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| Abiomed is launching a trial seeking FDA approval for the Impella RP.--Courtesy of Abiomed |
Now that Abiomed ($ABMD) has steered clear of an FDA warning letter over the Impella 2.5 heart pump, the company has launched a PMA-aimed trial of a percutaneous version of the device, enrolling its first of 30 patients.
The Impella RP is implanted through a patient's leg and steered into the right side of the heart to aid circulation without the need for an invasive procedure, Abiomed says, and the company is planning to test the device in patients with right-side heart failure after surgery or left ventricular assist device implantation.
The study's first implant took place at Philadelphia's Einstein Medical Center, led by Cardiothoracic Surgery Chairman Mark Anderson, who said the device has the chance to treat an unmet need for high-risk patients.
"The Impella RP gave this patient a level of hemodynamic support that allowed our heart failure team to treat the patient's right-sided heart failure quickly in a minimally invasively manner," Anderson said in a statement.
Abiomed hasn't set a timeline for when it expects to get Impella RP approved by the FDA, a spokeswoman said, but the start of the study is good news for a devicemaker crawling back from regulatory woe.
Abiomed's shares tanked 31% in November after the agency took issue with how Abiomed billed Impella to customers, saying the company pitched beyond its intended use and FDA-approved indications. But the FDA accepted Abiomed's corrective actions and issued a close-out letter in February, allowing the company to get back to the business of selling and developing heart pumps. Since then, Abiomed has gradually risen about 30%, closing at $18.30 on Monday.
But the Massachusetts devicemaker isn't totally clear of its previous marketing problems. The company still faces an investor-filed class-action lawsuit claiming it misled the public on the way to the warning letter. Abiomed maintains the suit is without merit and says it will "vigorously defend itself."
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