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 […]
Abiomed
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 […]
Johnson & Johnson completes $16.6B Abiomed acquisition
Johnson & Johnson (NYSE:JNJ) announced today that it completed its $16.6 billion acquisition of Abiomed (Nasdaq:ABMD). Abiomed now becomes part of Johnson & Johnson, operating as a standalone business within its MedTech segment. “We are excited to officially welcome the talented Abiomed team to Johnson & Johnson. Their patient-first philosophy aligns with our credo and our […]
Abiomed wins FDA nod for Impella ECP pivotal heart pump trial
Abiomed (Nasdaq:ABMD) announced today that the FDA approved the version of Impella ECP for its upcoming pivotal trial. Danvers, Massachusetts-based Abiomed enrolled the first two patients in its trial following approval. Dr. Amir Kaki, director of mechanical circulatory support at Ascension St. John Hospital in Detroit, led the procedures. The single-arm, prospective, multi-center trial centers […]
Johnson & Johnson extends tender offer for Abiomed acquisition
Johnson & Johnson (NYSE:JNJ) announced today that it extended the expiration date of its offer to acquire Abiomed (Nasdaq:ABMD). Last month, Johnson & Johnson announced its intention to acquire Abiomed for approximately $16.6 billion. Under the agreement, Johnson & Johnson intends to acquire through tender offer all outstanding Abiomed shares. The deal includes an upfront payment […]
FDA tightens indications for Abiomed Impella RP system
The FDA announced today that it is updating the labeling on Abiomed‘s Impella RP system to reflect the final post-approval study results. Abiomed announced in October that FDA had approved the catheter-delivered Impella RP Flex with SmartAssist system. It is Abiomed’s newest system to provide temporary right ventricular support for up to 14 days. People […]