A BB&T

As part of its push to grow its presence in the neurosurgical market, Renishaw (Wotton-under-Edge, UK) has acquired, for an unspecified cash consideration, a 75% stake in Schaerer Mayfield NeuroMate, based in Switzerland, and its wholly-owned subsidiary, Schaerer Mayfield NeuroMate Sarl (Lyon, France), a manufacturer of surgical robots for neurosurgery.

"This investment is an important step for Renishaw, Schaerer Mayfield NeuroMate and surgical robotics more generally," said David McMurtry, Renishaw's CEO/chairman. "The combination of the pre-eminent stereotactic robot and the portfolio of neurological products that Renishaw is developing based on its precision engineering capabilities, will provide the neurosurgeon with the tools necessary for precise placement of current and next generation therapeutic delivery devices."

According to the company, the NeuroMate image-guided surgical robot has been used in more than 9,000 neurosurgical procedures, including deep brain stimulation, motor cortex stimulation, stereo electro-encephalography, neuro-endoscopy, radiosurgery, biopsy, and transcranial magnetic stimulation.

It is the world's only such robot with both FDA approval and European CE mark for stereotactic neurosurgery, along with a CE mark for neuro-endoscopy applications. The robot also is approved in Japan.

Renishaw said the growth of precision-guided neurosurgery is set to drive further growth in the robot-assisted surgery market.

"As demands for increased accuracy, safety and efficiencies are required and clinical needs continue to multiply, the prospect of expanding the success of NeuroMate in France, where there is a proven installed base, to other markets, represents a great opportunity," the company said in reporting its purchase of the majority ownership share.

Renishaw said its existing neurological portfolio and investment plans in its stereotactic product line, combined with its commitment to this new technology, will enable it to shape what it termed "this significant market opportunity," providing neurosurgeons with improved clinical outcomes and overall efficiency.

The company noted that it already is involved in "cutting-edge" drug delivery activities and neurosurgical planning enhancement technologies, and the acquisition of Schaerer Mayfield NeuroMate and its robotic expertise "will provide a platform technology for these activities, advance the use of functional neurosurgical procedures and reduce clinical complication rates in existing stereotactic procedures."

Renishaw specializes in the manufacture of precision metrology and inspection equipment, which is sold to a broad range of industrial sectors. In the year ended June 30, the company had revenues of 201.2 million. The Renishaw Group has some 50 locations in 30 countries, with more than 2,200 employees.

Middle East added to territory for Catania

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

The Catania system is CE-marked and available 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 November'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%. 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."

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 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.

Sorin Group releases new CRT-D system

Sorin Group (Milan, Italy) reported the commercial market release and first implant of its new-generation Paradym CRT 8750 cardiac resynchronization therapy defibrillator (CRT-D).

The company said that, together with the new Situs BW 28D left ventricle pacing lead and lead delivery system, Paradym CRT forms a completely new CRT system for heart failure patients.

Paradym CRT is designed to allow more flexibility in the management of cardiac resynchronization and anti-tachyarrhythmia therapy in heart failure patients, thanks to its Brady-Tachy Overlap (BTO) feature.

Guidelines for heart failure management recommend exercise training as part of the treatment for HF patients, as it has been shown to reduce mortality and improve quality of life. With BTO, Paradym CRT is able to provide bi-ventricular resynchronization therapy at the elevated heart rates necessary to support patients' exercise.

HF patients often present slow ventricular tachyarrhythmias (slow VT) at the same elevated rates. Paradym CRT is designed to recognize and treat slow VTs without compromise to resynchronization therapy.

"The physical activity of the patient is definitely a key component to take into consideration when treating every heart failure patient," said Dr. Christian Butter, head of the cardiology department at Heart Center Brandenburg (Berlin, Germany). "Paradym CRT offers my heart failure patients the significant benefit of delivering resynchronization therapy during sustained exercise, while detecting and treating slower ventricular tachycardias without programming constraints."

Butter implanted the first Paradym CRT device in a 38-year-old woman.

Sorin noted that for heart failure patients, it is crucial that life-saving therapies are delivered only when necessary, to avoid a decrease in the patient's quality of life. It said Paradym CRT features the PARAD+ detection algorithm, "whose superior specificity in discriminating ventricular arrhythmias has been clinically proven."

Whenever a shock is needed, Paradym delivers it swiftly with an energy level of up to 37J (42 J stored), the highest available in the market. "This will give maximum assurance to both patients and clinicians in the treatment of life-threatening arrhythmias," Sorin said.

Fred Hrkac, president of the CRM business unit at Sorin, said, "[The] Paradym CRT ... device provides patients the highest delivered energy available on the market to date in a small and long-lasting device. With Paradym CRT, patients have the opportunity to exercise, while arrhythmias at all different rates can be accurately treated."