The Pipeline

CRT 2014: What role will MitraClip play in valve programs?

Jake Kahane, Service Line Strategy Advisor

As one of the most common heart valve problems, mitral regurgitation (MR), which affects four million adults in the U.S., has significant market potential. For this reason, unsurprisingly, the FDA approval of the MitraClip—the first percutaneous device for treating MR—has caught the attention of planners across the country. Progressive valve program leaders see MitraClip as a unique opportunity to differentiate their programs.

As more planners consider adopting this technology, it is important to understand what role the MitraClip will play in valve programs—both in the near-term and long-term. Experts at this year’s Cardiovascular Research Technologies (CRT) conference looked to tackle this question.

MitraClip approved for degenerative MR population at risk for surgery

A major focus area for those considering MitraClip adoption is the market opportunity. Mitral regurgitation is classified into two categories: degenerative (primary) and functional (secondary) MR. While functional MR represents nearly 80% of the patient population, it is much harder to treat with surgery because the left ventricle continues to expand after the procedure, often causing the valve’s flaps to separate again.

As such, the MitraClip is currently indicated for the smaller degenerative MR population, which surgery treats relatively well. Plus, the indications only include patients at prohibitive risk for surgery, further narrowing the patient population.

While MitraClip undoubtedly expands interventional treatment options for these patients, current indications limit the clinical role Mitraclip will play in a valve program in the near-term. Experts estimate a total MitraClip patient population of approximately 20,000 to 30,000 in the U.S.

Beyond market potential, financial hurdles stymie adoption

As MitraClip’s potential patient pool is currently limited, hospital planners must also consider the device’s financial implications. With device costs of approximately $25,000 to $35,000—not including additional operational costs—the financials can be staggering.

Moreover, given expected reimbursement rates range from $10,000 to $45,000, MitraClip adoption is financially difficult to rationalize.

Functional MR may be the future “sweet spot” for MitraClip

While MitraClip’s current financials and patient indications will likely soften adoption in the near term, future indications may broaden the patient population to functional MR. Data from EVEREST II trial suggest that the device may be an effective treatment for functional MR patients.

If approved to treat functional MR, MitraClip would fill a significant gap in current treatments and gain access to a much larger market—making the device a crucial component of any advanced valve program.

With the structural heart disease revolution well underway in interventional cardiology, planners should keep a watchful eye on evolving mitral valve treatments. The ongoing COAPT randomized trial, which is still in its early stages, will further investigate the role of MitraClip in treating patients with functional MR. In addition, experts at CRT announced that new guidelines on the treatment of MR will released later this year.

Learn More

Stay tuned for updates on findings from the COAPT trials, breaking news on treatment guidelines, and what it means for your program’s strategy.

Contact your Dedicated Advisor to help answer your investment questions and develop the best growth strategy for your valve program.