Santa Rosa, CA's Direct Flow Medical added itself to the list of transcatheter mitral valve aspirants at the Annual Zurich Heart Team Mitral Valve meeting in Switzerland. The company aims for a first-in-human implant of the valve before the end of this year.
Interest in the field is inspired by the blow away success of transcatheter aortic valves, at least for early movers Medtronic ($MDT) and Edwards Lifesciences ($EW). The addressable market for minimally invasive mitral valve replacement and repair devices is at least twice as large, but designing such a device poses tougher engineering challenges due to the valve's oblong anatomy and increased complexity.
Like Boston Scientific ($BSX) and St. Jude Medical ($STJ), Direct Flow is a late entrant to the TAVR market, where it is difficult to gain FDA approval in the U.S. and market share internationally. This only adds to the sense of urgency to act fast when it comes to the transcatheter mitral valve arena.
"The valve's unique conformable ring design is ideally suited for the complex shape of the mitral annulus." said Dr. Azeem Latib of San Raffaele Hospital in Milan, Italy, who presented the company's preclinical results during the meeting. "Implanting this valve was similar to implanting the Direct Flow Medical Transcatheter Aortic Valve as I had total procedural control and performed a full hemodynamic assessment prior to deployment."
Meanwhile, Minnesota's Neochord and Israel's Valtech Cardio last week announced German reimbursement for their CE-marked transcatheter mitral valve repair devices. The milestone is especially critical for Valtech because it is trying to rebound from the termination of its planned takeover by Heartware ($HTWR).
While that deal failed due to activist investors, bigwigs Abbott ($ABT), Edwards Lifesciences and Medtronic spent more than a billion dollars acquiring startups in the space over the summer. Left out of the picture is Boston Scientific, which bid for The Foundry portfolio company Twelve, but was outbid by Medtronic, according to an industry source. Boston Scientific later announced that it has a right to acquire Israeli player MValve Technologies to show it's interested in the space.
Edwards made another deal in December when it purchased the right to acquire Baltimore-based Harpoon Medical for an undisclosed sum. Unlike the previous bunch of start-ups, Harpoon is focusing on transcatheter mitral valve repair (rather than replacement), which studies have shown is better for treating the degenerative form of mitral valve disease (as opposed to the functional form).
Abbott boasts the only FDA-approved device for transcatheter mitral valve repair. The company has said that its MitraClip earns about $250 million per year. There are no FDA-approved transcatheter replacement devices for the mitral valve.
Dr. Jeffrey Shuren, the head of FDA's device arm (CDRH), has vowed not to be late to approve them compared to Europe, as was the case when it came to TAVRs, which arrived stateside 5 years after their CE mark approval in Europe, by which time they were already being adopted commercially on a widespread basis across the Atlantic.
- read the release from Direct Flow
- read the release from Neochord and Valtech about German reimbursement