Medtronic to develop stent graft system for endovascular repair of thoracoabdominal aortic aneurysms under exclusive patent license agreement with Sanford Health

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Collaboration aims to expand treatment options, improve outcomes for patients

Patrick Kelly, M.D.

We hope that this will have a major impact on the treatment of one of the most challenging disease processes to face our specialty.

The global leader in medical technology for endovascular aortic repair (EVAR), Medtronic plc (NYSE: MDT) today announced that it plans to develop a stent graft system for less invasive treatment of thoracoabdominal aortic aneurysms under an exclusive patent license agreement with South Dakota-based Sanford Health.

A concept for the novel system, which was described in the November 2014 issue of the Journal of Vascular Surgery, is currently being studied (NCT02294435) under a physician-sponsored (PS) investigational device exemption (IDE) recently approved by the U.S. Food and Drug Administration (FDA). Sanford Health vascular surgeon Patrick Kelly, M.D., the physician sponsor of the PS IDE, developed the concept for the system and has since collaborated with Medtronic to manufacture devices based on the concept.

Sanford Health holds the intellectual property covered by the exclusive patent license agreement with Medtronic. Medtronic plans to study the system in collaboration with physicians at several medical centers, including Kelly at Sanford Health, starting in the near future and subsequently to commercialize it after obtaining the required regulatory approvals.

David Pearce, Ph.D., president of Sanford Research, believes this type of translational research is important to his organization’s mission. “Our culture at Sanford Health and at Sanford Research is one that supports the problem-solving innovation that’s needed to bring medical advancements to market and to patients. Dr. Kelly’s ingenuity is providing a treatment option to patients who may not be eligible for any other approach for repairing their aneurysm,” Pearce said.

Kelly added, “Taking the complex and making it simple has long been our goal for the treatment of thoracoabdominal aneurysms. Working with Medtronic could eventually place our solution in the hands of vascular surgeons around the world to help patients facing a life-threatening condition. We hope that this will have a major impact on the treatment of one of the most challenging disease processes to face our specialty.”

“We’re very excited to be working with Dr. Kelly and Sanford Health to develop a standardized stent graft system to address the clinical challenges of repairing thoracoabdominal aortic aneurysms,” said Daveen Chopra, vice president and general manager of the Aortic franchise at Medtronic. “The exclusive patent license agreement that we’ve entered into with Sanford Health is a further demonstration of how Medtronic collaborates with physicians to foster innovation and develop new therapies that lead to better patient care.”

Medtronic is the long-standing leader in medical technology for endovascular aortic repair. Medtronic stent grafts have been used to treat more than 400,000 patients worldwide since 1999 –– more than those from any other company.

ABOUT AORTIC ANEURYSMS
The aorta is the body’s main artery, originating at the top of the heart’s left ventricle and terminating at the iliac bifurcation in the abdomen. An aortic aneurysm is a dangerous bulge or ballooning in a segment of the wall of the aorta that can rupture and cause sudden death if left untreated. The condition affects an estimated 1.3 million people in the United States alone.

Aortic aneurysms can be classified by anatomical location, including thoracic, abdominal and thoracoabdominal. Thoracoabdominal aortic aneurysms –– the rarest type, with a U.S. prevalence of several thousand patients –– start in the thorax and extend through the abdomen; they generally involve the branch arteries that supply blood to the liver, spleen, intestine, kidney and other organs, making them especially challenging to treat. Most patients with a thoracoabdominal aortic aneurysm have limited treatment options and are considered at high-risk for open surgical repair.

ABOUT SANFORD HEALTH
Sanford Health (http://www.sanfordhealth.org) is an integrated health system headquartered in the Dakotas. It is the largest, rural, not-for-profit health care system in the nation with 43 hospitals and 243 clinics in nine states and three countries. With 27,000 employees, including 1,400 physicians in more than 80 specialty areas of medicine, Sanford Health is the largest employer in the Dakotas.

ABOUT MEDTRONIC
Medtronic plc (http://www.medtronic.com), headquartered in Dublin, Ireland, 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.

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Stacy Jones
Sanford Health
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