A Medical Device Daily

Spectranetics (Colorado Springs, Colorado) reported the first use in Japan of its Spectranetics Laser Sheath (SLS II) technology for removal of cardiac leads. The company said the SLS II approval by the Ministry of Health, Labor and Welfare is one of just three medical device technologies chosen annually under a fast-track review in Japan.

The SLS II uses "cool" ultraviolet light to safely, effectively and efficiently ablate scar tissue that holds problematic leads in place. A circle of fibers that emit pulses of energy travels over the cardiac lead to dissolve scar tissue that binds the lead to the body. Once the scar tissue is dissolved, the lead can be safely removed. Spectranetics is also in the process of seeking approval of the Lead Locking Device (LLD) technology in Japan, which can be used to assist removal with the SLS II by transmitting traction on the lead from within its hollow inner structure.

This technology has been used in the U.S. and Europe for more than a decade in some 45,000 procedures and is an important tool, Spectranetics said, in managing lead-related issues that may arise in the roughly 4 million pacing and defibrillation leads implanted annually in patients worldwide.

Two procedures were performed recently at Tokyo Women's Medical University by Morio Shoda, MD, chief of clinical cardiac electrophysiology and associate professor of cardiology, and Satoshi Saito, MD, assistant professor of cardiovascular surgery. Both cases involved leads that were infected, and all leads were successfully removed from the heart and encapsulating scar tissue using the SLS II Laser sheath without complication.

Shoda said, "Now ... we can safely address the needs of many patients with implantable pacemakers and defibrillators without subjecting them to more invasive surgical procedures."

Roger Carrillo, MD, director of surgical electrophysiology at the University of Miami, who served as a proctor during the procedures, said, "In this first case in Japan, the laser sheath was successful in extracting a chronic lead where all other techniques had previously failed."

Spectranetics CEO John Schulte said, "Japan is an important market for Spectranetics and the recent fast-track approval for our SLS II Laser Sheath is a key first step toward commercialization, supported by our distribution partner, DVx Japan."

He said the company would launch the technology commercially following reimbursement approval, which is currently under review by the Ministry of Health, Labor and Welfare.

Expanded indication for Cypher Select Plus

Cordis (Warren, New Jersey) reported receipt of CE-mark approval to market the Cypher Select Plus sirolimus-eluting coronary stent for the expanded indication of treating acute myocardial infarction (AMI), or heart attack.

The company said approval for the expanded indication for the Cypher Select Plus stent "provides physicians with another option for treating this serious cardiac event."

It said that more than 150,000 percutaneous coronary interventions are performed for heart attacks every year in Europe.

The expanded indication for the stent in the EU is based on several scientific publications providing clinical evidence for this indication, particularlly data from TYPHOON, the first randomized, multi-center clinical trial to study the safety and efficacy of the Cypher DES in patients who suffered a heart attack.

Cordis said that results from the TYPHOON trial indicated that the Cypher stent reduced the risk of target vessel failure (TVF) by almost half in patients who suffered a heart attack compared to those who were treated with a bare-metal stent — 7.3% for the Cypher stent vs. 14.3% for the BMS arm. TVF is a composite of the need for re-treatment (target vessel revascularization or TVR), recurrent heart attack and death due to cardiac reasons.

The overall mortality rate in both the Cypher stent arm and the BMS arm was low — 2.2% in each.

"No other drug-eluting stent has this level of clinical data support in the setting of primary angioplasty for AMI," said Christian Spaulding, MD, professor of cardiology at Assistance Publique-Paris University Hospitals (Paris) and lead author of the TYPHOON study.

"More than 3,000 patients have been included in nine randomized trials to assess the safety and efficacy of the Cypher Select Plus in AMI. All of these studies have demonstrated significant reductions in the occurrence of repeat revascularization at one year with no increase in stent thrombosis, death or repeat myocardial infarction. Long-term follow-up has also demonstrated that these results are sustained," he said.

The TYPHOON trial was conducted at 48 sites across Europe, Israel and Australia.

Israeli firm gets U.S. angiogenesis patent

Optimata (Ramat Gan, Israel) reported receiving U.S. patent No. 7,418,374, titled "Treatment protocol generation for diseases related to angiogenesis."

The patent protects a system and methods for modeling diseases which relate to angiogenesis processes, and optimization methods to predict improved treatment regimens. Angiogenesis is a key in the progression of different diseases such as solid tumor cancers, cardiovascular diseases, hematological disorders, and macular degeneration.

The company said the potential to block tumor growth and metastases by angiogenesis inhibition "represents an intriguing therapeutic strategy for the treatment of cancer." It said there are currently "an unprecedented number of anti-angiogenic drugs in clinical trials – some 683 open interventional studies, according to the listings of the U.S. National Institutes of Health.

The patent covers optimization methods and systems relating to mathematical models of angiogenesis, which include pro-angiogenesis and anti-angiogenesis components, the regulatory factors vascular endothelial growth factor, platelet-derived growth factor, angiopoietin 1, angiopoietin 2 and others.

Optimata's technology incorporates simulation of the process of vessel maturation and related development processes, as well as the effects of a drug or a combination of drugs on each of the model components and on the outcomes for disease progression.

The company said the technology "can generate a plurality of treatment regimens and select improved treatments [that] can be applied to streamline the development of new drugs and to repurpose anti-angiogenic drugs whose development was suspended."