Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.
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.
The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
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.
The Cardiovascular Research Technologies 2024 conference in Washington this week demonstrated continued positive outcomes for patients who underwent transcatheter aortic valve replacement with devices made by Abbott Laboratories, Edwards Lifesciences Corp. or Medtronic plc.
The U.S. FDA announced March 7 that Cardinal Health of Dublin, Ohio, has expanded a product correction for Monoject devices to a product removal because of manufacturing changes that could affect product performance.
Haemonetics Corp. appears ready to make a bit of a retro investment, as it entered into a definitive agreement to acquire Advanced Cooling Therapy Inc. (dba Attune Medical) for $160 million at closing plus undisclosed additional contingent payments. Attune manufactures the U.S. FDA-cleared Ensoetm device, which cools the esophagus during radiofrequency cardiac ablation procedures, a treatment for atrial fibrillation whose days appeared numbered.
While preparing a follow-on phase III study of its Cardiamp cell therapy, Biocardia Inc. has mined positive interim data at a mean 20-month follow-up of all patients in the original Cardiamp HF Trial.
On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.
Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.