A Medical Device Daily

Reva Medical (San Diego) reported enrollment of the first patients in a first-in-man clinical trial designed to evaluate the safety of the Reva Bioresorbable Coronary Stent for the treatment of coronary artery disease.

The company said the RESORB (Reva Endovascular Study of a Bioresorbable Coronary Stent) trial would enroll up to 30 patients at multiple sites in Germany and Brazil. RESORB is a non-randomized study with an initial assessment of major adverse cardiac events (MACE) at 30 days and a follow-up period of five years. A second trial is planned to study the safety of the Reva Paclitaxel-Coated Bioresorbable Stent in an additional 30 patients.

Principal investigator Eberhard Grube, MD, of the HELIOS Heart Center Siegburg (Siegburg, Germany), performed the first implants.

“Bioresorbable stents offer great promise for the future treatment of cardiovascular disease,” Grube said. “They may be an ideal solution to recent concerns regarding incomplete healing and late-stage thrombosis in stent patients.”

The Reva Stent is intended to act as a temporary scaffold to support the blood vessel during the healing process. Once the vessel has healed, the stent is designed to resorb, leaving the patient free of a permanent implant. In pre-clinical studies, Reva said its stent geometry and proprietary polymer “have demonstrated mechanical performance similar to metal stents and sustained biocompatibility.”

Dr. Robert Schultz, company president, said, “We’ve applied novel design and biomaterials solutions to create what we believe is a significant advancement in bioresorbable stent technology.”

In 2004, Reva established a strategic relationship with Boston Scientific (Natick, Massachusetts). Hank Kucheman, president of Boston Sci’s Interventional Cardiology Group, said, “We look forward to seeing the results of this trial and to learning more about the potential of this bioresorbable stent technology.”

University, Philips develop CAD for dementia

University Medical Center Hamburg-Eppendorf (UKE; Hamburg, Germany) and Royal Philips Electronics (Amsterdam, the Netherlands) said they have collaborated on the development of a computer-aided diagnosis (CAD) technique for neurodegenerative diseases to support clinicians in diagnosing the onset and type of disease as early as possible.

The new diagnostic technique, which the parties said already has proven its accuracy using historical image data and known patient outcomes, is about to undergo clinical evaluation at UKE.

The CAD system is a software package that automatically interprets PET (positron emission tomography) brain scans of patients suspected of having a neurodegenerative disease that leads to dementia, and combines them with MRI scans for accurate differential diagnosis.

The development of such a system will ultimately mean a better quality of life for patients by enabling earlier prescription of drugs that delay progression of the disease, and hence delay the worst effects of dementia, the companies said. It will also provide pharmaceutical companies and clinicians with a valuable tool for the development and testing of new, potentially curative drugs for neurodegenerative diseases such as Alzheimer’s.

“In the not-too-distant future, there is going to be much greater demand for the accurate early diagnosis of neurodegenerative disease and not everyone will have access to the clinical expertise of a university hospital to obtain it,” said Dr. Ralph Buchert of the department of nuclear medicine at UKE. “The availability of an automated system will help less-experienced physicians to achieve the same high level of accuracy in their diagnoses.”

Dr. Lothar Spies, head of the digital imaging department at Philips Research , said, “Building on our expertise in multi-modal diagnostic imaging, we’ve combined functional and structural brain-scan information into a fully integrated and easy to use system for diagnosing the principal neurodegenerative diseases that cause dementia. Ultimately, it will enable early treatment and highly personalized therapies.”

The software tool developed by Philips Research and UKE accurately overlays anatomical images of the brain obtained from MRI scans with PET scans that display brain activity – specifically the uptake of glucose that fuels brain activity.

By using advanced image processing and computer learning techniques in combination with a database of reference brain-scans, the system then analyses the images automatically and displays anomalous brain patterns in a concise way. Based on these patterns, it then suggests a diagnosis.

The clinical evaluation that is about to start will run the computer-aided diagnostic system alongside the university’s existing dementia-diagnosis procedures, with the aim of fine-tuning the system’s ability to detect and differentiate the three most common types of neurodegenerative disease – Alzheimer’s disease, Lewy-body dementia and frontotemporal dementia.

CE mark for electrotherapy devices

Ivivi Technologies (Northvale, New Jersey) said it has received CE mark certification for the commercialization of certain of its electrotherapy devices, in the member countries of the European Union, for use in the promotion of wound healing, reduction of pain and post-operative edema.

André DiMino, co-CEO of Ivivi, said CE-mark approval “supports our strategy of establishing channel partnerships with global medical device and healthcare companies.”

Ivivi’s electrotherapy devices consist of a signal generator and applicator and are programmed to provide therapy at optimal intervals throughout the course of therapy.

The company said a recent study conducted at Akademikliniken Hospital (Stockholm, Sweden) by Dr. Per Heden “reinforced clinical data that shows the ability of Ivivi’s technology to enhance post-surgical pain management.”

Preliminary data from a randomized double-blind, placebo-controlled clinical study titled “Effect of Pulsed Electromagnetic Fields on Post-Surgical Pain Reduction for Breast Augmentation” showed an 80% acceleration in pain relief in patients treated with the active technology as compared to patients treated with placebo units.

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