Vascular Solutions, a medical device company, has obtained Shonin approvals from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its GuideLiner guide extension catheter and the SuperCross FT microcatheter.
Japan Lifeline, the distribution partner of Vascular Solutions, has supervised the pre-market regulatory review and reimbursement process with the MHLW for GuideLiner catheter and SuperCross FT microcatheter.
Japan Lifeline will distribute the two devices, which also received reimbursement designation, in Japan. Reimbursement for the products in Japan is expected to be effective 1 January 2014.
The company is expected to receive both products for distribution in early January 2014 and full-scale commercial activity is expected later January 2014.
Vascular Solutions’ 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
The device obtained CE Mark approval in Europe in October 2009 and 510(k) clearance from the US Food and Drug Administration approval in November 2009.
SuperCross FT is the flexible-tip version of Vascular Solutions’ line of SuperCross microcatheters. The device has been 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.
Vascular Solutions CEO Howard Root noted 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 the company’s 11th consecutive year of double-digit revenue growth.
"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 already Vascular Solutions’ largest-selling product, and the approval in Japan will significantly expand the commercial potential for this important interventional device.
"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."
"We view our SuperCross FT as a workhorse microcatheter that is very useful in complex procedures. We anticipate that SuperCross FT will be well-received by interventional cardiologists in Japan," Root added.
Japan Lifeline is expected to begin selling both devices in Japan in January 2014.