Abiomed (NSDQ:ABMD) said today that it won pre-market approval from the FDA for the latest version of its Impella heart pump. The Danvers, Mass.-based company said the PMA for the Impella 5.5 with SmartAssist covers treatment for cardiogenic shock for up to 14 days. The new pump is 45% shorter than its predecessor and delivers […]
Abiomed claims win over Abbott’s Thoratec in German patent case
Abiomed (NSDQ:ABMD) today claimed a win in a German patent infringement case brought by Abbott (NYSE:ABT) subsidiary Thoratec. The Danvers, Mass.-based heart pump maker said Germany’s highest court ruled in its favor in a patent challenge dating back to 2015. St. Jude Medical acquired Thoratec in October 2015 and was in turn acquired by Abbott […]
FDA grants Shockwave Medical breakthrough device label
Shockwave Medical (NSDQ:SWAV) has won breakthrough device designation from the FDA for the sonic pressure-wave system it has developed to treat calcified coronary lesions. The Santa Clara, Calif.-based company’s C2 IVL (intravascular lithotripsy) catheter is designed to improve blood flow to the heart by fracturing problematic calcium using sonic pressure waves to enable stent delivery, deployment […]
ESC Congress 2019: Biotronik beats Abbott at target lesion failure
Biotronik said yesterday that its Orsiro stent tops the Xience stents made by Abbott (NYSE:ABT) when it comes to target lesion failure, according to data from a clinical trial. The randomized, controlled BioSTEMI trial was the first direct comparison between the two drug-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI). Biotronik announced […]
Abiomed wins extended Medicare coverage for Impella
Abiomed (NSDQ:ABMD) has won a one-year reprieve from a proposed 27% Medicare reimbursement cut to hospitals for the use of its Impella ventricular support device. In April, the Centers for Medicare & Medicaid Services (CMS) floated the rate cut proposal for inpatient surgeries involving external assist devices inserted into the heart, such as Impella. The […]
Abiomed stock keeps on sliding
Abiomed (NSDQ:ABMD) shares continued to plummet today following a tough earnings report, closing down -26.45% to $204.87 each. The Danvers, Mass.-based medical device maker reported fiscal first-quarter sales that missed the mark and lowered its top-line outlook on the rest of the year. Abiomed posted profits of $88.9 million, or $1.93 per share, on sales […]
Abiomed plunges on fiscal Q1 earnings miss, lowered outlook
Abiomed (NSDQ:ABMD) shares came under pressure today after the medical device maker reported fiscal first-quarter sales that missed the mark and lowered its top-line outlook on the rest of the year. Danvers, Mass.-based Abiomed posted profits of $88.9 million, or $1.93 per share, on sales of $207.7 million for the three months ended June 3o, […]
Report: “Unglamorous” medtech outshines biopharma in 2019
Medtech merger and acquisition deal announcements slowed in the first half of 2019, but the industry got a boost from Verily’s $1 billion round of funding — the largest ever for a medtech firm. The Verily round was twice the size of the biggest-ever VC deal for a biotech company, according to the Vantage Half-Year […]
FDA: Survival rates still low for Impella RP patients outside narrow patient selection criteria
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 […]
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