Medtronic scores FDA approval for TAVR in high-risk patients

Medtronic's CoreValve device
Medtronic's CoreValve--Courtesy of Medtronic

Medtronic ($MDT) won expanded FDA approval for its transcathether heart valve (TAVR) for patients at high-risk for open heart surgery.

The Minnesota device giant had already scored a regulatory OK for its CoreValve system in January, when the FDA chose to forgo an advisory panel review and approve the device for individuals with severe aortic stenosis who were too frail for traditional surgical valve replacement. The latest regulatory blessing allows CoreValve to be used in more high-risk patients at extreme risk for surgery, the company said in a statement.

The agency based its extended approval on a high-risk study in a U.S. Pivotal Trial that compared Medtronic's CoreValve system to traditional surgical aortic valve replacement. At the study's primary one-year endpoint, 85% of patients who received the CoreValve system had survived, as opposed to 80.9% who had received a surgical valve, Medtronic said in a statement. CoreValve patients reported fewer major adverse events at the one year mark, and experienced a low rate of strokes.

"It's rewarding that we can now offer this life-saving therapy to patients at increased risk for surgery," said Dr. John Liddicoat, president of the Medtronic Structural Heart Business. "There is a lot of excitement among U.S. heart teams for the CoreValve System's high risk approval, and its unique design that leads to the clinical outcomes seen in the High Risk Trial. We will continue to safely introduce CoreValve System to these physicians, supporting heart teams through comprehensive training and education, imaging and patient evaluation programs."

The expanded approval bodes well for Medtronic, as the company continues to recoup after its recent patent battle with archrival Edwards Lifesciences ($EW). In May, the companies agreed to a global settlement for their competing transcathether aortic valve replacement devices, allowing both products to remain on the market. The court proceedings took their toll on Medtronic, and the company reported a 54% year-over-year earnings drop in Q4--partly due to a one-time, pretax $746 million litigation charge to cover its now-settled patent dispute.

Regulatory blessings also help Medtronic stay a step ahead of its competition, as Boston Scientific ($BSX) and Edwards forge ahead with their own TAVR products. In April, Boston Scientific touted positive study results that showed that 85% of patients outfitted with its Lotus transcathether aortic valve replacement system had no paravalvular aortic regurgitation. In March, Edwards celebrated a small victory over Medtronic when the first head-to-head comparison of the two firms' competing TAVR valves found that Edwards' Sapien XT had a higher success rate than Medtronic's CoreValve.

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