Terumo Launches Self-Expanding Peripheral Stent to U.S. Market

The U.S. stent market recently became a bit more crowded.

Terumo Interventional Systems has introduced Americans to the Misago RX Self-expanding Peripheral stent, a system that consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter. Designed and developed in Japan, it now is available to treat U.S. patients with peripheral artery disease in the superficial femoral artery (SFA) and/or proximal popliteal artery.

The Misago stent has been available outside of the United States since 2008 and has been studied in more than 5,000 patients in numerous clinical trials. The U.S. Food and Drug Administration (FDA) granted Terumo premarket approval for the device in May this year. The FDA’s 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 superficial femoral and proximal popliteal arteries. In one of the first Harmonization by Doing 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, M.D., and chief primary investigator for the international trial.

Data from the OSPREY study demonstrated the following:

• The flexible design offers a low potential for stent fracture. In the OSPREY trial there was a 0.9 percent 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 percent success in delivering Misago to the lesion site.
• Sustained patency of 82.9 percent as measured at one-year using Kaplan-Meier analysis (PSVR of less than or equal 2.4).
• An 88.6 percent 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, M.D., 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.”

The Misago stent is designed 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 millimeters to 7 millimeters and lesion lengths up to 150 millimeters.

“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 of 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.”

Peripheral Arterial Disease (PAD) affects roughly 8 million Americans, according to industry data. 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 in rare cases, death.

Terumo Interventional Systems, a division of Terumo Medical Corporation, develops minimally invasive entry site management and lesion access technologies. The company offers a product portfolio that includes advanced coronary, peripheral endovascular and urological treatments with strategic initiatives in transradial access, complex coronary intervention and critical limb ischemia. Terumo Medical Corporation is part of Tokyo-based Terumo Corporation, a global medical device manufacturer with more than $5 billion in sales and operations in more than 160 nations.