SOMERSET, N.J., June 18, 2015 /PRNewswire/ -- Terumo Interventional Systems will introduce the MISAGO® RX Self-expanding Peripheral Stent to the U.S. market at the 2015 Society for Vascular Surgery Annual Meeting (SVS), June 17-20, Chicago. The MISAGO stent system consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter. Designed and developed in Japan, it is now available to treat patients in the U.S. with peripheral artery disease in the superficial femoral artery (SFA) and/or proximal popliteal artery.
The MISAGO stent has been available outside of the U.S. since 2008. It has been studied in more than 5000 patients in numerous clinical trials. The U.S. FDA granted premarket approval (PMA) for the device in May. FDA approval was based on submission of one-year data from the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY), a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenosis and occlusions of the SFA. In one of the first Harmonization by Doing (HBD) initiatives between the United States and Japan, the study included patients enrolled in the U.S., Japan, Taiwan and Korea.
"The lack of differences in outcomes among the patients studied supports the validity of multi-national trials which will streamline approvals in different nations and maximize resources while reducing costs. I can foresee future trials which build upon our harmonization study design" said Takao Ohki, MD and Chief Primary Investigator for the international trial.
Data from the OSPREY study demonstrated the following:
- The flexible, durable design offers a low potential for stent fracture. In the OSPREY trial there was a 0.9% incidence of stent fracture per stent at 12 months post-procedure.
- A simplified thumbwheel system allows for precision deployment by a single operator at the lesion site. Physicians in the OSPREY study reported 100% success in delivering MISAGO to the lesion site.
- Sustained patency of 82.9% as measured at one-year using Kaplan-Meier analysis (PSVR of less than or equal 2.4).
- 88.6% freedom from target lesion revascularization, as measured at one-year using Kaplan-Meier analysis.
"The MISAGO stent has a flexible design and good radial force that we found performed well in the superficial femoral artery" said John Fritz Angle, MD., Principal Investigator for the U.S. clinical trial. "Peripheral artery disease can have devastating consequences but we believe the MISAGO stent offers a durable treatment option for superficial femoral artery disease."
On June 17, Dr. Angle presented the results of the OSPREY Study at the SVS Meeting.
"We look forward to partnering with the U.S. interventional medical community to bring the benefits of this novel technology, as well as others in the future, to patients in the U.S.," said Chris Pearson, Vice-President Marketing at Terumo Interventional Systems. "We express our gratitude to all the OSPREY investigators that helped to advance the scientific knowledge of the MISAGO stent."
About the MISAGO Stent
The MISAGO stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the SFA and/or proximal popliteal artery with reference vessel diameters ranging from 4 mm to 7 mm and lesion length up to 150 mm. The product will be available for demonstration at the Terumo Booth #610 throughout SVS. For more information visit www.terumois.com.
Important Safety Information
Do not use this device in patients who exhibit angiographic evidence of severe thrombus in the target vessel or lesion site before/after undergoing Percutaneous Transluminal Angioplasty (PTA) procedure, patients with contraindication to antiplatelet and/or anticoagulation therapy, patients who are judged to have a lesion that prevents proper placement or deployment of the stent, a lesion that is within an aneurysm or an aneurysm with a proximal or distal segment to the lesion, a lesion through which a guide wire cannot pass. This device should only be used by a physician who is familiar with, and well trained in, Percutaneous Transluminal Angioplasty (PTA) techniques and stent implantation.
RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.
Peripheral Arterial Disease (PAD) affects approximately 8 million Americans.1 It is a disease where cholesterol, fatty deposits and/or calcium known as plaque, narrow or block arteries limiting blood flow to the limbs. The result can be leg pain, cramping and difficulty walking. In addition to leg pain, complications of the disease can be more severe and include chronic skin ulceration, gangrene, amputation, infection, and death.
Terumo Interventional Systems (TIS), a division of Terumo Medical Corporation, is a market leader in minimally invasive entry site management and lesion access technologies. TIS offers a complete, solution-based product portfolio used in advanced coronary, peripheral endovascular and urological treatments with strategic initiatives in Transradial Access, Complex Coronary Intervention and Critical Limb Ischemia. TIS combines innovative research and development with a deep market understanding to create a pipeline of industry leading devices that deliver clinical value, economic benefit, and enhanced patient outcomes. Terumo Medical Corporation is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with over $5 billion in sales and operations in more than 160 nations.
SOURCE Terumo Medical Corporation