CORRECTION: Due to inaccurate information provided, an earlier version of the story stated that the Valiant Thoracic Stent Graft System is available in the U.S and Europe. While it is approved domestically, it has yet to launch commercially.
Medtronic Inc. (NYSE:MDT) reported positive clinical trial data on its Valiant Thoracic Stent Graft System at the one-year patient follow-up in the company’s U.S. pivotal study, according to data presented at a meeting for vascular surgeons on Saturday.
The stent graft system is a minimally invasive treatment for thoracic aortic aneurysms. Such aneurysms are life-threatening bulges in the body’s main artery near where it branches off the heart. Patients whose aneurysms rupture typically die. About 15,000 people are affected by thoracic aortic aneurysms each year, according to the Cleveland Clinic. Those aneurysms that are detected before rupturing and/or are large can be treated with stent grafts or invasive surgery.
The results from the clinical trial show that mortality was 12.6 percent, with only 3.3 percent of deaths deemed aneurysm-related. Nearly all patients (97.4 percent) achieved 12-month successful aneurysm treatment, and very few stent grafts (2.9 percent) migrated from their original placement. The study also met its clinical endpoints.
“Through 12 months, there were no cases of rupture or conversion to open surgery,” said principal investigator Dr. Ronald Fairman, chief of the division of vascular surgery and endovascular therapy at the Hospital of the University of Pennsylvania, in a statement. “Overall, treatment results were quite promising.”
The Valiant Thoracic Stent Graft System is approved in both the U.S. and Europe, said Medtronic spokesman Joseph McGrath. The Valiant Thoracic Stent Graft on the Captivia Delivery System is sometimes called the Valiant Captivia Thoracic Stent Graft System and is the “market-leading stent graft for the minimally invasive treatment of thoracic aortic aneurysms outside the United States.” It is expected to launch in the U.S. in the fall.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The product is part of Medtronic’s endovascular group. In the May 24 conference call to discuss fiscal fourth-quarter results, CFO Gary Ellis said that the business segment saw a 20 percent jump in revenue to $165 million. In Europe, the Valiant Captivia Thoracic Stent Graft System helped to gain market share in the thoracic market, Ellis noted.
