(VASC) Receives Shonin Approvals to Launch GuideLiner
- 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 — 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.
CONTACT: Vascular Solutions, Inc. James Hennen, CFO JHennen@vasc.com (763) 656-4352 Phil Nalbone, VP-Corp. Dev. PNalbone@vasc.com (763) 656-4371
TraderPower Featured Companies
Top Small Cap Market News
- $SOBR InvestorNewsBreaks – SOBR Safe Inc. (NASDAQ: SOBR) Closes on $8.2M Private Placement
- $CLNN InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces Participation at Two Upcoming Investor Conferences
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
Recent Posts
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
Recent Comments
Archives
- October 2024
- January 2023
- June 2022
- December 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- August 2019
- July 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- November 2018
- October 2018
- September 2018
- August 2018
- July 2018
- June 2018
- May 2018
- April 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009