A Medical Device Daily

Researchers at Yale School of Medicine (New Haven, Connecticut) and more than 60 collaborating research sites have received a $33 million grant from the National Institutes of Neurological Disorders and Stroke (NINDS; Bethesda, Maryland) to conduct a multi-center trial examining a novel approach for treating patients with stroke.

The Insulin Resistance Intervention after Stroke (IRIS) trial will study the effectiveness of a commonly prescribed medication, pioglitazone, for preventing recurrent stroke and myocardial infarction among non-diabetic patients with a recent ischemic stroke and insulin resistance.

The IRIS trial represents an approach to stroke prevention, addressing insulin resistance, a common, but often unrecognized risk factor. Insulin resistance may lead to diabetes, stroke and myocardial infarction.

By some estimates, insulin resistance affects up to 50% of stroke patients. Pioglitazone reduces insulin resistance and is currently approved for use in diabetes treatment, but it has not been tested for prevention of vascular disease in non-diabetic patients.

More than 400,000 Americans survive an ischemic stroke each year. Despite current treatment, within four years of the initial event, 16% of stroke patients will have a recurrent stroke and 9% will have a myocardial infarction, the researchers said.

“Prevention of further vascular events, therefore, is of major importance,“ said principal investigator Walter Kernan, MD, associate professor of medicine at Yale School of Medicine.

The IRIS trial includes more than 60 research centers in the U.S. and Canada that will recruit 3,136 participants in the next three years. Eligible participants are men and women age 45 or over without diabetes who have insulin resistance and a recent ischemic stroke.

The participants will be randomly assigned to pioglitazone or placebo in addition to their usual therapy. “We have designed the trial to test the hypothesis that pioglitazone will reduce the risk of recurrent stroke or heart attack by 20% during four years of therapy,“ said Kernan.

NuVasive relocates and expands

NuVasive (San Diego), a company focused on developing products for minimally disruptive surgical treatments for the spine, reported its relocation to an expanded facility to accommodate future growth and the demand for surgeon education and training on its spine surgery.

The three-story, leased building is located in San Diego and triples the company's available space to 62,367 square feet. The facility provides additional capacity to accommodate the warehousing and distribution of products, instrument sets and implants. It also triples NuVasive's fabrication capabilities for instrument prototyping and it enhances the company's Absolute Responsiveness program to customers by providing custom features to their specifications.

The facility houses an expanded cadaver operating theater comprised of six surgical suites for the training of surgeons and sales representatives. The operating theater has been equipped with surgical and technological advancements, ensuring the most accurate and precise training experience using the company's MAS platform.

Illumina in pact with Mayo Clinic

Illumina (San Diego) announced an agreement with the Mayo Clinic (Rochester, Minnesota) for the purchase and installation of an Illumina BeadLab at Mayo's Rochester location. The BeadLab, a production-scale genetic analysis laboratory, will be used for research into the genetics of cancer and other complex diseases.

While focused initially on SNP genotyping and the analysis of genetic variation, Mayo's researchers said they expect to use the BeadLab for a range of integrated genetic studies, including whole-genome and focused gene expression for the analysis of biological and metabolic pathways. The BeadLab will be available to Mayo Clinic investigators at all three Mayo Clinic sites (Jacksonville, Florida; Scottsdale, Arizona; and Rochester).

The BeadLab is an end-to-end genetic analysis solution built around Illumina's proprietary BeadArray technology and featuring extensive automation, parallel sample throughput, high-multiplex assay protocols, low running cost per sample and industry-leading performance. When installed, the new BeadLab at the Mayo Clinic will have the capacity to produce routinely 1 million genotypes per day.

The BeadLab also will support gene expression profiling of large sample sets and new methods such as Illumina's DASL assay for profiling of degraded RNAs from formalin-fixed, paraffin-embedded samples.

New name for Advanced Photometrics

Advanced Photometrics (Pleasanton, California), a supplier of micro-infrared spectroscopy analyzers to OEMs, said it has changed its name to Aspectrics as the company moves to launch its technologies into various chemical analysis and monitoring markets.

“We are enthusiastic about this corporate milestone,“ said CEO Paul Salsgiver Jr. “Our new company name effectively communicates our position in the market as providers of innovative chemometric analyzers at the most critical aspects of processes.“

The Aspectrics technology platform is based on a form of infrared spectroscopy, called encoded photometric infrared spectroscopy (EP-IR). At the heart of the EP-IR analyzer is a rotating disc onto which up to 256 concentric encoding tracks is formed. The EP-IR analyzer continuously acquires data on every optical channel in parallel to provide the most accurate intensity measurements.

“The encoding tracks of the EP-IR analyzer replace the detector elements of a conventional detector array, eliminating artifacts arising from dead or drifting detector elements,“ Salsgiver said. “The EP-IR analyzer effectively offers Nondispersive Infrared ruggedness with Fourier Transform Infrared performance.“