Abbott's MitraClip gains US approval

Abbott announced Friday that its catheter-based MitraClip therapy gained FDA approval for patients with significant symptomatic degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery. John Capek, head of the company's medical devices unit, remarked "it certainly is exciting to have the opportunity to have this first-of-class kind of therapy where there's a demonstrable need for alternatives." He added that "it's an area where there are a lot of patients (for whom) surgery is not an alternative, and this is an opportunity to improve outcomes."

The device, which Abbott said it will launch immediately, is delivered to the heart through the femoral vein to repair the mitral valve. Once implanted, MitraClip "allows the heart to pump blood more efficiently," which relieves symptoms and improves patient quality of life, the company said. Abbott noted that the device is delivered without the need for an invasive surgical procedure and typically results in short recovery times and short hospital stays of two to three days.

In March, members of an FDA panel voted 5-3 that the benefits of the MitraClip device outweigh its risks. The panel also said the product was safe but voted 5-4 against a question that asked if there was "reasonable assurance" the product was effective.

MitraClip, which Abbott gained through the purchase of Evalve in 2009, has been sold in Europe for five years and is available in Canada through a special access programme. The company is also seeking approval of the device in Asian countries including China and Japan. In addition, Abbott is conducting the COAPT trial in the US and the RESHAPE-HF study in Europe to evaluate the impact of MitraClip treatment on heart failure progression. The company noted that the trials will generate "important clinical and economic data that may support development of treatment guidelines, expanded indications and reimbursement."

According to Capek, international sales of MitraClip grew 50 percent year-over-year in the third quarter to about $30 million. Wells Fargo analyst Larry Biegelsen estimates that the device will generate US sales of less than $200 million a year. Capek said "we estimate on the high side that there are 300 000 to 350 000 patients in the prohibitive risk for surgery category" in the US, adding "our target is probably one-tenth of that, or 20 000 to 30 000 patients." He suggested that "it will take awhile for the product to penetrate the market, but it’s not a small number."

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