COLORADO SPRINGS, Colo., Sept. 10, 2014 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced that data from EXCITE ISR will be presented as a late-breaking clinical trial at the 26th Transcatheter Cardiovascular Therapeutics (TCT) conference taking place in Washington, D.C., September 13-17, 2014. Eric J. Dippel, MD, will present clinical findings on EXCITE ISR: A Prospective, Randomized Trial of Excimer Laser Atherectomy Versus Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis. Spectranetics will also be hosting a symposium to review the findings – Novel Indication for Treatment of ISR: The Right Path is Clear.
Late-Breaking Clinical Trials – EXCITE ISR: A Prospective, Randomized Trial of Excimer Laser Atherectomy Versus Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis.
- Date: Tuesday, September 16
- Time: 11:40 a.m.
- Room: Main Arena IV – Level 3, Ballroom
Novel Indication for Treatment of ISR: The Right Path is Clear
- Date: Tuesday, September 16, 2014
- Time: 1:00 p.m. – 2:00 p.m.
- Room: Presentation Theater 1
Evolution of the AngioSculpt® Scoring Technology & Development of a Drug-Coated Scoring Balloon
- Date: Monday, September 15, 2014
- Time: 7:00 a.m. – 8:00 a.m.
- Room: Washington Convention Center, Room 146A
FDA 510(k) clearance of Spectranetics' peripheral atherectomy products, Turbo-TandemTM and Turbo-EliteTM, for the treatment of ISR was achieved on the heels of the EXCITE clinical findings. The study is the first large multi-center, prospective randomized trial ever conducted for the treatment of FemPop ISR, demonstrating highly superior safety and efficacy of laser atherectomy with adjunctive PTA (also known as balloon angioplasty) compared with PTA alone.
TCT attendees will be able to experience Spectranetics' full portfolio of vascular intervention products, including Turbo-Tandem, Turbo-Elite and AngioSculpt, as well as the industry's only on-site digital simulator and interactive training, in Booth 1665.
Spectranetics recently acquired AngioScore, Inc., a leading developer, manufacturer and marketer of cardiovascular specialty balloons. Please visit Booth 1224 for a full portfolio of balloon scoring products.
Exhibit Hours
Sunday, September 14:
9:00 a.m. – 5:00 p.m. Exhibit Hall Open
Monday, September 15:
9:00 a.m. – 5:00 p.m. Exhibit Hall Open
Tuesday, September 16:
9:00 a.m. – 2:00 p.m. Exhibit Hall Open
About EXCITE ISR
The EXCITE ISR trial was designed to enroll a maximum of 318 subjects at up to 40 sites, randomized 2:1 treatment to control with predetermined statistical analyses at 200, 250 and 300 enrolled patients. Earlier this year, Spectranetics announced success of the trial based on achieving highly significant statistical superiority in both safety and efficacy among 250 patients. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone. The primary efficacy endpoint is freedom from TLR through six months. The primary safety endpoint is freedom from major adverse events (MAEs) at 30 days. MAEs include all-cause mortality, major amputation in the target limb, or TLR.
About PTA
PTA, also known as balloon angioplasty, is a minimally invasive procedure used to open blocked or stenosed blood vessels. A balloon catheter is placed at the blockage site and inflated to compress the blockage against the vessel wall. While PTA tends to be a temporary solution, it is considered the standard of care for patients with stenosis, a narrowing of the blood vessels in the leg due to PAD, or restenosis, a recurrence of a blockage following treatment. When a stent is used and restenosis occurs, ISR can develop.
About Spectranetics
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are sold in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.
Spectranetics recently acquired AngioScore, Inc., a leading developer, manufacturer and marketer of cardiovascular, specialty balloons.
The Company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee as well as the AngioSculpt® scoring balloon used in both peripheral and coronary procedures. The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
The Lead Management (LM) product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.