Vascular Solutions, Inc. today announced that it has launched the R-Band radial hemostasis compression device in the United States. Vascular Solutions is the exclusive distributor of the R-Band device in the U.S. under an agreement entered into with Lepu Medical Technology (Beijing) Co., Ltd., the developer and manufacturer of the device.
Vascular Solutions will introduce the R-Band to the clinical community at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference this week at the Miami Beach Convention Center in Miami, Florida. The TCT's exhibition hall is open between Tuesday, October 23 and Thursday, October 25, and the R-Band will be one of the products featured by Vascular Solutions in Booth #368.
The R-Band, which has received 510(k) clearance, is a radial compression device that is used by interventional cardiologists to achieve hemostasis following 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.
"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, Chief Executive Officer of Vascular Solutions. "Radial access is undergoing tremendous expansion in the U.S., 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(TM) and D-Stat(R) Rad-Band products. In addition, the R-Band provides obvious synergies with the Accumed wrist positioning splint that we acquired in June."
Adoption of radial access has become a priority for many cardiac catheterization labs in the U.S. due to a growing acceptance of 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 (SCAI), radial access accounted for under 3% of all diagnostic and interventional cardiac cath lab procedures in the U.S. during 2009.
Based on recent market research conducted by Vascular Solutions, it is estimated that radial access now accounts for more than 12% of all such procedures in the U.S. This level of penetration still significantly lags other parts of the world, such as Canada at 50% or the average for Europe of approximately 30%.
About Lepu Medical Technology
Lepu Medical Technology (Beijing) Co., Ltd. was established in 1999 to develop, manufacture, and market medical devices, with a concentration in cardiac therapy. Today, the company's products include drug-eluting stents, catheters, guidewires, occlusive devices, prosthetic heart valves, pacemakers, and cardiac in vitro diagnostic products. In October 2009, Lepu listed on the ChiNext of Shenzhen Stock Exchange.
Lepu has more than 1,000 employees and is headquartered in Beijing's Changping Technology Park.
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company's product line consists of approximately 70 products in three categories: catheter products, hemostat products and vein products. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through its direct U.S. sales force and international independent distributor network.
The information in this press release contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements. Important factors that may cause such differences include those discussed in our Annual Report on Form 10-K for the year ended December 31, 2011 and other recent filings with the Securities and Exchange Commission. The risks and uncertainties include, without limitation, risks associated with the need for adoption of our new products, lack of sustained profitability, exposure to intellectual property claims, significant variability in quarterly results, exposure to possible product liability claims, the development of new products by others, doing business in international markets, the availability of third party reimbursement, and actions by the FDA.
For further information, connect to www.vasc.com.