Medtronic and Sanford Health announced on 9 February 2016 the first patient enrolled in a clinical study using the Medtronic Valiant thoracoabdominal aortic aneurysm stent graft for minimally invasive repair of thoracoabdominal aortic aneurysms.
The procedure was performed by Patrick Kelly, through a physician-sponsored, investigational device exemption, approved by the FDA. Kelly, a physician and inventor who leads Sanford Vascular Innovations, reports the patient was a 58-year-old female with few alternative medical options for treatment of her aneurysm.
“The mortality rate is 25% when treating a thoracoabdominal aortic aneurysm with an open surgical technique, which involves cutting open the aorta. Providing the patient with an option for a less-invasive approach is needed,” said Kelly. “This procedure marked an important step in the process to obtain FDA approval, and Sanford’s support of such innovation will give hope to patients afflicted with challenging disease states such as this.”
The Valiant thoracoabdominal aortic aneurysm stent graft system is intended to allow for an off-the-shelf endovascular solution to one of surgery’s most difficult pathologies. The device garners broad attention as physicians search for options to treat patients with severe and challenging aortic disease.
“The Valiant thoracoabdominal aortic aneurysm approach allows for the procedure to be staged at any time and lets the operator work on each branch vessel individually,” said James Black III, chief of the Division of Vascular Surgery and Endovascular Therapy at Johns Hopkins Hospital. “When taking on challenging cases, the device leverages skill sets that are quite routine for vascular surgeons.”
“The novel device is customisable and diverse,” said Thomas Naslund, chief of the Division of Vascular Surgery at Vanderbilt University Medical Center. “It is critical that our field focus on innovative ways to treat these kinds of aneurysms.”
“As the first patient treated with the minimally invasive Valiant thoracoabdominal aortic aneurysm recovers, we are inspired by the innovators that continue to challenge the limitations of current treatment options,” said Daveen Chopra, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. “Our mission to improve patient outcomes will drive us into the future as we seek to treat more complex aortic disease.”
A concept for the novel Valiant thoracoabdominal aortic aneurysm system was first described in the November 2014 issue of the Journal of Vascular Surgery. Kelly developed the concept for the system and has since collaborated with Medtronic. 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 centres, including Kelly at Sanford Health.