If I had a nickel for each time in the past 48 hours a major medtech announced moves in heart implants aimed at reducing a person’s risk of stroke, I’d have two nickels.
Johnson & Johnson MedTech disclosed that it has spent $400 million upfront to purchase Laminar, the maker of a new type of device currently under development for closing off the heart’s left atrial appendage—a small, unnecessary pocket in the heart wall that, among people with an irregular heartbeat, can provide a place for potentially dangerous blood clots to form over time.
The company is the second this week to make news in the space, after Medtronic said Tuesday that the surgical, clip-based Penditure implant—acquired this past summer from Syntheon for an undisclosed amount—would make its market debut.
While Medtronic’s device is designed to be used as a quick add-on procedure in patients with atrial fibrillation who are already undergoing heart surgery for a separate condition, Laminar’s approach more closely aligns with the two main players in the U.S., Abbott and Boston Scientific.
Their Amplatzer Amulet and Watchman FLX devices, respectively, can be implanted through a transcatheter procedure, like Laminar’s. However, where Abbott and Boston Scientific describe their systems as occluders—which unfold to fill the appendage and seal it off from the rest of the heart—Laminar has dubbed its operation a left atrial appendage elimination.
Once the thin nitinol device unfolds into a small ball and is inserted in the pouch, it is twisted around in a circle to gather up the tissue and hold it shut. It is then secured with a patch that leaves comparatively little metal exposed to the heart chamber’s blood flow, with the goal of reducing the chances of clots forming around the device.
“Laminar’s innovative approach will provide Biosense Webster the opportunity to expand our portfolio in this high-growth market, complement our electrophysiology and Intracardiac Echo strengths, and deepen our presence with interventional cardiologists and electrophysiologists,” said Jasmina Brooks, president of J&J’s Biosense Webster division, which will serve as the new home of Laminar’s portfolio.
The acquisition deal also includes additional clinical and regulatory milestone payments of undisclosed amounts, slated for 2024 and beyond, according to the company. J&J said the cost of the deal and future R&D plans would cut into its profit projections for the 2023 fiscal year, lowering adjusted earnings per share by 17 cents, down to an operational range of $9.85 to $9.91, as well as a 15-cent impact to the next fiscal year.
A pivotal human study of Laminar’s device has received a go-ahead from the FDA, and the companies said they plan to begin enrolling participants in early 2024. Laminar previously launched its own early feasibility study in late 2022.
J&J estimates there are about 38 million patients internationally with afib, which can increase their risk of stroke by at least five times. Previous studies have shown that sealing off the left atrial appendage through any means—including surgical sutures or other devices—could cut that risk by more than one-third.
Biosense Webster previously acquired a left atrial appendage occluder through a 2015 deal for Coherex and its CE-marked WaveCrest system, available in Europe since 2013. J&J would later announce it had enrolled its first participant in a U.S. clinical trial of the implant in early 2018, with the device aimed at patients who could not tolerate long-term regimens of blood thinner medications.