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FDA Approves Medtronic's CoreValve; Device Available Immediately in U.S.
Approval Earlier Than Expected; FDA Waives Standard Panel Discussion Due to Extremely Positive Trial Results
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Medtronic's CoreValve
Medtronic's CoreValve
January 17, 2014 (updated with a statement from Edwards) -- This morning the U.S. Food and Drug Administration approved Medtronic's self-expanding transcatheter CoreValve® system for patients who are too sick to withstand traditional aortic valve replacement open heart surgery.

Although an approval had been expected during the first half of this year, today's announcement took the cardiology community by surprise. The CoreValve sytem is now the second transcatheter aortic valve device available in the U.S., breaking the monopoly currently enjoyed by the Edwards Sapien valve for high risk patients. A Medtronic spokesperson confirmed to Angioplasty.Org that the CoreValve is available as of today for use in the United States.

CoreValve was initially approved for use in Europe seven years ago and has since been implanted in over 50,000 patients.

FDA Waived Need for Panel Due to Highly Positive Results
Normally FDA approval of a device isn't granted until a panel of experts is convened to review all of the clinical data, hear testimony and then vote on a recommendation. The full FDA then makes a final decision based on the panel's report. This process can delay availability of a new device up to a year or more from the presentation of study results until approval and availability of the device to the medical profession.

However, as reported previously by Angioplasty.Org, the results presented on October 29, 2013 were so positive for the high-risk patients that the FDA took the unusual step of announcing that it would bypass the preliminary panel step. However, the less than three month turnaround from trial presentation to FDA approval was extremely rapid.

Approval Encompasses Entire CoreValve Platform
Additionally the FDA approval is for the entire CoreValve platform, including the CoreValve Evolut™ 23mm, as well as the CoreValve 26mm, 29mm and 31mm valves. Because of this broad range of sizes, the CoreValve System has an advantage over the only other transcatheter valve available in the U.S., the Edwards Sapien valve, which is available only in 23mm and 26mm.

CoreValve also requires a significantly smaller insertion site than the Sapien (18F, compared to 22F), important in elderly patients whose femoral arterial system may not permit passage of the larger devices.

Edwards vs. Medtronic: "Valve Wars"
As reported by Angioplasty.Org earlier this week, Edwards prevailed in a patent lawsuit against Medtronic for "willfully infringing" the Cribier patent held by Edwards. Damages of almost $400 million were awarded to Edwards, and Edwards indicated that it would seek a permanent injunction against Medtronic's sale of the CoreValve. Medtronic immediately appealed the verdict, stating that they "believe the Federal Circuit Court of Appeals will find no merit to Edward's infringement claim. Today's jury verdict does not impose an injunction, and Medtronic will oppose any requests for an injunction by Edwards."

A patent suit and injunction were initially obtained in a similar patient case in Germany, which were subsequently overturned on appeal by Medtronic.

Regarding both the legal issues and the availability of the CoreValve in the U.S., a Medtronic spokesperson stated to Angioplasty.Org today that, "Medtronic is appealing the Cribier jury verdict, which is likely to take 14-18 months on the infringement appeal. There is no is available today."

As for Edwards Lifesciences, a spokesperson reaffirmed to Angioplasty.Org today the statement in Wednesday's press release, that Edwards "will move to enforce this verdict and intends to seek a permanent injunction." Edwards' stock price closed today down 5.68%.

This morning's press release from Medtronic, Inc. follows:

Medtronic CoreValve® System Obtains Early FDA Approval on Exceptional Clinical Performance
Self-Expanding Aortic Valve Serves Broad Spectrum of Potential Transcatheter Aortic Valve Replacement (TAVR) Patients Who Are Unable to Undergo Surgery

January 17, 2014 -- Minneapolis -- Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve® System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Untreated, these patients have a risk of dying approaching 50 percent at one year.

The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, which demonstrated that the CoreValve System is safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported.

The Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5 percent, which was 40.7 percent lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA). At one month, the rate of stroke was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. Additionally, 75.6 percent of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the U.S. pivotal Trial, demonstrated even better survival and stroke performance.[1]

Dr. Jeffrey J. Popma
Dr. Jeffrey J. Popma

"The low rates of stroke and valve leakage with the CoreValve System - two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life - set a new standard for transcatheter valves," said Jeffrey J. Popma, M.D., director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, and co-principal investigator of the Trial. "The CoreValve U.S. Pivotal Trial was rigorously designed and applied clinical best practices. The trial results have redefined optimal TAVR outcomes in the areas that matter most to physicians and their patients, and the results are especially remarkable given the complex medical conditions and extreme frailty of this population."

In the U.S. Pivotal Trial, the CoreValve System also achieved exceptional hemodynamics, or blood flow, post-implant with results similar to the gold standard, surgical valves. Additionally, valve leakage (known as paravalvular leak or PVL) rates were low and decreased over time as the self-expanding valve conformed to the shape of a patient's annulus - an improvement that has not been reported in other major TAVR studies.

The CoreValve System was developed to serve the needs of the broadest range of patients with severe aortic stenosis. The FDA approved the entire CoreValve platform including the CoreValve Evolut(TM) 23mm, and the CoreValve 26mm, 29mm and 31mm valves. With the broadest size range available, the CoreValve System is suitable for patients with native valves of nearly all sizes. Its self-expanding nitinol frame enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement. All valve sizes are delivered via the smallest (18Fr, or 6mm) TAVR delivery system available, making it possible to treat patients with difficult or small vasculature.

"The FDA approval of CoreValve System is important for U.S. heart teams as the CoreValve System will serve the broadest spectrum of aortic stenosis patients who are unable to undergo surgery," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. "By leveraging Medtronic's history and expertise in bringing therapies to patients, we are supporting heart teams through training and education, imaging and patient evaluation programs that exemplify our safe and deliberate approach to patient access."

Since obtaining CE (Conformité Européenne) Mark in 2007, the CoreValve System has been supported by Medtronic's deep TAVR expertise obtained through more than 50,000 implants outside the U.S.

For the High Risk Study of the CoreValve U.S. Pivotal Trial, which is comparing the CoreValve System to traditional open heart surgery, the FDA determined it will conduct a separate review of the data.

For more information about the CoreValve System, call 877-526-7890 or go to

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

[1] As presented at Transcatheter Cardiovascular Therapeutics (TCT 2013 Conference, CORE VALVE EXTREME RISK: A Prospective Study of Transcatheter Aortic Valve Replacement with a Self-Expanding Transcatheter Heart Valve in Patients with Severe Aortic Stenosis - Jeffrey J. Popma

Reported by Burt Cohen, January 17, 2014