The U.S. Court of Appeals for the Federal Circuit has brought back a patent infringement case between Getinge’s Maquet and Johnson & Johnson’s Abiomed. This lawsuit dates back to 2016, when heart pump maker Abiomed, now a Johnson & Johnson MedTech unit, sued Getinge’s Maquet for a judgment of non-infringement of a trio of patents. Counter-suits later […]
Abiomed
J&J’s Abiomed updates Impella RP instructions in Class I recall
The FDA today issued a notice informing customers of updated instructions for the Johnson & Johnson MedTech Abiomed Impella RP heart pump. Impella RP offers up to 14 days of use in patients who develop acute right heart failure after left ventricular assist device (LVAD) implantation. Placed in the internal jugular vein, it supports the […]
The biggest cardiovascular tech stories from TCT 2024
The 2024 edition of the Transcatheter Cardiovascular Therapeutics (TCT) conference once again highlighted significant innovations in cardiovascular care. This year’s event in Washington, D.C., featured company updates on all types of technologies, including heart valves, access and closure devices, drug-eluting implants, intravascular lithotripsy (IVL), renal denervation (RDN) and more. Some of the biggest names in […]
Johnson & Johnson has positive Impella ECP heart pump data
Johnson & Johnson MedTech reported positive data for the Abiomed Impella ECP transvalvular axial flow pump with compressible pump architecture. Investigators presented results at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C. Dr. Amir Kaki led the FDA IDE study — the first completed pivotal trial for Impella ECP — as principal investigator. J&J said […]
Abiomed reports positive Impella CP results in treating cardiogenic shock
Johnson & Johnson’s Abiomed shared data supporting the use of its Impella CP in patients who had a heart attack with cardiogenic shock. The data was presented at the American College of Cardiology conference and published it in the New England Journal of Medicine. The study evaluated patients who had a heart attack with ST-elevation […]
J&J’s Abiomed has a Class I Impella labeling recall with 49 deaths related to issue
The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind. Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart. This recall (a correction and not a product removal) affects 66,390 Impella pumps […]
FDA issues warning letter to J&J’s Abiomed over Impella heart pump problems
Abiomed, a Johnson & Johnson unit, has received an FDA warning letter related to its Class I recall of Impella heart pumps. The agency wrote Abiomed up for failing to report problems with the heart pump and selling its Impella Connect System software and hardware without FDA authorization. The FDA issued the letter in September after inspecting […]
FDA deems latest Abiomed Impella recall Class I
Abiomed, a Johnson & Johnson unit, issued another recall for some of its Impella heart pumps. This marks the third safety notice regarding the heart pumps in as many months. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge […]
J&J’s Abiomed recalls Impella again — this time it’s TAVR-related
Johnson & Johnson’s Abiomed unit issued another recall for some of its Impella heart pumps. FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from […]
Abiomed recalls some Impella 5.5 with SmartAssist devices
The FDA today issued a field safety notice deeming a recall of Abiomed Impella 5.5 heart pumps as Class I, the most serious kind. Abiomed — bought by Johnson & Johnson for $16.6 billion last year — recalled 466 affected devices. It distributed these Impella 5.5 with SmartAssist devices between Sept. 28, 2021, and March […]
The top 10 cardiac device stories of 2022
From pulsed-field ablation to noninvasive monitoring, this was an exciting year for cardiac device tech. Here are the top 10 cardiac device stories from MassDevice and its sister sites: 10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio Earlier this year, Acutus agreed to sell its left-heart access portfolio to […]
