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 […]
Abiomed
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 […]
Abiomed stock skyrockets on Q3 results ahead of Johnson & Johnson acquisition
Abiomed (Nasdaq:ABMD) shares soared before hours on third-quarter results and the news of its acquisition by Johnson & Johnson (NYSE:JNJ). Johnson & Johnson announced this morning that it agreed to buy Abiomed for $16.6 billion. Shares of ABMD skyrocketed up more than 50% at $378.30 apiece in morning trading today. MassDevice‘s MedTech 100 Index, which includes […]
Johnson & Johnson to acquire Abiomed for $16.6B
Johnson & Johnson (NYSE:JNJ) announced today that it agreed to acquire Abiomed (Nasdaq:ABMD) for approximately $16.6 billion. Under the agreement, Johnson & Johnson intends to acquire through tender offer all outstanding Abiomed shares. That amounts to an upfront payment of $380 per share in cash. Johnson & Johson plans to complete the transaction before the […]
FDA approves Abiomed Impella RP Flex with SmartAssist for treating right heart failure
Abiomed (Nasdaq:ABMD) announced today that the FDA granted its Impella RP Flex with SmartAssist pre-market approval (PMA). Danvers, Massachusetts-based Abiomed designed the Impella RP Flex with SmartAssist to treat right heart failure. It does so for up to 14 days. The company intends to introduce Impella RP Flex in the U.S. through a controlled launch […]
5 top trends shaping the medtech industry
Ashley McEvoy is an industry veteran and the EVP and worldwide chair of Johnson & Johnson MedTech. Michael Minogue, another veteran, serves as chair, president and CEO of heart pump maker Abiomed. Together, the two bring a wealth of medtech industry knowledge to the table. They demonstrated that in a “CEOs Unplugged” discussion at AdvaMed’s […]
Abiomed reaches new regulatory milestone for its Impella pumps
Abiomed (Nasdaq:ABMD) announced that the FDA accepted and closed its post-approval study reports for its Impella heart pumps. Danvers, Massachusetts-based Abiomed’s study reports relate to Impella’s premarket approvals (PMA). The company said in a news release that the FDA’s action represents “another affirmation” of the safety and effectiveness of Impella heart pumps. Impella pumps treat […]
FDA clears Impella low-profile sheath from Abiomed
Abiomed (Nasdaq:ABMD) announced today that it received FDA 510(k) clearance for its Impella low-profile sheath. Danvers, Massachusetts-based Abiomed designed its sheath to maintain the same inner diameter as the existing 14 French (Fr) sheath used for Impella CP placement. However, the new sheath reduces the outer diameter by nearly 2 Fr. The sheath’s smaller size, […]
