The FDA today updated data from a post-approval study of Abiomed‘s (NSDQ:ABMD) Impella RP heart pump system, reporting a new 30-day survival rate of 28.6% for patients post-explant, hospital discharge or the start of longer term therapy. A total of 12 of the 42 patients enrolled in the post-market trial of the Danvers, Mass.-based medtech […]
Abiomed launches Impella CP SmartAssist platform
Abiomed (NSDQ:ABMD) said today it is launching its Impella CP with SmartAssist, which won FDA approval last March. The launch will begin alongside the 2019 Society for Cardiovascular Angiography & Interventions Scientific Sessions which begins on Sunday, the Danvers, Mass.-based company said. The Impella CP with SmartAssist features improvements intended to simplify patient management, integrate clinical data […]
Abiomed wins expanded, 14-day indication for Impella pumps
Abiomed (NSDQ:ABMD) said today that it won an expanded indication from the FDA for two of its Impella heart pumps, extending their indwell times from six to 14 days. The federal safety watchdog’s decision affects the Impella 5.0 and Impella LD devices used to treat cardiogenic shock, Danvers, Mass.-based Abiomed said. The company won the […]
Ex-Abiomed exec looks to keep wrongful termination suit alive
A former Asia VP for Abiomed (NSDQ:ABMD) is hoping to keep a wrongful termination lawsuit alive in a U.S. federal appeals court. In January Keisuke Suzuki lost a lawsuit seeking $2.1 million in damages for unfair termination and denial of an options deal tied to Japanese approval of Abiomed’s Impella heart pump. The Danvers, Mass.-based company […]
Abiomed wins FDA nod for STEMI Impella trial, sees shares drop on Q4 sales miss
Abiomed (NSDQ:ABMD) said today that the FDA approved the launch of a trial exploring its Impella CP Heart pump’s ability to treat patients undergoing treatment for a STEMI heart attack, and saw shares drop after releasing fourth quarter and full year fiscal 2019 earnings that missed sales expectations on Wall Street. The Danvers, Mass.-based company said […]
Abiomed’s stake in Shockwave is worth at least $58m
The $10 million Abiomed (NSDQ:ABMD) put into Shockwave Medical (NSDQ:SWAV) has paid off so far no matter how you slice it. Shockwave raised nearly $97 million in an initial public offering earlier this month, inking a private-placement deal with Abiomed on the side for $10.0 million worth of SWAV shares at the $17-per-share IPO price. […]
ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group
Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients. Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Danvers, Mass.-based company said. The review follows a release […]
Abiomed adds $10m to $97m Shockwave IPO
Shockwave Medical this week raised nearly $97 million from its initial public offering and inked a private-placement deal with Abiomed (NSDQ:ABMD) for another $10 million. Santa Clara, Calif.-based Shockwave, which is developing a device to treat calcified coronary lesions with sonic pressure waves, said March 6 that it floated 5.7 million shares at $17 apiece, […]
FDA: Interim data from post-market Abiomed Impella RP study shows 17% survival rate
The FDA yesterday said that interim data from a post-approval study of Abiomed‘s (NSDQ:ABMD) Impella RP heart pump system showed only a 17.4% survival rate, approximately 55% lower than the rate noted in the premarket study of the device. The federal watchdog said that it is currently evaluating data from the study and that it will […]
Abiomed touts CE Mark for Impella Connect, posts Street-beating FY2019 Q3 earnings
Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella Connect cloud-based Impella heart pump console and released fiscal year 2019 third quarter earnings that topped expectations on Wall Street. The Danvers, Mass.-based company said its Impella Connect is a cloud-based platform that allows physicians and hospital staff to […]
Abiomed wants whistleblower to cough up employment records
Abiomed (NSDQ:ABMD) yesterday asked a federal judge to force whistleblower Max Bennett to cough up his employment records with another company, countering his retaliatory termination claim by alleging that it fired him for lying about the circumstances of his departure from his last job. Documents unsealed in March 2018 revealed that Max Bennett accused the Danvers, Mass.-based […]
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