A Medical Device Daily

Boston Scientific (Natick, Massachusetts) said it has received CE-mark approval for use of its Taxus Liberté paclitaxel-eluting coronary stent system in patients with diabetes.

The company said it submitted data showing that the Taxus Liberté drug-eluting stent (DES) has benefited diabetic patients with coronary artery disease, both in clinical trials and real-world registries.

Boston Sci said this approval means the Taxus Liberté stent system now has more CE mark-approved indications than any other drug-eluting stent, allowing treatment of a wide range of patients, including many of those at high risk. It said the system is the most frequently used drug-eluting stent system in Europe.

“Achieving CE-mark approval for Taxus Liberté in patients with diabetes is an important milestone,” said David McFaul, senior VP international. “We are offering another specific solution for diabetic patients outside the U.S., who are typically at higher risk for adverse events compared to non-diabetic patients.”

Combined data from four Taxus ATLAS trials supported the efficacy and safety of the DES system in diabetic patients. The trials examined 1,529 patients treated with the Taxus Liberté stent system, 413 of whom had diabetes, and reported similar rates of target lesion revascularization (TLR, or retreatment), cardiac death, myocardial infarction and stent thrombosis (clotting) between diabetic and non-diabetic stent recipients after adjustment for differences in risk at baseline.

Boston Scientific said diabetes affects more than 200 million people worldwide and is expected to affect 360 million people by 2030. Roughly half of all patients presenting with coronary artery disease (CAD) in Europe have diabetes.

Diabetic patients with CAD often have poorer outcomes after revascularization procedures because their blood vessels tend to build up more plaque than the vessels of non-diabetic patients and their CAD advances more quickly. CAD is the most common cause of death among European adults with diabetes, according to the company’s statement.

Boston Sci said that as a result of the expanded CE mark, the Taxus Liberté stent system is indicated in the European Union for treatment of de novo and restenotic lesions or total occlusions in patients with coronary artery disease – angina, silent ischemia, acute myocardial infarction – to improve luminal diameter and reduce restenosis within the stent and at the stent edges in native coronary arteries.

The DES system also is indicated for patients with concomitant diabetes mellitus as well as treatment of abrupt or threatened closure in patients with failed interventional therapy.

The Taxus Liberté stent is available outside the U.S. in a range of sizes to treat a diversity of vessel sizes and lesion lengths seen in patients with coronary artery disease.

The system is pending approval by the FDA.

Sandvik to acquire Medtronic plant in Memphis

Sandvik Materials Technology (Sandviken, Sweden) has entered into an agreement with Medtronic (Minneapolis) concerning the acquisition of a manufacturing plant that specializes in medical instruments for spinal surgery.

The plant is in Memphis, Tennessee, home of Medtronic Sofamor Danek. The acquisition is expected to be concluded in 1Q08.

The Memphis plant will complement Sandvik’s existing expertise and product offering, the company said. It will continue to supply Medtronic as part of a long-term supply agreement.

Sales from products produced at the facility amount to about SEK 140 million ($20 million), the number of employees there totaling 110. Through the acquisition, Sandvik said it strengthens its position in the important and rapidly expanding medical segment.

“The acquisition is in line with our long-term ambition to be a strategic partner within the medical area and a complete supplier to globally leading medical technology companies,” said Peter Gossas, president of Sandvik. “Through the acquisition of Medtronic’s Memphis plant, we extend both expertise and capacity in the field of spinal surgery, which complements our offering within the medical area.”

Sandvik is a global industrial company with products and leading positions in selected areas – tools for metal cutting, machinery and tools for rock excavation, stainless materials, special alloys, metallic and ceramic resistance materials as well as process systems.

Sandvik is a business area within the Sandvik Group and a maker of value-added products in advanced stainless materials, special alloys, metallic and ceramic resistance materials, as well as process plants.

1st Parkinson’s blood test is study goal

DiaGenic (Oslo, Norway) reported that the Michael J. Fox Foundation for Parkinson’s Research (MJFF; New York) is funding a DiaGenic study with Clemens Scherzer, MD, assistant professor of neurology at Brigham and Women’s Hospital (Boston) and Harvard Medical School (Boston), to develop the first-ever blood test for Parkinson’s disease.

The gene expression signature test for the early detection of Parkinson’s involves the identification and independent validation of a unique gene expression signature for Parkinson’s using peripheral blood, DiaGenic said.

Over the past three years, Scherzer and colleagues have established the Harvard PD Biomarker Study, funded by MJFF, designed for discovery and validation of blood tests for Parkinson’s disease.

Because blood samples already have been collected, the company says it can immediately start on the analytical and bioinformatics studies. This will ensure the “rapid development of a prototype blood test followed by an approved diagnostic test for early detection of Parkinson’s disease,” DiaGenic said.

Erik Christiansen, CEO of DiaGenic, said that the study would be based on results from the company’s pilot study on Parkinson’s.

Support from MJFF will secure the initial funding of the project, which involves analyzing samples from the Harvard PD Biomarker Study U.S. cohort to find a common gene expression signature. This signature is then incorporated into a test on a standard platform, combined with DiaGenic’s analysis software.

Parkinson’s will now form the third disease in the portfolio, the company noted, along with Alzheimer’s disease and breast cancer.

DiaGenic says it is focused on developing “new and more patient-friendly methods for early detection of diseases.”