Healthcare Industry News:  peripheral artery disease 

Devices Interventional

 News Release - January 13, 2010

Published Study Demonstrates Effectiveness of Spectranetics Turbo-Booster(R) for Peripheral Artery Disease

CELLO Study Demonstrated Significant Reduction in Artery Blockage Following Excimer Laser Ablation with Turbo-Booster(R) with no Major Adverse Events

COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--Spectranetics Corporation (NASDAQ: SPNC ) today announced publication of the CELLO (CLiRpath Excimer Laser System to Enlarge Lumen Openings) study, which evaluated the effectiveness of excimer laser ablation with the Turbo-Booster, for patients with peripheral artery disease (PAD), in the December issue of the Journal of Endovascular Therapy. The FDA-cleared laser treatment met its primary endpoint by reducing, on average, the percent diameter stenosis from 77.3 percent to 42.5 percent immediately post Turbo-Booster use, easily exceeding the goal of a 20 percent difference. Additionally, the Turbo-Booster had a low number of repeat vascular interventions, while safely improving a range of clinical and functional status assessments.

The CELLO study is a prospective, 17-center study that enrolled 65 patients with claudification, or walking impairments caused by PAD. Direct laser ablation was performed on above-the-knee arteries— the superficial femoral and popliteal arteries— that were at least 70 percent blocked. It is common for these patients to require frequent revascularization of the target artery blockage. However, the CELLO study demonstrated that 76.7 percent of patients did not require revascularization procedures one year post-treatment. Additionally, treatment demonstrated a strong safety profile, with no major adverse events through the six-month follow-up period.

PAD is a widespread condition affecting about eight million Americans, with most incidences occurring above the knee. Left untreated, PAD can lead to ulcers that do not heal, gangrene and even amputation.

“Preventing the millions of leg amputations caused by PAD represents an urgent medical imperative,” said Dr. Rajesh Dave, principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital in Harrisburg, Pa. “The best way to preserve limbs is by creating larger blood vessel cavities, also known as the lumen. This study demonstrated the Turbo-Booster’s ability to produce larger lumens than what was previously achieved by excimer laser catheters alone. This may help reduce the need for aggressive adjunctive therapy, like stenting.”

Excimer laser ablation procedures are typically prescribed in combination with conventional therapies, such as balloon angioplasty and stents. While adjunctive therapies remain an important part of the PAD treatment toolkit, the CELLO trial demonstrates that the Turbo-Booster may reduce the need for stent use above the knee. For instance, only 23 percent of the study population required them. A significant proportion of the non-stent subpopulation, 74 percent, did not need revascularization within one year.

Improving the Quality of Life for PAD Patients

More than half of PAD sufferers experience leg pain, numbness or other symptoms—making it difficult to walk more than several hundred yards or perform other day-to-day activities. The CELLO study demonstrated durable objective and subjective functional improvements post-procedure, demonstrating the treatment’s sustained ability to help patient’s return to normal daily activities:

  • Walking impairment questionnaire (WIQ): Based on this standard patient self-reported assessment, scores increased from 45.6 to 65.1—a significant improvement in patients’ perceived mobility.
  • Ankle-brachial index (ABI): This objective test, which assesses the ratio of blood flow to the ankle compared to the arm, significantly increased from 0.78 to 0.90 after one year.
  • Rutherford category: This physician-assessment score improved significantly from 2.4 to 1.3 over 12 months.

“The CELLO study demonstrates the Turbo-Booster’s durable quality-of-life benefits, for a devastating disease in which there are no current treatments that can reverse its progression,” said Emilie J. Geisenheimer, Chairman, President and Chief Executive Officer of Spectranetics. “For this patient population, enhancing quality of life and reducing the need for repeat vascularization procedures represents significant progress. Spectranetics is committed to advancing the delivery of laser ablation, so that it can optimally benefit PAD sufferers via a minimally invasive approach.”

The CELLO study served as the basis for the 2007 FDA clearance of the Turbo-Booster, which offers an enhancement over prior laser ablation techniques. The Turbo-Booster assists the Turbo Elite(R) laser catheter in delivering excimer laser energy to more of the target lesion. By rotating the laser catheter within the blood vessel, the Turbo-Booster enables ablation of more plaque than is possible with the catheter alone.

Spectranetics is the only company to develop FDA-cleared, excimer laser ablation procedures for PAD. The treatments deliver pulsed bursts of ultraviolet (UV) energy that vaporize blockages into tiny particles easily dissolved into the bloodstream. In contrast to the long recovery time required for bypass surgery, the excimer laser ablation procedure is performed within one to two hours with only minutes of laser time, followed by one to two days of recovery. Patients typically experience very little, if any, discomfort during the procedure.

About Spectranetics

Spectranetics manufactures and markets the only CVX-300(R) Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. More than 800 Spectranetics laser systems are used in hospitals worldwide.

The Company's Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.

The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.

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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 adverse results of the FDA and Immigration and Customs Enforcement investigation, adverse results of the securities litigation or the stockholder derivative litigation in which the Company or any of its officers or directors is a party, insufficient insurance coverage or the denial of insurance coverage related to legal costs or any settlement or judgment in connection with those proceedings, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which, among other things, affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital and has rendered our investments in auction rate securities illiquid, market acceptance of excimer laser atherectomy technology, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development 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, adverse outcome of FDA inspections, the receipt of FDA approval to market new products or applications, and the timeliness of any approvals, market acceptance of new products or applications, including the VisiSheath Dilator Sheath, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with the Company’s relocation and consolidation of its manufacturing operations, and 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.

Source: Spectranetics

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