Abiomed Updates Heart Pump

Danvers, Mass.-based Abiomed Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new heart pump, Impella CP (cardiac power). It is a more powerful version of the company’s Impella 2.5, delivering four liters of blood per minute rather than 2.5 liters for patients who have had heart attacks or are undergoing stent procedures.

The device is meant to be used only for short periods. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5. Both of the Abiomed pumps reportedly are smaller than competing devices and are inserted through the leg by interventional cardiologists in catheterization labs. The company claims this technology is favored by many doctors over the surgical “cutdowns” through the shoulder used to insert other heart pumps. The Impella pump enters the body through the femoral artery, which feeds into the aorta. From there, the pumps hook into the left ventricle of the heart, redirecting the blood to the aorta, and pumping it into the rest of the patient’s body.

“The clinical community has been anxiously anticipating the arrival of this new Impella pump,” said John Lasala M.D., medical director of Washington University School of Medicine in St. Louis, Missouri. “The Impella CP promises a substantial amount of cardiac power, can be inserted quickly, and is ideal for patients that require more hemodynamic support. It is exciting for physicians to be able to provide this type of percutaneous support that represents approximately 80 percent of what a healthy heart can pump each minute.”

“We are very pleased to announce the availability of the new Impella CP and we expect this to be a significant tool in helping more patients,” said Michael R. Minogue, chairman, president and CEO of Abiomed.

Impella CP’s clearance from the FDA was based on its substantial equivalence to the Impella 2.5. The device received CE Mark approval to market the device in Europe in April this year.

Greg Simpson, medical device analyst and senior vice president at investment firm Wunderlich Securities Inc. in Memphis, Tenn., told The Boston Globe that the product is a “game changer.” He also said it can be expected to boost Abiomed’s share in the more than $1 billion-a-year U.S. market for heart pumps as more physicians move away from balloon pumps. Balloon pump procedures usually are more invasive.

“Abiomed keeps expanding and extending the product line,” Simpson said. “And by raising the blood flow, the Impella CP provides doctors with an option to treat more patients who previously had to use more invasive devices or older devices in the market.”

Abiomed provides devices for circulatory support. The company has three FDA studies—Protect I, Recover I, and Protect II—currently published on Impella.