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.

Cagent Vascular Inc. secured more than $30 million in a series C fundraising round to increase availability of its Serranator PTA serration balloon catheters, which scores the endoluminal surface of arteries to enable greater expansion of obstructed vessels. A recent study demonstrated that Serranator also dramatically reduced elastic recoil, which could improve results of angioplasty in individuals with peripheral artery disease (PAD).

Reprieve Cardiovascular Inc. landed $42 million in its first fundraising round out of stealth to fund development of its acute decompensated heart failure treatment. The series A round will support clinical and development programs, including the ongoing FASTR trial and Reprieve’s upcoming pivotal trial.

Through its intellectual property holding company, Eindhoven, the Netherlands-based Bambi Medical BV is seeking patent protection for an enhancement to its flexible sensor belt that is worn around the abdomen for monitoring the vital signs of neonates.