Spectranetics’ EXCITE ISR Clinical Findings Published in Journal of the American College of Cardiology Cardiovascular Interventions

The Spectranetics Corporation announced that the Journal of the American College of Cardiology Cardiovascular Interventions (JACC CI), one of the most highly cited and influential journals in the area of cardiovascular medicine, has published findings from Spectranetics’ EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal (the arteries above and behind the knee) In-Stent Restenosis (EXCITE ISR).
 
EXCITE ISR is the first large multi-center, prospective randomized trial ever conducted for the treatment of FemPop ISR., proving Spectranetics’ laser atherectomy devices, Turbo-Tandem™ and Turbo-Elite™, 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.
 
JACC CI publishes studies that impact the practice of interventional cardiovascular medicine including clinical trials that provide evidence to inform and alter practice guidelines and experimental studies that point to improved technologies and mechanistic understanding.
 
The mission of the American College of Cardiology, which publishes JACC CI, is to transform cardiovascular care and improve heart health. The College is a 47,000-member medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers. The College is a leader in the formulation of health policy, standards and guidelines.
 
In July, Spectranetics, headquartered in Colorado Springs, Colo., received U.S. Food and Drug Administration (FDA) 510(k) clearance of their peripheral laser atherectomy products for the treatment of ISR.
 
JACC CI publishes primary endpoint or important secondary endpoint results of prospective, randomized clinical trials with significant impacts in medical treatment. EXCITE ISR’s critical data findings include:
 
·         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).
·         93.5% procedural success rate using Turbo-Tandem with PTA (also known as balloon angioplasty) vs. 82.7% with PTA alone (p = 0.01).
·         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.
 
According to Kim Bridges, Senior Vice President, Vascular Intervention Sales and Marketing at Spectranetics, “Publication of the EXCITE ISR trial in JACC CI solidifies the rigor that FDA clearances represent. We believe that the inclusion of EXCITE ISR speaks volumes to the impact its findings will have on the treatment of ISR,” states Bridges. “The EXCITE ISR data is powerful, and we expect it will change clinical practice, set a new standard in care and dramatically impact patient outcomes.  Spectranetics is enthusiastic to share EXCITE ISR insights with physicians as laser technology makes its mark on cardiovascular health.”
 
Over 200 million people worldwide are afflicted with Peripheral Artery Disease.  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. Once ISR develops, there is a 65% chance of recurrence after treatment with PTA. Treating afflicted patients uniquely positions Spectranetics to capitalize on potential market opportunities of $350 million domestically and up to $750 million worldwide.
 
Lead EXCITE ISR investigator Eric Dippel, MD, states, “JACC is the industry gold standard in presenting research and findings related to superior practices for interventional cardiologists.  Physicians want proven clinical data that drives improved outcomes.  EXCITE ISR is the only atherectomy level one data demonstrating superior results.”
 

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.
 
In June, Spectranetics 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.