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Abiomed has received FDA approval for the Impella ECP device, which will be used in the Impella ECP Pivotal Trial. The trial, led by Dr. Amir Kaki, will assess major adverse events in patients undergoing high-risk coronary interventions. Two patients have already been enrolled, demonstrating the device's ability to support complex procedures. Impella ECP is the smallest heart pump, enhancing patient safety and efficiency. The trial aims to enroll up to 217 patients and builds on prior FDA designations for the technology.
Johnson & Johnson (NYSE: JNJ) has extended the expiration of its offer to acquire Abiomed, Inc. (NASDAQ: ABMD) for $380.00 per share, plus a potential $35.00 contingent value right. The new expiration date is set for December 21, 2022. As of December 13, 2022, about 19.3 million shares, or 42.75% of Abiomed's outstanding shares, have been tendered. The acquisition is conditional on the successful tendering of a majority of shares and receiving necessary regulatory approvals. Investors are encouraged to review related filings on the SEC's website for more details.
Abiomed (NASDAQ: ABMD) announces the treatment of the first three patients globally with the newly developed Impella RP Flex heart pump, designed for right heart failure. All patients safely weaned off support, with two returning home. The Impella RP Flex offers patient mobility during treatment and advanced monitoring capabilities via SmartAssist technology. It received FDA approval for acute right heart failure in October 2022 and is being rolled out in key medical centers in the U.S.
ABIOMED, Inc. (NASDAQ: ABMD) reported financial results for the quarter ending September 30, 2022, with revenues reaching $266 million, marking an 11% increase in constant currency. This growth reflects the seventh consecutive quarter of double-digit constant currency growth. U.S. product revenue also increased by 10% to $208 million. However, procedural volumes were affected in July due to physician vacations and labor shortages, which improved by August and September. The company celebrated significant innovation milestones and FDA approvals.
Johnson & Johnson (NYSE: JNJ) has announced the acquisition of Abiomed (NASDAQ: ABMD) for $380.00 per share, valuing the deal at approximately $16.6 billion. The acquisition aims to enhance Johnson & Johnson’s MedTech segment, particularly in the cardiovascular space, addressing significant health needs related to heart failure. The acquisition is expected to be accretive to adjusted earnings starting in 2024. Abiomed's innovative technologies and strong growth potential will complement Johnson & Johnson's existing portfolio, facilitating market expansion in high-growth cardiovascular sectors.
Abiomed (NASDAQ: ABMD) has received FDA pre-market approval for its Impella RP Flex with SmartAssist, designed to treat acute right heart failure for up to 14 days. This innovative device, which is implanted via the internal jugular vein, enhances patient mobility and utilizes dual-sensor technology for optimized management. Key benefits include simplified anticoagulant management and improved patient outcomes when used early in treatment. The product will launch in the U.S. through a controlled rollout in the current quarter.
Abiomed (NASDAQ: ABMD) has announced significant findings from the PROTECT II Randomized Controlled Trial, highlighting that non-Caucasian high-risk PCI patients experience improved outcomes when treated with the Impella heart pump. Compared to those using an intra-aortic balloon pump, results showed a 48% reduction in major adverse events (MAE), 60% in major adverse cardiac and cerebral events (MACCE), and 75% in irreversible events up to 90 days post-procedure. In response, Abiomed is launching the W. Gerald Austen Disparities in Healthcare Initiative to reduce treatment disparities in underprivileged communities.
Patrice Sutherland has been appointed as the new Chairperson of the Board of Directors for MedTechVets, a nonprofit focused on aiding military Veterans in securing jobs in the Medical Technology sector. She succeeds Derek Herrera, effective January 1, 2023. Sutherland, a U.S. Army combat Veteran, brings extensive leadership experience and has been involved in assisting Veterans since joining the board in 2021. Her appointment is expected to enhance MedTechVets' mission, which has already benefited numerous Veterans in transitioning to civilian careers.
Abiomed (NASDAQ: ABMD) announced the FDA has accepted the post-approval study reports for its Impella heart pumps, confirming their safety and effectiveness in various critical conditions. Over seven years, five studies across 46 sites and involving 1,833 patients were completed. The data shows significant improvements in patient outcomes, including survival rates in cardiogenic shock and cost-effectiveness with reductions in hospital stays and costs per case. These findings reinforce Impella's position as a leading treatment in cardiac support.
Abiomed has received 510(k) clearance from the
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