A Medical Device Daily

Stereotaxis (St. Louis) said the commercial launch of its partnered magnetic irrigated catheter will begin this week at centers in Europe. The company said its decision to release the magnetic irrigated catheter for commercial use was made following its strong performance in a recently concluded external evaluation.

During the external evaluation, clinicians at nine centers in Europe and Canada performed 92 procedures with the magnetic irrigated catheter, some 75% of which were complex left-sided procedures.

Stereotaxis said the catheter "exceeded all clinical end points tested during this evaluation period." Additionally, mean time to complete mapping and ablation was 20% below documented manual times, and the catheter demonstrated an exceptional safety profile.

"Our goal is to create a new standard of care for complex EP ablations," said Stereotaxis President/COO Mike Kaminski.

Dr. Gerhard Hindricks, of Herzentrum Leipzig (Leipzig, Germany), said, "We were among the first to see [the catheter's] clear clinical advantages. Having now performed additional cases since its re-introduction, we're delighted by its performance relative to navigation and lesion formation and we're very excited to participate in its commercial release."

Dr. Karl Heinz-Kuck, of St. Georg Allgemeines Krankenhaus (Hamburg, Germany), said, "Its superb maneuverability provides precise positioning even at sites difficult to reach within the heart, and together with the catheter's stability this led to a high success rate."

"We are confident that the launch of the magnetic irrigated catheter in Europe will be followed by the U.S. launch, which will result in a significant increase in Niobe utilization rates that will drive our future commercial momentum," said Kaminski.

CEO Bevil Hogg said the company has seen "significant momentum in our overall position in Europe this year, both in terms of systems placed and orders, and this is clearly centered on improvements in utilization around the use of the irrigated catheter. We expect demand will climb as the magnetic irrigated catheter is launched beyond the initial nine commercial sites."

Stereotaxis makes an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis system is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guide wires through the blood vessels and chambers of the heart to treatment sites.

This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guide wire, resulting, the company said, "in improved navigation, shorter procedure time and reduced X-ray exposure."

Quality Incentive consultation launched in UK

Proposed changes to the Quality and Outcomes Framework (QOF), the UK's general practitioner (GP) quality incentive effort, are focused on delivering the best possible care for patients and addressing health inequalities, said Health Minister Ben Bradshaw.

The QOF rewards GP practices for managing some of the most common chronic diseases such as diabetes or heart failure, improving health, organizing practices well, how patients view their experience at the surgery, and the quality of extra services offered such as child health and maternity services.

Under new proposals set out in a public consultation published late last month, the National Institute for Health and Clinical Excellence (NICE) would in the future oversee the annual process of reviewing clinical indicators. Beginning in April 2009, NICE will review the benefits to patients and the cost-effectiveness of the indicators used to assess the quality of care provided by GP practices.

NICE also would be responsible for developing a more transparent and inclusive review process with input from patients and caregivers, primary care professionals and other stakeholders.

The final choice of QOF indicators would remain a matter for negotiation with the British Medical Association, based on the advice produced by NICE.

The 12-week consultation is seeking views on how the new process for assessing evidence for QOF indicators should work.

Bradshaw said, "We have come a long way in addressing health inequalities, thanks to the current GP scheme for quality incentives and the UK leads the world in providing incentives to GPs to improve quality of care for patients.

"The latest figures for the Quality and Outcomes Framework show that practices have continued to deliver improvements in services for patients," he said. "But we want to ensure that GP practices continue to deliver more improvements to patient care, and the system needs to evolve to support practices in achieving even better outcomes for patients."

1st distributors signed by Nansonics

Nanosonics (Alexandria, Australia) said it has appointed its first exclusive distributors in Europe, located in Germany, Austria, Switzerland, Italy, France and Scandinavia.

According to Nanosonics' Director and CEO David Radford, this represents the achievement of another key milestone in the commercialization of the company's launch product, the Trophon EPR, scheduled for March 2009.

Trophon EPR is designed to disinfect intracavity and surface ultrasound transducers. The product represents Nanosonics' first commercial application of one of its core technologies, the NanoNebulant technology.

The company said that, compared to existing disinfection solutions, the Trophon EPR marks the beginning of a new level of disinfection: High Level Disinfection, including sporicidal efficacy.

"We feel that there is strong demand for this unique product in ultrasound and infection control markets worldwide," Radford said. "The critical success factor will be the adoption of quality standards that provide for high level disinfection of ultrasound transducers."

He added, "We are planning to overcome these challenges through beneficial cooperations with outstanding distribution partners in each country. The dealer contracts signed in Europe already commit a considerable increase well above our internal sales projections and consumables from these device sales will provide a secondary ongoing revenue stream."