COLORADO SPRINGS, Colo., June 4, 2014 (GLOBE NEWSWIRE) -- A presentation by principal investigator Eric J. Dippel, MD, of Genesis Heart Institute in Davenport, Iowa, at the annual New Cardiovascular Horizons (NCVH) conference in New Orleans last week demonstrated significant procedural advantage of laser atherectomy in the largest randomized trial of atherectomy ever conducted.
The EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis (EXCITE ISR) showed a 93.5% procedural success rate with laser atherectomy plus PTA (also known as balloon angioplasty) for the treatment of ISR versus 82.7% with PTA alone.
These findings, which are confirmed by an independent core lab and currently under FDA review, represent the first randomized, multi-center clinical trial results demonstrating the benefits of atherectomy in ISR. Study results also show a lower major dissection rate (2.4% vs. 7.4% with PTA alone) and additional stenting (4.7% vs. 13.6% with PTA alone).
According to Amanda Johnson, Vice President of Regulatory and Medical Affairs for The Spectranetics Corporation, which sponsored the study, "It is remarkable to see these superior clinical outcomes, affirming the exceptional performance of laser atherectomy. This is critical to elevating the current standard of care for patients suffering from peripheral artery disease (PAD). The findings generate new insights and more complete evidence to enable physicians to determine which treatment options are best for their patients."
"Notably, the average lesion length was nearly 20 cm in both arms, indicative that this was a true real- world study as opposed to some of the stent IDE studies with average lesion lengths of four to six cm," Dr. Dippel pointed out. "In addition, approximately three times as many patients in the laser arm presented with severe calcification as compared to the angioplasty arm."
In-stent restenosis (ISR) occurs when a previously placed stent becomes occluded, or blocked, and is considered to be a challenging condition to treat. Spectranetics designed this treatment-to-control trial to show safety and efficacy of treatment with laser atherectomy in patients with ISR.
About EXCITE ISR
The EXCITE ISR trial was initially designed to enroll a maximum of 318 subjects at up to 35 sites, randomized 2:1 treatment to control. Earlier this year, Spectranetics announced early 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 40 countries and are used to treat arterial blockages in the heart and legs, and the removal of pacemaker and defibrillator leads.
The Company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee. 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 and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.