Ocala Health
April 10, 2017

Impella is only treatment determined safe and effective for elective and emergent high-risk heart failure patients

Ocala, FL - Cardiologists at Ocala Regional Medical Center conducted the first procedure at the hospital using Impella®, the world's smallest heart pump, the hospital announced today. Designed to provide minimally-invasive, temporary support for patients with heart failure, technology like Impella will allow Ocala Regional Medical Center to provide more comprehensive and advanced care options to patients in Marion County and its surrounding communities with advanced coronary disease. Impella allows patients to recover their native heart, which is ideal for quality of life, and has the potential to save costs in the healthcare system.

Impella is the only FDA-approved percutaneous hemodynamic support device determined to be safe and effective for the treatment of elective and emergent high risk patients, and recently received expanded approval from the United States Food and Drug Administration (FDA).

The Impella device is placed into the heart through a peripheral artery and will support the heart circulatory system during an elective high-risk percutaneous coronary intervention (PCI) procedure, called Protected PCI. It is also approved to treat cardiogenic shock, a condition where the heart fails to pump enough blood to vital organs and they begin to shut down. Cardiogenic shock typically happens during or after a heart attack. Impella works for the heart, allowing it to rest and recover while doctors place stents in the patient's arteries to unblock them and increase blood flow.

"Ocala Health is recognized as a leading provider of cardiovascular care in the region," said Michelle Hodges, Cardiovascular Service Line Administrator, Ocala Health. "Adding the Impella heart pump technology to our cardiovascular offerings means we can provide a new option to patients who may have been turned down for heart surgery or whose hearts are too weak to pump on their own after a heart attack."

"The Impella technology will be helpful for us during high-risk angioplasty (ballooning) and/or stenting, or for patients experiencing an acute heart attack and cardiogenic shock," says Prem Singh, MD, FACC, FSCAI, Cardiac Catheterization Laboratory Medical Director, Ocala Health. "The Impella is a miniaturized pump with a motor. It is inserted in the heart to pump blood out of the heart. It temporarily supplements the heart's pumping ability, allowing the heart to rest and recover, as normal blood flow is re-established. It can pump 2.5 to 3.5 liters of blood per minute--more than half of the body's normal capacity. This new minimally invasive technology furthers our commitment to provide comprehensive treatment options for high-risk patients."

Ocala Regional Medical Center joins more than 1,000 hospitals in the United States that use Impella products. More than 50,000 patients in the United States have benefited from Impella support. The Impella platform of products were developed by Abiomed Inc., based in Danvers, Massachusetts.

About Impella

The Impella products offer the unique ability to stabilize the patient's hemodynamics and unload the heart, which allows the muscle time to rest and potentially recover its native function. The Impella 2.5 heart pump received FDA Premarket Approval (PMA) for high risk PCI in March 2015. The Impella 2.5, Impella CP, and Impella 5.0 heart pumps received FDA PMA for the treatment of cardiogenic shock following an acute myocardial infarction/heart attack or after heart surgery in April 2016. These are the first and only percutaneous ventricular support devices that are FDA-approved as safe and effective for the cardiogenic shock indication. The Impella product portfolio, which is comprised of the Impella 2.5, Impella CP, Impella 5.0, Impella LD, and Impella RP devices, has supported over 45,000 patients in the United States.