Sanford Health cardiovascular surgeon Patrick Kelly, M.D., recently was featured in an interview published in Endovascular Today, a publication that covers the latest technology, techniques and developments in the endovascular field.
He gave his perspective on applying for what’s called an investigational device exemption and practicing under it, and interacting with the Food and Drug Administration (FDA).
Combining an inventive spirit, multi-disciplinary expertise and a comprehensive research infrastructure, Dr. Kelly and his team develop and commercialize technologies to provide new surgical solutions and better care options for vascular patients.
From ideas to finished products, Sanford Vascular Innovations has all of the pieces necessary to package new technologies for medical device companies. Inventiveness combined with surgical, clinical, regulatory and reimbursement expertise allow it to create cutting-edge technologies.
Sanford Vascular Innovations was created in 2012. Dr. Kelly and his team of experts have more than 125 issued or pending patents for medical devices designed to improve the field of vascular surgery and endovascular care.
The FDA gave the company approval to study a new device to treat complex aneurysms occurring in the descending aorta, the Unitary Manifold Stent Graft System. Dr. Kelly also developed the concept for the Medtronic Valiant® TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm.
About Sanford Health
Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 43 hospitals and nearly 250 clinics in nine states and four countries. Sanford Health’s 27,000 employees, including 1,400 physicians, make it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford have allowed for several initiatives, including global children’s clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. For more information, visit sanfordhealth.org.