A Medical Device Daily
Medtronic (Minneapolis) has reported the start of an international study comparing its Endeavor Resolute zotarolimus-eluting coronary stent with Abbott's (Abbott Park, Illinois) Xience V everolimus-eluting coronary stent.
The first implants in the RESOLUTE III All-Comers Trial took place in Europe during the last two weeks.
The teams of Stephan Windecker, MD, of University Hospital Bern in Switzerland, one of three principal investigators in the trial, and William Wijns, MD, of the Cardiovascular Centre Aalst in Belgium, enrolled the first patients in RESOLUTE III.
Drs. Sigmund Silber, of the Heart Catheterization Centre (Munich, Germany), and Patrick Serruys, of the Heartcenter (Rotterdam, the Netherlands), are the trial's other principal investigators.
RESOLUTE III is the pivotal trial for the Endeavor Resolute drug-eluting stent and one part of the overall RESOLUTE clinical program. RESOLUTE III will randomize roughly 2,300 patients, in a one-to-one manner, to the Endeavor Resolute or Xience stent at 15 to 20 international medical centers in countries where both stents are commercially available.
The primary endpoint for RESOLUTE III is target lesion failure, a composite of cardiac death, myocardial infarction and target lesion revascularization, at one year.
The Endeavor Resolute stent received CE-mark approval in October 2007 and is commercially available in more than 100 countries outside the U.S.
The stent uses a new biocompatible polymer called BioLinx, which is designed to confer the same biocompatibility as the Endeavor stent's phosphorylcholine polymer while extending the duration of drug exposure in the vessel.
Developed by Medtronic scientists, BioLinx is the first polymer created specifically for use on a drug-eluting stent, taccording to the company.
1st distribution agreement for Acrobot
Acrobot (London), a company focused on computer-assisted surgery, has signed an exclusive distribution agreement with Corin Group for certain key markets, including the UK, Germany and Australia.
Under the terms of the agreement, Corin has exclusive distribution rights in these markets for the Acrobot Navigation system for hip resurfacing procedures. Corin will purchase systems from Acrobot and market them through its own in-country sales infrastructure.
Acrobot said the agreement will enable more customers to access its Navigation system — technology that is now usable in a wider range of procedures, including uni-condylar knee and total hip replacements.
The arrangement is Acrobot's first commercial route-to-market agreement.
CEO Graeme Brookes said, "Our excellent relationship with Corin, a leader in the hip resurfacing field, has played a fundamentally important part in enabling us to bring our systems to market. The relationship with Corin was instrumental in the initial development of the Acrobot Navigation system, and this coupled with the strength and reach of Corin's sales infrastructure provides excellent opportunities for both parties."
He added that the company was "pleased to have now formalized our commercial relationship with Corin."
Corin CEO Peter Huntley said, "The Acrobot system enables surgeons to plan and perform Cormet hip resurfacing surgery with a level of precision that was not possible before. This system gives us a competitive advantage in the hip resurfacing field in some of our major markets, and we are looking forward to working closely with Acrobot to promote this innovative technology."
Tecan in U. of Zurich collaboration
Tecan (Durham, North Carolina) said it is collaborating with tissue engineering researchers at the University of Zurich in Switzerland to develop a novel, automated system for propagation of quality controlled cells that will be suitable for use in regenerative medicine therapies, such as intervertebral disc implants.
The project is funded by the Swiss innovation promotion agency, CTI.
Tecan said its new solution will control all necessary cell culture steps, including the isolation, seeding, proliferation, harvesting and analysis of cell lines and primary cells. Quality control will be maintained through two integrated detection devices that will determine the degree of cell confluence and detect the expression of cell type-specific genetic markers.
"I'm convinced that regenerative medicine through tissue engineering will become a clinical reality, but to reach our goals we urgently need automated cell culture systems focused on repeatability, robustness and data traceability," said Professor Norbert Boos, head of spinal surgery at the Orthopaedic University Hospital Balgrist, University of Zurich.
"For example," he said, "cell-based nuclear replacement of the intervertebral disc seems a feasible and minimally invasive treatment for discogenic back pain, but the approach will not succeed without highly sensitized, automated tissue culture. We are certain that Tecan has the know-how and the infrastructure to achieve our goals and we have had an excellent partnership so far."
Tecan is a global supplier of laboratory instruments and solutions for the biopharma, forensic and diagnostic industries, specializing in the production and distribution of automation solutions for life science laboratories.
Founded in Switzerland in 1980, the company has production, research and development sites in both North America and Europe.
New Portugal office for Chiltern
Chiltern (London), a global research organization, reported the opening of a new office in Lisbon, Portugal, headed by Ricardo Diaz as country manager. Diaz has more than 10 years' experience in clinical research.
The office is staffed with clinical research professionals, supporting Chiltern's ongoing clinical studies in Portugal. The company said that in addition, its Resourcing Solutions brand provides local sponsors with the opportunity to bring on board "well-trained personnel, based at either clinical sites or the sponsors' offices, on short or long-term contracts."
"Chiltern continues to invest in expanding our geographic footprint to support our sponsors' demands," said Lewis Cameron, executive vice president Europe. "Quick patient enrollment and the small number of competitive trials add to the overall benefits of in running clinical studies in Portugal."