A Medical Device Daily

CeloNova BioSciences (Newnan, Georgia) reported that it has expanded the areas in which it is commercializing its Catania coronary stent system with NanoThin Polyzene-F, a stent system that has not had any stent thrombosis in clinical studies.

The Catania system is CE-marked and available for purchase throughout Europe and now in some Middle Eastern countries, with "aggressive" worldwide expansion ongoing, according to the company.

CeloNova also reported that it has received regulatory approval to increase the shelf life for the stent from two years to three years.

The Catania Polyzene-F surface treatment is an inorganic polymer that confers superior biocompatibility and lubricity to the substrates it coats. The Polyzene-F treated surface is anti-inflammatory, promotes quick and complete vessel healing, reduces peri-operative and post-procedural platelet activation, and helps to prevent tissue reactions that lead to restenosis.

"After having evaluated the Polyzene-F coating many years ago, it is interesting to see this concept coming back with experimental and initial clinical data quite encouraging toward prevention of stent thrombosis," said Antonio Colombo, MD, director of the cardiac cath lab at Columbus Hospital and chief of invasive cardiology at San Raffaele Hospital, both in Milan, Italy, who recently added the Catania stent to his practice.

The one-year data for the first-in-man study presented at last month's Transcatheter Cardiovascular Therapeutics conference shows that at 12 months, in an unusually complex FIM patient population, the results showed zero percent stent thrombosis (Academic Research Consortium, or ARC-defined), death, myocardial infarction, stroke, or coronary artery bypass graft. Target lesion revascularization was 10.9% (only 3.6% clinically driven, 7.3% non-clinically driven), with a binary restenosis rate of 6.8% (five of 74 lesions analyzed at twelve months). Of note, all patients stopped dual anti-platelet therapy after 30 days, but continued aspirin (100 mg/d) throughout the 12-month period.

The acute angiographic and procedural success rate in the ATLANTA Trial was 100 percent. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound data for all patients immediately after stent implantation and at six-month follow-up. Further analysis of 1,904 cross sections (19,028 struts) by investigators using optimal coherence tomography at baseline and again at six-month follow-up in a subset of 15 randomly selected patients revealed complete endothelialization and 99.5% stent strut coverage.

"The Catania stent, while it is superbly engineered to include the highly developed Polyzene-F, is a simple solution to a complex problem," said Thomas Gordy, president/CEO of CeloNova. "It has no drugs, no thick polymeric coating, no substance to artificially stimulate cell growth, and no additives. And it does not force patients to take dual antiplatelet therapies for months on end, further complicating their lives."

CeloNova BioSciences is a developer of medical devices that are then enhanced by Polyzene-F, a highly lubricious, anti-inflammatory and bacterial-resistant surface treatment for implanted devices.

MGuard stent okayed in Israel

In other coronary stent news, InspireMD (Tel Aviv, Israel) reported that its MGuard coronary stent system has been approved for use in Israel by the Israeli Ministry of Health.

The MGuard stent system presents a combination of a coronary stent merged with an embolic protection device. Lifelong embolic protection is achieved by an expandable, flexible fishnet-style, micron-level knit sleeve that wraps the stent.

In addition, MGuard blocks embolic showers and plaque detachment from the arterial wall, blocking debris at the source during and post procedure. The net is designed to diffuse stent pressure on the vessel wall, thereby reducing injury and lowering the likelihood of restenosis.

Since receipt of CE-mark approval in November 2007, the device "has been met with much enthusiasm and celebrated by leading interventional cardiologists worldwide," said InspireMD.

"We are very excited about MGuard being approved for use in Israel so soon," said InspireMD President Dr. Asher Holzer. "Our leading Israeli interventional cardiologists have been eager to have this life-saving stent system available at their hospitals and already in the few days since the local approval, lives of Israelis have been saved with MGuard."

InspireMD marked the launch of MGuard in Israel at this week's ICI '08 meeting in Tel Aviv, where MGuard was demonstrated at the company's booth.

Mexico starts HPV testing program

In a campaign to reduce the most common cancer affecting Mexican women, the Mexican public health agency Secretaria de Salud, or SSA, reported it is launching the first phase of a program that will offer testing for human papillomavirus (HPV), the primary cause of cervical cancer, to low-income women age 35-65.

The cost of the testing will be covered by the agency. In the first phase of the screening program, which began last month, more than 200,000 women in the lowest-income 125 counties of Mexico are being offered the papillomavirus test along with the traditional Pap smear.

In 2009, the pilot program will be expanded to include another 600,000 women in the 20 states with the highest death rate from cervical cancer.

"As in many countries, cervical cancer is the most prevalent cancer in Mexican women between the ages of 15-44," said Peer Schatz, CEO of Qiagen (Venlo, the Netherlands), the company that developed the digene HPV Test, which will be used in the SSA's program and also is the only such test approved by the FDA.

He added, "Every year, more than 12,000 Mexican women are diagnosed with cervical cancer and nearly half of them die. Yet this is an entirely preventable disease."

Noting that the Mexican government "is taking a leadership role in Latin America, and the world," Schatz said, "Qiagen is committed to joining with the SSA to assure that our advanced screening technology is accessible to women everywhere, no matter what their income level or social class."

Infection with the papillomavirus is very common in Mexico. The World Health Organization (Geneva, Switzerland) estimates that 11% of Mexican women carry cervical HPV at any given time.