive cardiovascular support systems under CE Mark approval. The IMPELLA® 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other IMPELLA devices are not yet available for sale in the United States. The Company's AbioCor® Implantable Replacement Heart was the subject of an initial clinical trial under an Investigational Device Exemption from the United States Food and Drug Administration. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. 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, and future opportunities. 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, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, 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 Annual Report filed on Form 10-K. 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 release the results of any revisions to 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.


Source: Abiomed

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