Vascular Solutions’ Hemostasis Device Launched in U.S.

Vascular Solutions Inc. has launched the R-Band radial hemostasis compression device in the United States on behalf of the product’s Beijing, China-based manufacturer, Lepu Medical Technology Company Ltd. Vascular Solutions is the exclusive distributor of the R-Band device in the U.S. under an agreement with Lepu Medical.

The R-Band, which has received U.S. Food and Drug Administration 510(k) clearance, is a radial compression device used by interventional cardiologists to achieve hemostasis after transradial diagnostic and interventional catheterization procedures. The device consists of a soft plastic wrist strap with adjustable hook and loop fasteners, two inflatable compression balloons, and an inflation syringe with a proprietary connector tip. After applying the strap around the patient’s wrist, the physician inflates the compression balloons to apply gentle pressure to the puncture site of the radial artery, while maintaining flow through the ulnar artery. The clear plastic strap and clear compression balloons allow the clinician to visualize the access site during the entire process, the company claims.

“R-Band will be an important addition to our product portfolio as we focus on serving the needs of the fast-growing radial artery access market and adding to our hemostat products business segment,” said Howard Root, CEO of Vascular Solutions. “Radial access is undergoing tremendous expansion in the United States, and we are especially pleased that the addition of the R-Band will allow us to offer a broader range of products for radial hemostasis to fit physician preferences, supplementing our existing Rad Band and D-Stat Rad-Band products. In addition, the R-Band provides obvious synergies with the Accumed wrist positioning splint that we acquired in June.”

Vascular Solutions officials report that adoption of radial access has become a priority for many U.S. cardiac catheterization labs (cath labs) due to the importance placed on improved patient comfort, the availability of specialized radial devices and catheters, and the integration of radial access into practice guidelines and physician fellowship programs. According to a study by the Society for Cardiovascular Angiography and Interventions, radial access accounted for under 3 percent of all diagnostic and interventional cardiac cath lab procedures in the United States in 2009. According to research conducted by Vascular Solutions, the company estimates that radial access now accounts for more than 12 percent of all such procedures in the United States, while in Canada the number is closer to 50 percent, and in Europe, 30 percent.

Lepu Medical Technology Company develops, manufactures, and markets cardiac therapy devices. The company’s products include drug-eluting stents, catheters, guidewires, occlusive devices, prosthetic heart valves, pacemakers, and cardiac in-vitro diagnostic products.

Minneapolis, Minn.-based Vascular Solutions provides clinical solutions for coronary and peripheral vascular procedures. The company manufactures catheters and other products used in coronary and peripheral vascular procedures.