Danvers cardiac device maker Abiomed Inc. has won federal approval to sell a new heart pump that is less invasive and delivers greater blood flow than a similar model it now markets.
Abiomed said Monday that its Impella CP pump was approved by the Food and Drug Administration under the agency’s 510(k) clearance process, which allows companies to skip clinical testing of medical devices that are considered “substantially equivalent” to those already on the market.
In the case of the Impella CP — now available in European countries — Abiomed is rolling out a more powerful version of its Impella 2.5 pump, delivering 4 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 used only for short periods.
Both of the Abiomed pumps are smaller than competing devices and are inserted through the leg by interventional cardiologists in catheterization labs. The technology is favored by many doctors over the surgical “cutdowns” through the shoulder used to insert other heart pumps.
Abiomed chief executive Michael R. Minogue said in a statement that the new pump would expand the company’s product portfolio and be “a significant tool in helping more patients.” Minogue was not available to discuss the FDA clearance, a company spokeswoman said.
With many investors already anticipating regulatory approval of the Impella CP, which had been widely expected by the end of the summer, Abiomed shares edged down 64 cents to $20.36 on Monday, a decline of more than 3 percent on the Nasdaq stock exchange.
But medical-device analyst Greg Simpson, senior vice president at investment firm Wunderlich Securities Inc. in St. Louis, called the new product a “game-changer.” He said it can be expected to boost Abiomed’s share in the more than $1 billion-a-year US market for heart pumps as more physicians move away from balloon pumps. Those devices are connected to a machine and often require surgery.
“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.”
The company is hoping its approach of inserting pumps percutaneously — by puncturing the skin with a needle catheter — will give it a competitive advantage over rivals such as Germany’s Maquet Medical Systems and Teleflex Medical of North Carolina, which market balloon pumps.
Impella pumps are inserted through the patient’s leg in the femoral artery, which feeds into the aorta. From there, the pumps hook into the left ventricle of the heart, pulling the blood out, spinning it into the aorta, and pumping it into the rest of the patient’s body.