A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) said it has received regulatory and reimbursement approvals from Japan's Ministry of Health, Labor and Welfare for the EnSite system, a computer-based visualization and navigation tool used by physicians when treating patients with irregular heartbeats.

The system allows electrophysiologists to create computer-generated, 3-D models of their patients' cardiac anatomy. After collecting and organizing electrical signal data from the inner surface of the heart, the system shows the location and movement of abnormal electrical impulses, helping physicians determine a treatment strategy. Such enhanced images were not possible with 2-D fluoroscopy.

“The EnSite system is the most advanced computer-based technology for mapping arrhythmias and navigating electrophysiology catheters in real time,” said Kazuo Ogino, president and CEO of Nihon Kohden (Tokyo), St. Jude's EnSite system distributor in Japan.

He said that since market approval, the system has been used at a number of facilities in Japan, including Tsuchiura Kyodo, Yokohama Minato Red Cross, Kumamoto University, Nara Medical University, and the University of the Ryukyus. “This clearly indicates strong clinical utilization by Japanese doctors,” he said.

In the first procedures performed in Japan, electrophysiologists used the EnSite system and the EnSite Array non-contact catheter to diagnose and guide ablation therapy of patients with atypical atrial flutters and atrial fibrillation (AF).

“The introduction of EnSite in Japan will help physicians provide greater clinical value for Japanese patients by accurately diagnosing the origin of arrhythmias quickly and safely,” said Joseph McCullough, president of St. Jude Medical's International Division. “These capabilities are a critical element of effective electrophysiology procedures.”

After heart failure, AF is the most prevalent, debilitating and expensive cardiovascular disease, affecting more than 6 million patients worldwide. It becomes more severe and more common with age.

St. Jude's AF initiatives include products for site access, diagnosis, visualization and ablation therapy.

Rapid tests expanding in Latin America

With the introduction of new players in the competitive landscape and accuracy levels improving, rapid tests are beginning to overcome initial resistance. These emerging players have the ability to potentially increase the addressable market and product awareness, according to Frost & Sullivan.

The global consulting firm finds that providers of rapid tests for infectious diseases in Latin America earned revenues of $28 million in 2005 and estimates them to reach $40 million in 2010.

“The ability of new rapid tests to be dispersed at fractionally low cost across large distances makes it an especially attractive market for the Latin American region,” says Frost & Sullivan Research Analyst Natalia Scomparin.

Expected growth of this market in Latin America is triggered by the kind of geographical and healthcare infrastructure encountered in most of these countries. It is this difficulty in the access to basic infrastructure conditions needed to perform traditional testing, together with higher levels of accuracy that the rapid tests technologies are offering that constitute the two key factors propelling the expected growth of this market.

“Lack of promotion of these techniques together with yet-unexplored potential market users are two avenues to closely consider when targeting growth objectives among this category,” notes Scomparin.

As the market reaches a more mature level of development, new Tier 1 entrants expect to use a combination of price and niche product strategy to reach the higher end of the potential addressable market size in the medium and long term.

1st Niris system shipped to Australia

Imalux (Cleveland) reported that it has shipped its first Niris imaging system to the Australian market via its exclusive distributor, Device Technologies Australia. The company said the milestone is a key achievement in its market development and product introduction activity in that country.

The initial shipment comes on the heels of other market development activity, including image interpretation training for Device Technologies Australia sales and marketing personnel provided by Imalux staff.

The Niris imaging system was presented at the Urological Society of Australasia 's (Edgecliff, Australia) annual scientific meeting in March, the largest and most significant gathering of urology professionals in the Australasia region.

The system is designed to assist physicians in the diagnosis, treatment and monitoring of diseases in multiple specialties, including urology, gastroenterology, gynecology, dermatology, dentistry and ear, nose and throat applications.

Niris is a compact, point-of-care system that creates images using near-infrared light. The system provides clinicians with real-time, high spatial resolution, 2-D, cross-sectional depth visualization of normal and abnormal tissue microstructures. Imalux said the spatial resolution of the system is on the order of 0.01 mm, surpassing conventional ultrasound imaging by an order of magnitude.

Imalux OCT technology has been under evaluation with physicians in a number of specialty areas and has been used with more than 3,000 patients worldwide. The system is FDA-cleared.

IDSI presents at Sao Paulo meeting

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida) displayed CT Laser Mammography (CTLM) clinical cases from international partner sites at the 36th annual meeting of the Sao Paulo Society of Radiology (Sao Paulo, Brazil) as part of its push to commercialize the system in Central and South America.

The company said the cases highlight the capability of its CTLM technology to image angiogenesis, usually associated with breast cancer.

The Sao Paulo exhibition marked the third major South American conference attended in a 10-month period, the company said. IDSI exhibited in a booth with Pyramid Medical Systems, one of Brazil's largest medical device distributors.

The CTLM system is the first breast imaging system that utilizes laser technology and patented algorithms to create 3-D cross-sectional images of the breast. It is a noninvasive, painless examination that does not expose the patient to radiation or require breast compression.