The pivotal ADVENT trial of the Farapulse pulsed field ablation system developed by Boston Scientific Corp. returned positive results at one year, according to a presentation at the ESC Congress 2023 that was simultaneously published in the New England Journal of Medicine. The study compared Farapulse, a nonthermal treatment that ablates heart tissue, to radiofrequency or cryoablation for paroxysmal atrial fibrillation.

Researchers develop AI robotic device that can self-adapt to deliver personalized drug treatment

Researchers have created an artificial intelligence-enabled implantable bio-sensing device that can change shape and adapt to maintain drug treatment and bypass scar tissue build up. As the foreign body response continues to impact the longevity of implantable medical devices that treat many conditions, the researchers hope that the Fibrosensing Dynamic Soft Reservoir, capable of monitoring fibrotic capsule formation and overcoming its effects via soft robotic actuations, can change the way a patient’s body responds to therapeutic treatments.

Magenta Medical completes early feasibility study on miniature heart device

Four months after raising $55 million, Magenta Medical Ltd. reported the completion of enrollment to a U.S. FDA-approved early feasibility study with the Elevate percutaneous left ventricular assist device. All 15 patients in the study were enrolled and successfully treated at Mount Sinai Hospital, St. Francis Hospital and Heart Center, and North Shore University Hospital. This study was approved by the FDA to evaluate the safety and feasibility of the world’s smallest heart pump as a temporary mechanical circulatory support device during high-risk percutaneous coronary intervention procedures. “It constitutes the first step in our clinical program intended to secure approval for the device in the U.S. for this indication,” David Israeli, CEO of Magenta Medical, told BioWorld.

Magassist bags FDA breakthrough nod for ventricular assist device

Magassist Co. Ltd. has been granted breakthrough designation by the U.S. FDA for its interventional ventricular assist device, which is expected to accelerate the development and approval of the product. Nyokassist features a 9Fr insertion size and a foldable catheter pump to make insertion and removal from the body easier. The 9Fr insertion size “is believed to be the smallest in the current market,” Magassist told BioWorld.

Med-tech associations take aim at onerous EU med-tech regulations

The German med-tech associations Bvmed and VDGH have hit out at the shortcomings of the EU medical device regulations and are calling for action to improve implementation, predictability and transparency of the system. Among other measures they want to see the abolition of the requirement to renew CE certificates every five years in favor of a cycle based on post-market surveillance data; for the requirement for class B in vitro diagnostics to be approved by a notified body to be dropped; and the introduction of fast-track procedures for breakthrough products and orphan devices.

Holiday notice

BioWorld's offices will be closed in observance of Labor Day in the U.S. No issue will be published Monday, Sept. 4.

Also in the news:

Rapid Medical, Mölnlycke, Statlab, StatLab, Tarsadia Investments, Vista.ai, Hekabio.