London-based medical device company LivaNova PLC is acquiring Maple Grove's Caisson Interventional LLC in a bid to join the global movement to produce a safe and effective minimally invasive mitral valve for the heart.
Caisson Interventional sold to London firm as heart-valve race revs up
After investing in the Maple Grove heart valve company in 2012, LivaNova is buying the company.
May 4, 2017 at 1:57AM
LivaNova said Tuesday that it would pay $72 million to acquire the remaining 51 percent of Caisson that it didn't already own. That price includes $6 million in debt forgiveness. LivaNova initially invested in privately held Caisson in 2012.
The deal comes eight months after Caisson announced its first successful human implants of its Caisson TMVR System in a 20-patient study at five U.S. hospitals. The study was authorized under the Food and Drug Administration's early feasibility study program, which is designed to encourage more cutting-edge medical device research in the U.S.
The Caisson TMVR System is intended to replace a severely diseased or damaged heart valve that doesn't close tightly enough, allowing blood to flow backward in the heart — a condition called mitral regurgitation.
Traditional surgery requires a doctor to open a patient's chest to access the valve, but "transcatheter" valves can be delivered through narrow tubes inserted in a small leg incision and advanced to the heart. The heart has four valves, but so far only the aortic valve has a government-approved transcatheter option; the mitral valve is widely seen as the next.
LivaNova said it intends to make Caisson's novel transcatheter replacement system the "cornerstone" of its efforts to enter the market for minimally invasive mitral valves, joining a burgeoning effort to produce such a device.
In 2015, Abbott Laboratories paid $225 million to acquire Roseville's Tendyne Holdings, which is testing a mitral valve replacement system. That same year, Medtronic agreed to pay more than $400 million to acquire a California mitral-valve start-up called Twelve, and Boston Scientific invested $200 million in Israeli mitral valve firm MValve Technologies.
Transcatheter mitral valves are available in the U.S. only through clinical studies.
LivaNova says unlike other systems, the Caisson system is designed solely to be implanted by puncturing a small hole in the tissue separating the heart's upper chambers and only using a single access site to introduce the device into the body. The device position can be adjusted inside the beating heart before final release, allowing doctors to check the fit before deploying it permanently.
"We created this percutaneous mitral valve replacement implant, procedure and delivery system to offer a significant new therapy to patients with severe mitral regurgitation," Caisson co-founder and Chief Operating Officer Todd Mortier said in a news release.
LivaNova CEO Damien McDonald said in the release that the company intends to invest the clinical studies, regulatory approvals and product enhancements needed to launch the Caisson valve commercially. Clinical testing sites in Europe and Canada will soon be added.
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Pioneering surgeon has run afoul of Fairview Health Services, though, which suspended his hospital privileges amid an investigation of his patient care.
