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Home » Abiomed Inc.

Articles Tagged with ''Abiomed Inc.''

Edwards seeks to add three months to Ultra Resilia patent

July 9, 2025
By Mark McCarty
The U.S. FDA noted in a series of Federal Register declarations that several device makers are working with the Patent and Trademark Office to claim regulatory review times for their devices, including the Sapien 3 Ultra Resilia device by Edwards Lifesciences Corp.
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J-J-Medtech-logo

J&J rebrands med-tech subsidiaries

Sep. 10, 2024
By Annette Boyle
Johnson & Johnson subsumed five of its medical technology business under the Johnson & Johnson Medtech name. Ethicon, Depuy Synthes, Biosense Webster, Abiomed and Cerenovus no longer exist as independent entities, but J&J announced no changes in the product lineup.
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V-Wave

J&J pumps up cardiac commitment with $1.7B V-Wave acquisition

Aug. 20, 2024
By Annette Boyle
Johnson & Johnson (J&J) aims to add a fourth cardiac business to its portfolio in less than two years with the acquisition of V-Wave Ltd., which makes the Ventura interatrial shunt system for the treatment of heart failure. J&J will pay $600 million up front and an additional $1.1 billion contingent on meeting specified regulatory and commercial milestones. The deal is slated to close before the end of the year.
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Elevate system

Magenta hauls in $105M for miniaturized heart pump

July 23, 2024
By Shani Alexander
Magenta Medical Ltd. raised $105 million in financing that will go toward clinical trials and to secure U.S FDA approval for its Elevate system, the world's smallest heart pump. The substantial investment haul was “a vote of confidence” from the investor community for what the company is doing, David Israeli, CEO of Magenta told BioWorld.
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Impella CP

Abiomed’s Impella CP reduces mortality 12.7% in cardiogenic shock

April 9, 2024
By Annette Boyle
Routine use of Impella CP in patients who had a heart attack with cardiogenic shock cut mortality by 12.7% at six months compared to standard care, researchers reported in a late breaking presentation at the American College of Cardiology Scientific Sessions in Atlanta.
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Heart scientific overlay

J&J paces interventional cardio market with $13B Shockwave buy

April 5, 2024
By Holland Johnson
Med-tech powerhouse Johnson & Johnson made a bold bid to bolster its interventional cardiology holdings with the news on April 5 that it is acquiring Shockwave Medical Inc. for approximately $13.1 billion including cash acquired. The $335 per share cash price represents a more than 5% premium to Shockwave’s (Nasdaq: SWAV) April 4 closing price.
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Abiomed Impella

Abiomed recalls Impella devices citing risk of ventricle perforation

March 22, 2024
By Mark McCarty
The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement. The FDA noted that it has received 129 reports of serious injury and 49 reports of fatalities associated with these devices, but did not indicate whether device malfunction was the source of these adverse events. Abiomed advises customers that the device should be implanted “with special care” in patients during active cardiopulmonary resuscitation, and to review some updated warnings in the product’s instruction for use statement.
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iVAC2L device

Pulsecath receives CE mark under MDR for heart failure support device

March 14, 2024
By Shani Alexander
Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took us four years and we spent more than €700,000 to get approval under the MDR for the same product that we already had CE mark for under the Medical Device Directive for the last 10 years or so,” Oren Malchin, CEO of Pulsecath, told BioWorld.
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Regulatory icons
2023 FDLI Enforcement Conference

Abiomed warning letter for final deviation seen as opening salvo

Dec. 7, 2023
By Mark McCarty
The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.
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U.S. FDA headquarters

Abiomed stung by FDA’s final guidance for clinical decision support in warning letter

Oct. 11, 2023
By Mark McCarty
The U.S. FDA’s final guidance for clinical decision support (CDS) systems may be the subject of two citizen’s petitions requesting the agency scrap the guidance and start over, but that doesn’t mean the agency is not enforcing the terms of the guidance. Danvers, Mass.-based Abiomed Inc., took in a Sept. 19 warning letter stating that the company’s Impella Connect system qualifies as a CDS product because it provides “patient-specific medical information to detect a life-threatening condition,” an interpretation that is sure to intensify the larger debate about whether the CDS final guidance is an extra-statutory exercise in regulatory engineering.
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