A Medical Device Daily

Medtronic of Canada (Mississauga, Ontario) reported receiving regulatory approval from Health Canada's Therapeutic Products Directorate (TPD) for use of the Endeavor drug-eluting coronary stent (DES) system in the treatment of coronary artery disease. The company said sales of the Endeavor stent in Canada began this week.

About 90,000 stents are implanted in Canadian patients with coronary artery disease each year, according to research conducted by two Canadian cardiology societies.

"Endeavor represents a true next-generation, drug-eluting stent because of its unique design, which combines an advanced stent platform with the potent drug zotarolimus and a biocompatible polymer," said Eric Cohen, MD, director of the cardiac catheterization laboratory at Sunnybrook Health Sciences Centre (Toronto). "This device ... has the advantage of being highly flexible, which permits delivery through tortuous vessels of the coronary vasculature. Having this stent available in Canada provides us with an important treatment option for Canadian patients."

Cardiovascular disease accounts for the death of more Canadians than any other disease: Of the more than 70,000 Canadian deaths annually, some 54% (about 38,000) are due to coronary artery disease, government statistics show.

"The approval of the Endeavor stent in Canada is an important event for patients and physicians," said Neil Fraser, VP of Medtronic of Canada. "It brings a new, next-generation technology to Canada, with a strong history of clinical results that show excellent efficacy and safety."

Medtronic said clinical research has shown that Endeavor provides a "consistent and sustained" reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining "an excellent safety profile."

The Endeavor clinical program includes three randomized controlled trials and four registries. From this program, Medtronic submitted data on more than 4,100 patients to Canada's TPD for review, with follow-up out to as long as four years.

The company said this data "encompasses one of the largest, most wide-ranging populations submitted to the TPD for a drug-eluting stent."

Medtronic also will provide annual updates on its Endeavor post-market clinical registries and trials for a period of five years as a condition of Health Canada's approval, including results under the proposed single-arm, post-approval study involving at least 5,000 patients that Medtronic will be conducting, as well as updates on studies and trials with respect to late stent thrombosis, myocardial infarction, death and optimal dual anti-platelet therapy.

Medtronic of Canada employs more than 400 and has regional offices in Vancouver and Montreal, as well as an education center and a museum in Mississauga.

F&S reviews Brazilian diagnostics market

The consolidation movement in the clinical diagnostics sector is expected to drive escalation of the number of tests for processing, which, in turn, will drive the clinical diagnostics automation market, according to consulting firm Frost & Sullivan (F&S).

New analysis from F&S's Sao Paulo office, "Brazilian Clinical Diagnostics Automation Markets," finds that this market earned revenues of $31 million in 2007, estimating this to reach $49.5 million in 2012.

"Dealing with a massive number of samples is a time-consuming process and implies higher possibilities of error," says Tania Mito, F&S research analyst. "Automation can alleviate this problem by optimizing the use of laboratory resources, resulting in faster and safer processes."

Moreover, Mito said, automation could serve as a significant differentiation factor in a consolidating market. "Automation solutions can optimally use laboratory resources, help standardize procedures, and reduce human involvement," she said. "These competitive advantages will improve quality and speed of services, accuracy of results, and reliability of tests.

"Despite their advantages, budget restraints of the Brazilian healthcare market and the high initial investments required for automation technology has deterred several laboratories from adopting this technology. In addition, end users do not fully appreciate the benefits of reduced labor requirements, since labor costs are extremely low in Brazil."

While reduction of human resources is expected to compensate for the costs of automating laboratories in the U.S. and Europe, the concept of labor cost savings has not caught the fancy of investors in Brazil. F&S said market participants can remedy this situation by promoting automation's long-term benefits such as safer and faster procedures as well as results that are more reliable.

"Automation is an excellent tool for reducing operational costs and enhancing productivity and efficiency. Processing larger quantities of samples and operating on the pre- and post-analytical stages will save costs through reductions in labor force and time, enabling the laboratory to optimize its resources."