Abbott’s MitraClip Heart Device Wins Long-Awaited, Narrower Approval

Abbott got a long-awaited green light on its MitraClip device for mitral regurgitation. The device could bring in peak sales of $600 million to $900 million, analysts say.

The approval follows a three-year wait at the FDA. The company’s EVEREST II trial was a trouble spot during the PMA review because it originally focused on patients who were eligible for mitral valve surgery, Leerink Swann analyst Danielle Antalffy notes.

In March, an advisory panel voted 5-3 that the benefits of the MitraClip outweigh the risks. But the panel felt Abbott did not prove MitraClip offered a better benefit-risk profile than surgery. That concern influenced the final, narrow indication for the device: high-risk patients who are ineligible for surgery. Still, the narrower indication is welcome news after FDA review documents, released before the panel meeting, showed reviewers did not feel the device should be approved.

Abbott still faces a challenge in improving reimbursement rates for the first-in-class device, Antalffy says, citing “the unfavorable current reimbursement profile for MitraClip.”

The reimbursement rate for MitraClip’s diagnosis-related group averages $17,000, significantly shy of the $45,000 Abbott is seeking for transcatheter aortic valve replacement, which has a similar price tag to MitraClip, Antalffy says. MitraClip is expected to cost about $30,000.

“Over the next year, [Abbott] will work with CMS and private payors to improve reimbursement, potentially through a national coverage determination, and will hopefully qualify for the new technology add-on payment beginning October 2014, which could add an additional $15k,” she adds.

Abbott is likely to launch the product in stages, beginning with high-level heart centers.

Meanwhile, the company is conducting two prospective, randomized trials of the device’s impact on heart-failure progression. Data from those studies could also support more favorable reimbursement and expanded indications, the company said. 

When the FDA approves your device for a specific indication or set of indications, you aren’t supposed to promote its use for other things. Device Off-Label Promotion Squarely On FDA's Radar Screen is the webinar that will take you through all the tips, tricks and technicalities needed to always stay out of trouble with the FDA. Reserve your spot in this webinar today.