A Medical Device Daily

A milestone in the imaging of Alzheimer’s Disease (AD) has been reached through a collaboration between radiochemists from the University of Pittsburgh and GE Healthcare (Waukesha, Wisconsin). The University of Pittsburgh has started a study aimed at obtaining preliminary information on the performance of flourine-18 labeled Pittsburgh Compound B (F-18 PiB) to identify amyloid deposits in subjects with a diagnosis of AD.

Chet Mathis, a professor of radiology at the University of Pittsburgh School of Medicine and director of the PET Facility at UPMC said, “early results are encouraging and we look forward to the larger multi-site trials that GE Healthcare will perform with F-18 PiB in early 2007.”

The imaging of brain amyloid by carbon-11 PiB has been judged by Nature Medicine to be one of the most significant advances in the field of AD in recent years. Multiple sites have now replicated the landmark studies reported by Klunk et al in Annals of Neurology in 2004. More recently the Alzheimer’s Association (Chicago) and GE have funded a C-11 PIB add-on study to the Alzheimer’s Disease Neuroimaging Initiative, a $60M study to determine the value of brain imaging.

Although C-11 PiB can be used for academic studies, the 20-minute half-life of C-11 and limited manufacturing access means the molecule is not suitable for widespread use as a routine diagnostic agent. F-18, with a half-life of 110 minutes, offers a much better opportunity for manufacturing and distribution.

In 2003, GE Healthcare licensed a number of compounds from the University of Pittsburgh. Proof of concept studies have already been performed in collaboration with GE Healthcare’s IMANET organization, leading to the selection of the lead candidate for further research. Subsequent work has focused on producing the F-18 PiB material to the quality standards necessary for clinical trial use.

GE Healthcare provides products and services intended to help healthcare providers better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier.

In other agreements news:

• Wyndgate Technologies (Denver), a division of Global Med Technologies, reported that Hospital Partners of America (HPA; Charlotte, North Carolina) is implementing Wyndgate’s SafeTrace Tx transfusion management system at St. Joseph’s Medical Center (Houston). St. Joseph’s Medical Center is the second facility operated by HPA to implement Wyndgate’s transfusion management system. Terms of the agreement were not disclosed.

HPA first licensed the SafeTrace Tx system for its Twelve Oaks Medical Center (Houston). When St. Joseph’s Medical Center learned that it would need to purchase a new blood bank system because its existing system was being discontinued, HPA licensed SafeTrace Tx based on the success and satisfaction with the system at Twelve Oaks Medical Center, Wyndgate said.

“SafeTrace Tx has been installed at Hospital Partners of America’s Twelve Oaks Medical Center for over two years now and we have been very happy with its performance. SafeTrace Tx provides comprehensive management and tracking of patients and blood products, including many built-in safety features. Our past experience has proven that Wyndgate Technologies is a solid, reliable company and that SafeTrace Tx is a quality system,” said Cheryl Cook, corporate director of application services for Hospital Partners of America.

Hospital Partners of America develops and operates physician-partnered hospitals throughout the country. Global Med Technologies provides information management software products and services to the healthcare industry. Its Wyndgate Technologies division supplies information management systems to U.S. and international blood centers and hospital transfusion centers.

• Medical Device Consultants (North Attleboro, Massachusetts) and Boston Healthcare Associates (BHA; Boston) have signed a preferred vendor agreement.

Medical Device Consultants, a regulatory consulting firm and contract research organization specializing in helping medical device manufacturers understand and overcome the regulatory challenges of launching and maintaining medical devices in the U.S. and European markets, will join forces with Boston Healthcare Associates, an advisor to life science companies, helping clients develop and implement marketing and reimbursement strategies to gain market access, and secure payer reimbursement.

Medical Device Consultants and BHA will work together to deliver the collaborative benefits of each firm’s regulatory and reimbursement solutions, and will recommend each other’s complementary services. The two organizations will pursue joint opportunities and support each other’s marketing efforts.

The Beaumont Technology Usability Center (BTUC; Royal Oak, Michigan) has entered into a partnership with GE Healthcare (Waukesha, Wisconsin) to improve the safety and ease of use of the medical technologies produced by the company. The engineers and clinical staff of the BTUC will assist the manufacturer through collaborative product development, usability testing and human factors engineering.

The first collaborative design effort of the two companies is to advance a telemetry monitoring system, a medical device designed to monitor patients’ vital signs and trigger an alarm when a critical arrhythmia is detected. The staff at BTUC is working with GE to increase the intelligence of the telemetry alarm algorithms and improve the equipment’s user interface. With these improvements, GE’s product will advance the standard of patient care.

The BTUC is a multidisciplinary team of health care experts affiliated with Beaumont Hospitals. GE Healthcare provides a variety of products and services intended to help clinicians predict, diagnose, inform and treat disease.

• Nextrials (San Ramon, California) said it has established a partnership with Vitalograph (Buckingham, United Kingdom) to offer researchers expedited access to pulmonary function data collected during clinical trials. By integrating Nextrials’ Prism clinical trial management system with the Vitalograph Spirotrac Centralized Spirometry System, pharmaceutical, biotechnology and medical device researchers can more quickly evaluate patient pulmonary function data and monitor the changes in lung capacity or function that may occur during a clinical trial, thereby improving patient safety, Nextrials said. Real-time access to study data also means improved workflow and better overall efficiency within an investigational study, resulting in reduced costs and time to market for new therapies, according to Nextrials.