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EXCITE ISR Proves Superiority in Safety, Efficacy of Laser Atherectomy With PTA vs. PTA Alone; Data Presented at TCT 2014

COLORADO SPRINGS, Colo., Sept. 16, 2014 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced that Eric Dippel, MD, at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, presented findings from the EXCITE ISR clinical trial proving Spectranetics' laser atherectomy devices, used with PTA (also known as balloon angioplasty), are clinically superior to PTA alone in both safety and efficacy, triggering a new standard in cardiovascular care.

Eric Dippel, MD, of Genesis Heart Institute in Davenport, Iowa, presented the EXCITE ISR data as part of TCT's Late-Breaking Clinical Trials. TCT is the only platform for first-time presentations of primary endpoint or important secondary endpoint results of prospective, randomized clinical trials with significant impacts in medical treatment. Critical data findings include:

  • 93.5% procedural success rate using Turbo-Tandem with PTA (also known as balloon angioplasty) vs. 82.7% with PTA alone (p = 0.01).
  • Primary safety endpoint, MAE rates at 30 days 5.8% vs. 20.5% with PTA alone (p < 0.001).
  • Primary efficacy endpoint, 73.5% freedom from target lesion revascularization (TLR) at 6 months vs. 51.8% with PTA alone (p < 0.005).
  • Excimer laser atherectomy with adjunctive PTA was associated with a 52% reduction in TLR (Hazard Ratio 0.48; 95% CI 0.31 – 0.74).
  • Dissection rate of 7.7% vs. 17.2% with PTA alone (p = 0.03).
  • Bailout stenting 4.1% vs. 11.1% with PTA alone (p = 0.05).
  • There was no procedurally related stent damage observed in either cohort.

Visit TreatISR.com/Resources for a copy of the EXCITE ISR presentation.

Notably, the study's average lesion length was approximately 20 cm as compared to various stent IDE studies with average lesion lengths of 4 to 6 cm. Additionally, a high number of complex or advanced disease-state patients were enrolled in the trial, indicative of success in treating many types of ISR lesions, including the most complex cases.

The EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal (arteries above the knee) In-Stent Restenosis (EXCITE ISR) is the first large multi-center, prospective randomized trial ever conducted for the treatment of FemPop ISR. In July, Spectranetics received a U.S. Food and Drug Administration (FDA) 510(k) indication of its peripheral atherectomy products, Turbo-Tandem™ and Turbo-Elite™, to treat ISR. Other products are not indicated or contraindicated to treat ISR, uniquely positioning Spectranetics to capitalize on potential market opportunities of $350 million domestically and up to $750 million worldwide.

"Over 200 million people worldwide are afflicted with Peripheral Artery Disease" said Scott Drake, President and CEO of Spectranetics. "This year alone, as many as 400,000 patients around the world will receive stent implants to restore the flow of blood due to complications of the disease. An estimated 30% to 40% of those with stents will develop restenosis. These numbers – as well as patient demand – will continue to grow. The EXCITE trial produced the data that proved safety and efficacy of laser atherectomy to respond to this growing demand."

Once ISR develops, there is a 65% chance of recurrence after treatment with PTA. Each year, up to 250,000 people suffer from ISR globally.

Lead EXCITE ISR investigator Eric Dippel, MD, states, "When it comes to patient care, physicians demand proven results that exhibit superior outcomes, with safety and efficacy as a priority. With 73.5% freedom from TLR at six months versus 51.8% with PTA alone, the data tells the story. The EXCITE results demonstrate that Spectranetics has set a new standard of care for ISR."

Implanting stents to open obstructed blood vessels is an important treatment for patients suffering PAD. While stents deliver improved overall outcomes compared to Percutaneous Transluminal Angioplasty (PTA) treatment, restenosis (a return of the blockage) is very common, and stent re-obstruction or ISR remains therapeutically challenging.

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, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.

For more information, visit www.spectranetics.com.

CONTACT: COMPANY CONTACT The Spectranetics Corporation Guy Childs, Chief Financial Officer (719) 633-8333 INVESTOR CONTACT Westwicke Partners Lynn Pieper (415) 202-5678 lynn.pieper@westwicke.comSource:The Spectranetics Corporation