- Both devices also receive reimbursement designation from the Japanese Ministry of Health, Labour and Welfare
- Japan Lifeline Co., Ltd., which supervised the regulatory and reimbursement submissions, will distribute both products in Japan
- Sales in Japan of both devices expected to begin in January
MINNEAPOLIS, Dec. 11, 2013 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that two of its products, the GuideLiner guide extension catheter and the SuperCross FT microcatheter, have received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW). The company expects sales of both devices in Japan to begin during January.
Both GuideLiner and SuperCross FT will be distributed in Japan by Vascular Solutions' distribution partner, Japan Lifeline Co., Ltd., which supervised the pre-market regulatory review and reimbursement process with Japan's MHLW. Both devices have also received reimbursement designation, with reimbursement in Japan expected to be effective January 1, 2014. Stocking shipments of both products to Japan Lifeline are expected in early January followed by full-scale commercial activity later that month.
"While Japanese approvals of both GuideLiner and SuperCross FT had been anticipated, the timeliness of these approvals and the solid reimbursement status that both devices have been accorded give us increased confidence that 2014 will be our 11th consecutive year of double-digit revenue growth," said Howard Root, Chief Executive Officer of Vascular Solutions. "We are grateful to our partner, Japan Lifeline, for its dedication and hard work involved in securing the pre-market approval and reimbursement designation for GuideLiner and SuperCross FT."
GuideLiner is a rapid exchange guide extension "mother-and-child" catheter that is designed to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature and to facilitate placement of interventional devices. GuideLiner received CE Mark and was launched in Europe in October of 2009 and received 510(k) clearance and was launched in the U.S. in November of 2009. "GuideLiner is already Vascular Solutions' largest-selling product, and the approval in Japan will significantly expand the commercial potential for this important interventional device," Mr. Root said. "The highly complex case load of procedures typically performed by interventional cardiologists in Japan makes GuideLiner an important addition to the device options available for challenging cases."
SuperCross FT, the flexible-tip version of Vascular Solutions' line of SuperCross microcatheters, was designed to address the majority of complex interventional procedures in which a flexible-tipped microcatheter is needed to provide superior deliverability over a guidewire in tortuous anatomy. SuperCross microcatheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. The devices may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents. "We view our SuperCross FT as a workhorse microcatheter that is very useful in complex procedures," stated Mr. Root. "We anticipate that SuperCross FT will be well-received by interventional cardiologists in Japan."
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 more than 75 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, 2012 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 more information, connect to www.vasc.com.
About Japan Lifeline
Japan Lifeline Co., Ltd. develops, manufactures, and markets leading-edge cardiovascular-related medical devices. The sales network of the company covers all of Japan, and it has provided products of superior quality to medical institutions for more than 30 years. It focuses in the fields of cardiac rhythm management (CRM), electrophysiology/ablation, cardiac surgery (cardiovascular and endografting), and transvascular intervention. The company not only imports and distributes medical devices from overseas manufacturers to Japan, but also develops and manufactures its own EP catheters, ablation catheters, guide wires, and vascular prostheses.
For more information, connect to www.japanlifeline.com.