A Medical Device Daily

SpineMark (San Diego), a spine care services organization that partners with hospitals and physicians to develop spine centers and facilitate clinical research, and Wooridul Hospital of South Korea have established an international alliance that they say will leverage and build upon the spine excellence of each organization.

The two organizations said that through this joint venture, they will create centers designed to "advance the development of programs for clinical care, research and medical education to achieve more effective care worldwide for patients who have suffered back injuries."

As part of the alliance, SpineMark and Wooridul will open spine Centers of Excellence, clinical and spine research organizations (SROs) and medical education facilities. They hope to co-establish and manage a clinical research organization that includes SROs in Korea, Shanghai, Singapore, Japan, India and Abu Dhabi.

"Wooridul Hospital is renowned for its state-of-the-art facilities and work in spine treatment research," said Marcy Rogers, SpineMark's president/CEO. "This collaboration is a natural extension of our work and commitment to advancing spine treatment options to patients on a global level."

She added: "Both SpineMark and Wooridul share a fundamental belief that all patients – no matter where they live in the world – should have access to spine care that will improve their quality of life and help them get back on their feet as quickly as possible."

Dr. Jihoon Jeong, director of research and international business at Wooridul, said, "Our goal is to create global medical destination centers that provide advanced treatment options to people who suffer from spinal disorders and diseases. Ongoing research and education activities are at the heart of this goal."

Jeong added, "SpineMark's model of offering physicians and device companies the oversight and support needed to conduct clinical trials under one umbrella will allow us to further our R&D efforts on a global level."

The organizations also plan to develop a medical education center with training facility in Singapore that will be similar to the SpineMark Medical Conference Center at Texas Back Institute in Plano, Texas. This center will serve to train physicians on the latest clinical advancements in spine care.

Medical device companies will be able to contract with SpineMark and Wooridul to gain access to their network of research sites. Once the SpineMark International Medical Advisory Board, which is chaired by Dr. Rudolf Bertagnoli, has approved a prospective study, the SRO will begin enrolling patients under SpineMark CRO Management (SCROM), a wholly owned subsidiary of SpineMark and the nation's only clinical research organization dedicated to the spine.

With this design, SpineMark and Wooridul said they will be able to provide intermediary third-party oversight to clinical trials being conducted in the network to ensure quality monitoring, surveillance and resources are brought to bear for participating patients.

Wooridul Hospital has more than 25 years of experience in providing systematic spine management as a total care system covering spine disease prevention, diagnosis, testing, treatment and rehabilitation. Its 108 spinal surgeons treat patients in its various hospitals located in Seoul, Busan, Gimpo Airport and Daegu.

Best practices document for V.A.C. Therapy

The first comprehensive publication of international best practices for the use of KCI's (Kinetics Concepts; San Antonio) V.A.C. Therapy was introduced at the recent 3rd Congress of the World Union of Wound Healing Societies (WUWHS) in Toronto.

The consensus document, "Principles of Best Practice Vacuum Assisted Closure: Recommendations for Use," was developed by an international expert working group to provide guidance on the successful integration of V.A.C. Therapy into clinical practice for the treatment of six selected wound types.

KCI said the initiative draws on both the significant clinical research evidence and the consensus, best practice opinions of 26 international wound care experts in the group.

"Studies show that Vacuum Assisted Closure (V.A.C.) Therapy has helped to improve wound care outcomes and has led to a number of dramatic changes in clinical practice over the past decade," said Professor Keith Harding, co-chair of the working group and head of the wound-healing research unit at Cardiff University (Cardiff, UK).

He added, "This initiative, which compiles extensive clinical research evidence and the consensus opinion of the world's leading wound-care experts, specifically reviews V.A.C. Therapy's potential use for a number of indications. It offers an easy-to-read, evidence-based reference guide to help physicians provide the best care possible for their patients with complex wounds."

The document outlines recommendations for the use of KCI's V.A.C. Therapy in: diabetic foot ulcers, complex leg ulcers, pressure ulcers, de-hisced sternal wounds, open abdominal wounds, and traumatic wounds. The document also summarizes numerous key studies on the use of V.A.C. Therapy for these types of wounds and considers quality of life and cost-effectiveness, which are important factors when evaluating treatment.

The consensus document will be available in English, German, French, Italian and Spanish on the WUWHS web site at www.wuwhs.org.

Joint venture for cardiac safety services

Cordium Links (Morganton, North Carolina), a provider of centralized cardiac safety monitoring, said that it has established a joint venture with a Chinese organization to deliver core lab services to drug development companies performing cardiac safety evaluation as part of clinical research in China.

The joint venture, called Lawke Links, represents the first effort to bring a full range of ECG core lab services including project management, site support and centralized ECG data analysis to China, according to the U.S. firm.

Lawke Links will provide FDA- and ICH-compliant cardiac safety analysis to biopharmaceutical companies conducting Phase I to Phase IV multinational clinical trials.

In addition to ECG core lab services, Lawke Links has established an exclusive relationship with Peking Union Lawke Biomedical Development (PUL) to provide central lab services.

Jian Ho, MD, PhD, medical director/CEO at PUL, initially will head up project management and site support for Lawke Links in China.