W. L. Gore & Associates (Gore) has acquired Conformal Medical in bid to strengthen the US multinational’s endovascular portfolio.
Gore will inherit Conformal’s lead product candidate, the CLAAS AcuFORM system for left atrial appendage (LAA) closure. The device, which is currently in clinical trials, is claimed to be the first device to use conformable foam to seal the LAA.
A one-time procedure for patients with non-valvular atrial fibrillation (AFib), CLAAS is an implantable intended to reduce the risk of blood clots associated with stroke from forming in patients’ LAA and eliminate the need for this patient population to require long-term anticoagulant therapy.
The transaction, the terms of which have not been publicly disclosed, is expected to close in early 2026.
In support of CLAAS’s pre-commercialisation activities, Conformal recently closed a $32m Series D funding round, bringing the New Hampshire-based company’s total funding to date to $161m.
“The investigational CLAAS AcuFORM System represents the kind of transformative, science-driven innovation that reflects our long-term commitment to improving patient care,” said Gore CEO Bret Snyder.
“It is an ideal fit with our endovascular portfolio and a strong complement to our existing cardiac products,” Snyder added.
CLAAS’s safety and efficacy is currently under evaluation in the CONFORM pivotal trial (NCT05147792). The trial also aims to establish that the device’s performance is non-inferior to Boston Scientific’s WATCHMAN and Abbott’s Amulet LAA closure devices.
Patients eligible for the trial, which recently enrolled its first EU-based patient, will be randomised to receive either CLAAS, WATCHMAN, or Amulet and be followed for five years after device implant, according to an entry on Clinicaltrials.gov.
A GlobalData market model reveals that Boston dominated the US LAA market in 2025 with an 80% share, followed by Abbott with an 11.7% market share. The first iteration of Boston’s WATCHMAN entered the US market in 2015, while Abbott’s Amulet released in 2021.
According to GlobalData analysis, the LAA closure devices market is growing at a CAGR of 9.1% and projected to hit a valuation of around $5.5bn in 2034, up from $2.3bn in 2024.
