Abiomed Inc., a Danvers company that has built a growing franchise in minimally invasive heart pumps, on Tuesday won a federal nod to sell the first pump for right-side heart support in the United States.
Food and Drug Administration regulators approved Abiomed’s application to market the Impella RP, a system delivered through a catheter requiring a small hole in the leg. The pump is then extended through the femoral vein into the pulmonary artery.
The pump is designed to give the minority of heart patients lacking blood flow from the right side of their hearts the pressure needed to compensate for right heart failure. Most of those patients currently require massive drug therapy or surgical procedures.
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“It’s a lifesaving product, and it supports the Abiomed portfolio,” chief executive Michael R. Minogue said in an interview Tuesday. “Our goal is to be the standard of care for [minimally invasive] systems. In order to treat all the patients, we have to provide support for both the left and the right sides of the heart.”
Abiomed currently sells a suite of similar Impella pumps focusing on the larger population of patients – an estimated 100,000 a year in the United States — needing support for the left side of their hearts. That market is projected at $2 billion a year globally, much of it now dominated by older technology inflatable balloon pumps.
The list price for the new Impella RP is expected to be between $20,000 and $25,000, according to the company. Abiomed’s devices for left-side heart support sell for an average of $24,000.
Abiomed, which has registered 21 straight quarters of year-over-year revenue growth on the strength of its Impella line, applied for FDA approval of its right-side Impella RP in September. The application was made under the agency’s humanitarian device exemption requiring makers to show safety and probable benefit in a population of very sick patients.
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While the FDA initially approved the Impella RP for a subset of only about 4,000 patients based on the results of a clinical study that enrolled 30 patients, Abiomed plans follow-on testing that would expand the number of patients served by its pump over time. The device eventually would target a US market projected at $100 million. It won European Union approval a year ago.
Dr. Mark Anderson, co-principal investigator in the Impella RP clinical study and chairman of the cardiac surgery division at Einstein Medical Center in Philadelphia, said in a statement that the minimally-invasive technique “has the potential to transform interventional cardiology and cardiac surgery today.”
The pump can provide up to four liters per minute for as long as two weeks in patients with acute right heart failure. In most cases, the right side of the heart recovered in clinical studies and patients were able to be weaned off the devices.
Abiomed, founded in 1981, has nearly 600 employees worldwide, including about 250 in Danvers. It has manufacturing plants in Danvers and in Aachen, Germany, and it recently opened a sales office in Japan.
Robert Weisman can be reached at robert.weisman@globe.com. Follow him on Twitter @GlobeRobW.
Correction: Due to incorrect information provided to the Globe, an earlier version of this story incorrectly stated where the pump travels through the body. The pump is extended through the femoral vein into the pulmonary artery.
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