Medtronic (NYSE:MDT) this week presented data from 2 studies of its stent systems and announced a new study of its In.Pact Admiral drug-coated balloon. The announcements were made at the VIVA physicians annual conference in Las Vegas, Nev.
The Fridley, Minn.-based medical giant presented data from a 2-year clinical trial of its Valiant Captivia thoracic stent graft system for treating type B aortic dissections, reporting safety and efficacy at 2-years.
Data from the 2-year follow up of the 35-patient FDA approved IDE trial reported no post-index procedure ruptures or conversions, device related adverse events or loss of stent graft integrity or collapse.
At 24-months, true-lumen diameter in the stented region remained stable or increased in 85.7% of patients, false-lumen diameter remained stable or decreased in 78.6% . The study reported that false lumen was partially or completely thrombosed in 70.4% of patients, Medtronic said.
“There is a growing body of evidence supporting the use of thoracic endovascular aortic repair as a safe and effective treatment for patients with acute type B aortic dissections. The Valiant Captivia system has continued to produce positive patient outcomes at 2 years,” Dr. Ali Azizzadeh of the University of Texas Health Science Center said in a prepared statement.
Medtronic presented data from a 9-month trial comparing the use of self-expanding stents and balloon expanding stents for treating peripheral artery disease in patients with a “diverse range” of symptomatic iliac atherosclerotic diseases.
The study compared the company’s Protege EverFlex self expanding stent, Protege GPS self-expanding nitinol stent and delivery system and Visi-Pro balloon expanding stent systems.
The study reported that at 9 months, the rate of major adverse events was 1.3% for the self-expanding stents and 4% for the balloon-expanding stents. Patency rates between groups were similar at 95.8%, the company reported.
Medtronic also announced the initiation of the Reality study to evaluate the adjuctive use of directional atherectomy and drug-coated balloon treatments for patients with symptomatic peripheral arterial disease. The study will focus on treating long, calcified lesions in the superficial femoral artery or popliteral artery, and is sponsored and will be managed by VIVA physicians.
The multi-center, prospective observational angiographic and duplex ultrasound core lab adjucated study looks to enroll 250 subjects at 20 sites across the U.S. Primary patency will be measured by duplex ultrasound at 12-months, and patients will be followed to 2-years, the company said.
The study will also include sub-analyses, such as looking at intravascular ultrasound assessments of directional atherectomy procedures to debulk plaque morphologies, including severe calcium in long lesions prior to DCB deployment, the company said.
“As standalone treatments for peripheral arterial disease, directional atherectomy and DCBs have demonstrated strong clinical results. However, challenges in treating long and severely calcified femoropopliteal lesions remain including the associated provisional stent rate with DCB and reintervention rates with directional atherectomy over the long-term. The Reality study was driven by the need to look at a viable treatment paradigm that combines the use of directional atherectomy and DCB therapy to address these challenges,” Prairie Heart Institute CSO Dr. Krishna Rocha-Singh said in a press release.