The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA. That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 patients among […]
Appeals court tosses former Abiomed Asia exec’s lawsuit
This article has been updated with a comment from Abiomed. A federal appeals court has dismissed the wrongful termination law suit of a former Asia VP for Abiomed (NSDQ:ABMD). The three-judge panel ruled on Nov. 27 that Keisuke Suzuki failed to prove that Abiomed owed him compensation in the form of company stock options for […]
Abiomed stock recovers some as company further questions critical Impella studies
Shares of heart pump company Abiomed (NSDQ:ABMD) recovered a bit today — a day after the company’s stock took a 20% dive after two critical studies came out of American Heart Association’s Scientific Sessions. The two separate studies — one led by researchers in St. Louis, the other out of San Francisco — suggested potentially serious complications […]
BREAKING: Abiomed stock down 20% after new research raises questions about Impella
Shares of heart pump company Abiomed (NSDQ:ABMD) fell today after research released over the weekend suggested potentially serious complications involving the company’s Impella heart pumps. Abiomed stock was down more than 20%, to $178.09 per share, by the close of trading after news of the two studies came out of the American Heart Association’s Scientific Sessions […]
Abiomed jumps on fiscal Q2 earnings beat
Abiomed (NSDQ:ABMD) shares got a pre-market jump today from fiscal second-quarter earnings that topped the consensus forecast once some $35 million in unrealized losses from its stake in Shockwave Medical (NSDQ:SWAV) were factored in. The Danvers, Mass.-based heart pump maker posted profits of $13.1 million, or 28¢ per share, on sales of $205.0 million for […]
Abiomed touts real-world data on right-side heart failure with Impella RP
Abiomed (NSDQ:ABMD) said today that real-world data on its Impella RP heart pump showed a survival rate that matched that of its pre-approval study when following the FDA’s approved protocol for the device. The Impella RP is designed to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or […]
Abiomed wins FDA approval for latest Impella heart pump
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 […]
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