• Biophan Technologies (Rochester, New York), a developer of next-generation biomedical technology, reported plans to begin animal trials of its advanced MRI-imageable vena cava filter, in a research program underway at the company's newly established Biophan-Europe division. The company's vena cava filter enables physicians to use MRI to see inside the filter to determine if any clots or other materials have been trapped inside the filter, a capability almost impossible under X-ray visualization. This is currently the only filter that can be placed under MRI guidance, allows visualization of captured substrates, and subsequently removed. Biophan said the trials are expected to begin within the next quarter. The company's researchers intend to perform long-term studies on farm pigs, expected to last from 28 to 90 days. The research program is being conducted in cooperation with the University of Essen and the University of Aachen, both in Germany.

• Boston Scientific (Natick, Massachusetts) said it completed enrollment in its three-year Enteryx Procedure clinical trial, a post-approval trial designed to analyze "real-world" clinical outcomes, safety data and efficacy of the Enteryx Procedure for gastroesophageal reflux disease (GERD) symptoms. The trial has enrolled more than 300 patients at 28 U.S. sites. The Enteryx Procedure was FDA-approved in April 2003. Interim results, released at last November's annual meeting of the American College of Gastroenterology, supported safety and efficacy at two years. "We continue to see significant relief of GERD symptoms in patients who have undergone the Enteryx Procedure," said Yang Chen, MD, the study's principal investigator and chief of endoscopy and gastrointestinal practice director at the Anschutz Centers for Advanced Medicine, University of Colorado Hospital. Enrolled in the trial are patients who have responded to and required daily treatment with proton pump inhibitors. "We are confident that the three-year trial will confirm the Enteryx Procedure is an attractive treatment option for patients who suffer from GERD symptoms and seek an alternative to daily medication," said Steve Moreci, senior vice president and group president, endosurgery at Boston Scientific.

• IVMD (Inverness, Scotland) reported the results of recent clinical trials conducted in connection with its labor prediction device. When used in the home by healthy pregnant women, it was found to provide an overall prediction of the onset of normal labor from 14 to seven days in advance. The company said independent studies have shown that the uterus spends time, before the actual birth, getting ready for the labor process and IVMD's predictive technology interprets this physiology with a small electrode system placed on the abdomen and an electronic recording device. Expectant mothers record electrical activity from the uterus for 10 minutes every day from 30 weeks on. The signals detected can be used to predict the onset of labor. These trials, undertaken with 60 women in the UK, were concluded in October 2004. IVMD Chief Science Officer Patricia Connolly said the results "give a clear indication that we can measure the changing physiology of the uterus and create a predictive tool. . . . and from future analysis, there may be other parameters that can make our system even more accurate."

• Medwave (Danvers, Massachusetts) said that a study recently published in the American Journal of Emergency Medicine compared readings taken with Medwave's Vasotrac non-invasive sensor-based blood pressure monitor against the "gold standard" invasive arterial catheter and a traditional oscillometric blood pressure cuff. The study showed that Medwave's Vasotrac monitor provided advantages over both. Separately, Medwave reported that it has released its new enhanced OEM module developers kit, which allows medical device manufacturers to sample the Medwave blood pressure technology in a development setting without investment in engineering resources or time.

• Millstone Medical Outsourcing (Fall River, Massachusetts), a provider of aftermarket solutions for medical device manufacturers, launched three inventory management services designed for quickly redeploying existing inventory. The company's new offerings target three emerging aftermarket opportunities with immediate business value: repackaging, reprocessing and field inventory auditing. The company said three of the top five orthopedic manufacturers, including Stryker (Kalamazoo, Michigan), have begun to work with Millstone Medical to optimize field inventory, reduce labor costs and deliver better value to hospitals and other medical institutions. Shannon Tillman, president of Millstone Medical Outsourcing, said "Our reprocessing and repackaging services cut costs for everyone, increase OEM margins and reduce time to market when compared with manufacturing a replacement part from scratch."

• MIV Therapeutics (Vancouver, British Columbia), a developer of next-generation drug-eluting coatings that inhibit the rejection of implanted medical devices, reported the completion of pilot preclinical studies of hydroxyapatite (HAp) coated stents in pig coronary arteries. The histopathology studies that followed angiographic and intravascular ultrasound evaluation confirmed excellent biocompatibility and safety of its proprietary hydroxyapatite (HAp) coating for vascular applications. The 28-day safety study was performed on four different formulations of MIVT's biocompatible Hap nano-film coating specifically designed for cardiovascular stents, vascular applications, and use in a range of other implantable medical devices. Stents coated with MIVT's coating demonstrated superb safety and healing properties when implanted in pig coronary arteries.