said Friday that 12-month results for a clinical study evaluating its Talent thoracic stent graft system showed a significantly reduced death rate in patients.
The study compared minimally invasive endovascular stent graft treatment, in which mesh tubes ranging from 22 mm to 46 mm prop open arteries, to a historical surgical control group.
The Minneapolis-based company said patients who received the graft had a statistically significant reduction in death from all causes, 16.1% compared to a control rate of 29.8%. Medtronic said that the system also had a successful aneurysm treatment rate of 89.2%. Furthermore, all of the grafts remained open for proper blood flow, and the company said the study showed a 99.5% success rate in deploying the stent graft.
Medtronic applied for premarket approval from the Food and Drug Administration in March and is awaiting the outcome. The system has been available outside of the U.S. since 1998.
"These results are excellent and demonstrate that the Talent Thoracic Stent Graft provides substantial reductions in all-cause mortality compared to open surgery for this patient population," said Dr. Ronald Fairman, chief of the division of vascular surgery at the University of Pennsylvania Health System and principal investigator for the Talent study. "For patients who are considered candidates for open surgery, this minimally-invasive method may provide a potential treatment option."
Medtronic ended Friday's session up 49 cents, or 1%, at $52.15.