ELANA - A Novel Laser-Assisted Neurovascular Surgery Technique
Nov 8, 2005 - 3:37:00 PM
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ELANA (Excimer Laser-Assisted Non-occlusive Anastomosis) is the only known technique that enables surgeons to create a vascular bypass without occluding the recipient vessel, allowing continued blood supply during the procedure.
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By Spectranetics Corporation,
[RxPG] Spectranetics Corporation announced today that its strategic partner Elana BV has obtained Communautes Europeennes (CE) mark registration for its laser-assisted neurovascular surgery technique that incorporates a Spectranetics excimer laser and a laser catheter manufactured by Spectranetics.
"The ELANA technique has the potential to assist many patients at risk for stroke where few or no treatment alternatives exist," said John G. Schulte, Spectranetics' president and chief executive officer. "We are delighted with the approval received by Elana BV to begin marketing in Europe, and look forward to supporting their efforts to educate physicians about the potential benefits of this surgical technique."
ELANA (Excimer Laser-Assisted Non-occlusive Anastomosis) is the only known technique that enables surgeons to create a vascular bypass without occluding the recipient vessel, allowing continued blood supply during the procedure. To make the connection for the bypass graft (anastomosis), a platinum implant is attached to the outside wall of the recipient vessel. The end of the bypass graft then is stitched to the wall of the recipient vessel, using the implant as a guide. Next a laser catheter is inserted through the bypass graft to the wall of the recipient vessel, and laser ablation is used to create a hole in the artery wall; the laser catheter removes the disc, enabling blood flow to the recipient vessel.
The ELANA clinical research was performed at four European sites and involved more than 300 cases. Additional clinics are expected to be added soon. The ELANA technique will be commercialized by Elana BV (www.elana.com) and has been used for patients with a giant aneurysm or a skull base tumor and insufficient collateral circulation.
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Additional information about the news article
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Spectranetics and Elana BV, a private company based in The Netherlands, announced their development agreements in October 2004. The agreements provide for Spectranetics to supply laser systems and to develop and supply laser catheters. A cross-licensing arrangement of certain of each company's intellectual property rights also is a part of the agreements.
About Spectranetics
Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Its CVX-300® excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of the company's FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe. In April 2004 Spectranetics obtained 510(k) clearance from the FDA for the laser-based treatment of patients suffering from total occlusions (blockages) in their leg arteries that are not crossable with a guide wire.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include increasing price and product competition, increased pressure on expense levels resulting from expanded marketing and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, the potential size of market opportunities associated with new products, market acceptance of new products or applications, product defects, price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.
Spectranetics and CVX-300 are registered trademarks of The Spectranetics Corporation.
COMPANY CONTACT:
Spectranetics Corporation
John Schulte, Chief Executive Officer
Guy Childs, Chief Financial Officer
(719) 633-8333
www.spectranetics.com
INVESTOR & MEDIA CONTACTS:
Lippert/Heilshorn & Associates, Inc.
Bruce Voss
Don Markley
(310) 691-7100
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