A New Hampshire device company reimagining stroke prevention for atrial fibrillation - with a conformable foam implant that molds to the heart instead of forcing the heart to fit the device.
Deep inside the left side of the heart sits a small, irregular sac called the left atrial appendage. In patients with atrial fibrillation - an irregular heartbeat that affects millions - blood can pool and clot there. When a clot escapes, it can travel to the brain and cause a stroke. For decades, the standard defense was lifelong blood thinners. But many patients cannot tolerate them.
Conformal Medical, founded in Nashua, New Hampshire in 2016, built its company around a different defense: physically sealing the appendage shut. That approach, called left atrial appendage occlusion, or LAAO, already exists on the market. Conformal's wager was that the existing devices were harder to place, harder to size, and harder to scale than they needed to be.
Its answer is the CLAAS AcuFORM System. At its core is a proprietary conformable foam matrix - a material that molds itself to the varied, unpredictable shapes of each patient's appendage. Where competing implants come in as many as six rigid sizes, Conformal's design covers a broad anatomic range with just two.
That single design choice ripples outward. Simpler sizing means a simpler procedure. Conformal's stated goal is to turn LAAO into a same-day, single-operator intervention that can be guided by intracardiac echocardiography under local anesthesia - potentially avoiding the general anesthesia and transesophageal echocardiography that many procedures rely on today.
The clearest way to understand Conformal's pitch is to compare the procedure it wants to replace with the one it proposes. The difference is less about the implant alone and more about everything the implant lets you remove.
Approach as described by the company and its trial program. AcuFORM is investigational; claims are being evaluated in the CONFORM pivotal trial.
The LAAO market is estimated at roughly $1.5 billion today, with projections toward $4-5 billion by 2030. Boston Scientific's WATCHMAN holds an estimated 90% share. Conformal's thesis: the market is capped less by patient demand than by procedural friction. Make the procedure easier, and the number of eligible, treatable patients grows.
Figures are industry estimates cited by the company's CEO; procedure counts describe annual LAAO volume and its potential growth. Not a financial forecast.
The next-generation foam-based LAAO implant. Conforms to a broad range of anatomies with two sizes; designed for a same-day, single-operator, ICE-guided procedure. Investigational in the U.S.
The original conformable foam LAA closure platform that established the anatomic-seal approach, with early clinical results presented at TCT 2020.
Interventional cardiologists, electrophysiologists, and hospital structural-heart programs treating AFib patients at stroke risk - especially those who cannot tolerate long-term anticoagulation.
Develops, clinically validates, and - upon approval - intends to sell implantable devices to hospitals. Revenue depends on regulatory clearance, reimbursement, and cath-lab adoption.
Conformal Medical was founded in 2016 by Aaron Kaplan, Carol Devellian, and Andy Levine, who set out to solve the fit problem at the heart of LAA closure with a foam-based implant.
The company is led by President and CEO James Reinstein, who brings more than 30 years in medical devices. He spent 17 years at Boston Scientific, including commercial leadership across Asia, helped grow Cyberonics' market value from roughly $200 million to $3 billion, and led Aptus Endosystems to a $120 million acquisition by Medtronic.
Reinstein's guiding maxim - "think commercially from day one" - shows in how Conformal pairs its science with reimbursement and workflow planning. When the pivotal trial hit a safety pause, he personally addressed all 50 trial sites; none withdrew.
The clinical program is guided by scientific advisors including Shephal Doshi, MD (Pacific Heart Institute), William Gray, MD (Lankenau Heart Institute), Devi Nair, MD (St. Bernards Medical Center), and Christopher Ellis, MD (Vanderbilt Health).
Aaron Kaplan, Carol Devellian, and Andy Levine start Conformal Medical to build a conformable foam LAA closure device.
Early feasibility results for the foam-based CLAAS system presented at TCT 2020, backed by a large Series C round.
Oversubscribed Series D led by SPRIG closes; NEVCA names Conformal its 2023 Powerhouse MedTech Company of the Year.
The next-generation CLAAS AcuFORM LAAO System takes the spotlight at a leading interventional cardiology conference.
CONFORM pivotal trial passes 500 patients; a $32M Series D extension closes and the first E.U. patient is enrolled.
Gore completes its acquisition on February 19, 2026; Conformal becomes a wholly owned subsidiary continuing its clinical program.
The implant's core is literally conformable foam - it molds to the heart rather than the reverse.
Two device sizes span a wide anatomic range where competitors offer up to six.
Its tagline plays on geometry: "the shape of stroke prevention."
Reinstein helped grow Cyberonics from $200M to $3B and led Aptus to a $120M Medtronic exit.
Gore is behind more than 50 million implanted medical devices worldwide.
A ~56-person New Hampshire company entering a $1.5B, incumbent-dominated market.
The CLAAS AcuFORM System, an investigational left atrial appendage occlusion (LAAO) implant that uses a conformable foam seal to reduce stroke risk in patients with non-valvular atrial fibrillation.
Its foam-based design conforms to a wide range of anatomies using only two sizes (versus up to six for competitors) and is meant to enable a same-day, single-operator procedure without general anesthesia or transesophageal echocardiography.
No. As of early 2026 the CLAAS AcuFORM System is investigational and being studied in the CONFORM pivotal trial toward U.S. pre-market approval; it is not yet commercially available.
W. L. Gore & Associates completed its acquisition on February 19, 2026. Conformal now operates as a wholly owned Gore subsidiary and continues its clinical studies.
James Reinstein is President and CEO. The company is headquartered in Nashua, New Hampshire, and was founded in 2016.