A Medical Device Daily
Medtronic (Minneapolis) reported the launch of its Miracle-ICD Outcome Measured In Japanese Indication (MOMIJI) clinical trial, which it said is the first large-scale, post-market study conducted in Japan by a medical device company.
The MOMIJI trial, a prospective, multi-center study enrolling up to 250 patients at about 25 centers in Japan, will evaluate the effectiveness of cardiac resynchronization therapy-defibrillator (CRT-D) in Japanese patients as compared to patients studied in the MIRACLE-ICD trial. The MIRACLE-ICD trial evaluated the efficacy of CRT-D in heart failure patients in the U.S.
The trial is the result of collaboration between Medtronic Japan and three well-known physicians in Japan — heart failure specialists Shin-ichi Momomura, MD, professor at Jichi Medical University's Omiya Medical Center, and Hiroyuki Tsutsui, MD, professor at Hokkaido University, and electrophysiologist Kaoru Sugi, MD, professor at Toho University Ohashi Medical Center.
The first enrollments were by Momomura and occurred at Omiya Medical.
"I am very excited to be part of this post-market study," said Shin-ichi Momomura, the principal investigator of the trial. "The use of CRT-D therapy in patients worldwide has produced encouraging outcomes, but we want to learn more about its effectiveness in the Japanese patients."
Medtronic says that since 1997 it has supported more than 20 randomized controlled trials evaluating device therapy in more than 8,000 heart failure patients outside of Japan. The company said those trials have confirmed the efficacy of implantable cardioverter-defibrillators (ICDs) and CRT among certain heart failure patients, including the Sudden Cardiac Death in Heart Failure Trial and Cardiac Resynchronization in Heart Failure studies.
This is the first trial that will focus on the effectiveness of CRT-D therapy in a Japan-only cohort, which Medtronic said may help determine if the results of foreign trials apply to the Japanese population.
"Medtronic is committed to bringing the newest and best therapies to improve people's lives in Japan," said Marshall Stanton, MD, VP and general manager of the Cardiac Rhythm Disease Management business for Medtronic in Japan. "The best way to do this is by proving the benefits of therapies through scientific clinical trials."
Eligible devices for this trial include InSync III Marquis CRT-D, which the company said is the No. 1 selling CRT-D device in Japan, and future Medtronic CRT-D devices as they become commercially available.
The InSync III Marquis system combines cardiac resynchronization and defibrillation therapies in a single device for the treatment of moderate to severe heart failure in patients who are at risk for sudden cardiac arrest. The device received reimbursement approval in August 2006 and has been commercially available for six months.
Inverness to acquire distributor in India
Inverness Medical Innovations (IMI; Waltham, Massachusetts) has entered into an agreement to acquire Spectral Diagnostics Private (New Delhi, India), a private distributor of professional diagnostics products, and its affiliate, Source Diagnostics (Shimla, India) an assembly and packaging operation.
The deal calls for an initial payment of $4 million in cash and Inverness stock, with an additional payment to be made one year from the closing if certain post-close revenue and profitability targets are achieved.
The transaction is expected to close in about 60 days, upon receipt of certain regulatory approvals.
IMI said that the acquisition of Spectral and Source will provide it with an established distribution network and packaging operation in India for its professional diagnostic products.
The company said India represents one of the biggest opportunities for rapid testing for blood-borne pathogens such as HIV, hepatitis, malaria and Dengue fever. In addition, it is estimated that 4.5 million people in India have tuberculosis, with 1.8 million new cases every year.
Ron Zwanziger, CEO and chairman of IMI, called the acquisition "an exciting step toward establishing direct sales into the growing Indian market."
Sulekha Chawla, president of Spectral and Source, said, "The combination of Inverness' product line and research capabilities with Spectral's growing distribution capabilities in India is an excellent match. We believe that the opportunities created by this acquisition are enormous."
IMI develops advanced diagnostic devices and says it is exploring opportunities for its electrochemical and other technologies in a variety of professional diagnostic and consumer-oriented applications.
Kenyan company orders OTI MediSmart cards
On Track Innovations (OTI; Fort Lee, New Jersey), a provider of contactless microprocessor-based smart card solutions for homeland security, payments, petroleum payments and other applications, said that Smart Applications International, a Kenyan company focused on delivering secure healthcare solutions, has placed an order for 100,000 MediSmart cards, to be issued by multiple medical plan managers.
Smart has commissioned close to 200 points of service at hospitals, pharmacies and general practitioner sites across Kenya, enabling patient authentication, verification of benefits and claims processing in a seamless process. Contactless smart cards have already been issued by a number of medical program managers as part of the program.
With OTI's MediSmart, the Kenyan company is providing a complete healthcare solution, including cards, readers and related software seamlessly integrated with hospital management systems, where up to 75% of patients in Kenya, receive their primary healthcare services. In addition to the hardware revenues, OTI receives a monthly license fee per issued card.
On Track Innovations said the MediSmart solution offers secure and fast front-end patient authentication and benefit verification at the service provider level, allows for electronic clinical data capture and electronic claim and/or report generation, within benefit rules in respect of services provided and benefit utilization by members and their dependents, and simultaneously switches such relevant data to the corporate and insurer levels while also recording it on each patient's own mobile data repository.
"MediSmart has provided a sure way of eliminating medical scheme abuse. A unique feature of the solution, enabled by OTI's technology platform, supports the management of shared family benefits, eliminating a major financial risk to medical schemes," said Pauline Muriuki, managing director of the Kenyan company.