Medtronic reveals positive data from new TAVR study for extreme-risk patients

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

Medtronic ($MDT) revealed new data from a study that shows its transcatheter aortic valve is effective in treating extreme-risk patients with severe aortic stenosis who are too frail for traditional open-heart surgery.

The study evaluated 150 individuals from the company's CoreValve U.S. Pivotal Trial who were not eligible for transcatheter aortic valve replacement (TAVR) through the femoral artery. After being treated with Medtronic's CoreValve device, the rate of death or major stroke for these individuals was 39.4% at 12 months, compared to 26% in patients who were treated through the femoral artery, the company said in a statement. Rates of moderate or severe aortic regurgitation were low, 2.4% at one year following the study, and 85.7% of patients had improved at the one year mark. The company unveiled its findings at the 94th American Association for Thoracic Surgery Annual Meeting.

"The data presented today demonstrate that multiple implant approaches with the CoreValve System provide positive alternatives for very sick patients who have no other options. These data show that more patients can safely and successfully be treated," said Dr. Michael Reardon, professor of cardiothoracic surgery at The Methodist DeBakey Heart & Vascular Center, in a statement.

Positive study results could bode well for Medtronic, as it continues its ongoing patent battle with Edwards Lifesciences ($EW) over the companies' competing transcatheter heart valves. Earlier this month, a U.S. District Court in Wilmington, DE, issued a preliminary injunction against Medtronic's CoreValve system, limiting sales of the device in the U.S. Medtronic fought back with an emergency motion filed in a U.S. Circuit Court of Appeals, claiming that the injunction "would leave no or an inferior treatment option for many patients on the verge of death due to malfunctioning aortic valves," the company said in its filing. Edwards' Sapien product cannot serve individuals with aortic annuli larger than 25 mm.

The Federal Circuit Court of Appeals agreed, and recently delayed the injunction against Medtronic's CoreValve device. The injunction was scheduled to take effect April 23, but now will only occur if the Appeals court rules that it was properly granted, the company said in a statement. The last appeal brief is due June 19.

"We believe this ruling is good news for patients who need the CoreValve device, and our primary objective has been to work closely with physicians to ensure that their patients are able to get the therapy they need," Medtronic Structural Heart President John Liddicoat said in a statement.

Meanwhile, the companies continue to dispute their products' superiority. Medtronic cited a portion of the U.S. District Court ruling that called its device safer, and Edwards touted results from a European study that found Sapien is more likely to be implanted correctly and prevent blood from leaking across the aortic valve.

- read the release
- here's Medtronic's filing (PDF)

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