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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.”

St. Jude also said it received European CE-mark approval of its newest devices for treating patients with potentially lethal heart arrhythmias and heart failure. The Epic II ICD (implantable cardioverter defibrillator) and the Epic II HF CRT-D (cardiac resynchronization therapy defibrillator) feature faster device data transmission to speed patient follow-up exams and a “patient notifier” that gently vibrates to alert patients of critical changes in device function, the company said.

The first European implant of the Epic II VR was performed by Johannes Holzmeister, MD, and Firat Duru, MD, professor and director of pacing and electrophysiology at University Hospital (Zurich, Swit-zerland).

“Telemetry in the new Epic II ICD is noticeably faster, particularly when downloading stored electrograms,” said Duru. “The device also includes the first vibration-based patient notifier. Unlike other products on the market that use an audible notifier, the Epic II device may be particularly helpful for patients who have trouble hearing.”

St. Jude said the Epic II devices, which received FDA approval last month, include:

• Faster telemetry, designed to speed data from the ICD to the system programmer at a rate up to five times faster than previous St. Jude Medical devices.
• The industry’s first non-audio alert, which vibrates to notify patients of critical changes in device performance so they can contact their clinician for follow-up care.
• SenseAbility technology, a St. Jude technology designed to protect against inappropriate ICD shocks.
• AutoIntrinsic Conduction Search, intended to promote more natural heart function and minimize ventricular pacing. Studies have shown that excessive ventricular pacing may contribute to heart failure in some patients.
• DeFT Response technology designed to help physicians manage patients who require higher levels of defibrillation.

“The Epic II devices offer important benefits to patients and their physicians, including an innovative patient notification feature, advanced diagnostics and the ability to conduct faster follow-up exams,” said Eric Fain, MD, executive vice president of development and clinical/regulatory affairs for St. Jude’s Cardiac Rhythm Management Division. “These devices, along with the recently launched Merlin Patient Care System, provide state-of-the-art technology to European physicians as they manage the complexities of heart failure.”

St. Jude also reported CE-mark approval for two new electrophysiology (EP) products – the Therapy Cool Path all-braided ablation catheter and the IBI-1400-CV Internal Cardioversion system.

The announcement was made at Cardiostim 2006, a biannual meeting of cardiac specialists held in mid-June in Nice, France.

St. Jude Medical presented results from its QuickOpt Optimization clinical study at Cardiostim’s late-breaking clinical trials session and sponsored several symposia during the international congress.

The Therapy Cool Path all-braided ablation catheter delivers radio frequency energy to specific cardiac tissue, creating lesions that interrupt the abnormal electrical signals that contribute to heart arrhythmias. The catheter’s tip cools tissue as energy is applied, helping physicians create deeper, more effective lesions. Its all-braided shaft gives physicians more control and precision in maneuvering and placing the catheter.

The IBI-1400-CV Internal Cardioversion system helps physicians provide cardioversion (restoring a patient’s normal heart rhythm) – via catheter – quickly and simply during EP procedures with lower voltage than is necessary for successful external cardioversion, St. Jude said. Physicians can flip a switch to change the catheter from a diagnostic tool to providing cardioversion.

Lumenis gets Chinese approval

Lumenis (Yokneam, Israel), a global manufacturer of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, said it has received approval from China’s medical device regulating authority to sell its Selecta II system in that country.

SLT works by using a specific wavelength to irradiate and target only the melanin-containing cells in the trabecular meshwork. Because of the specific wavelength of light generated, as well as the power and duration of the exposure, SLT selectively targets pigmented cells in the trabecular meshwork and causes no discernable damage to adjacent tissue.

The company said experts postulate that the single largest ethnicity with glaucoma will be Chinese by the year 2010. Worldwide, there will be more than 60 million people with glaucoma, which will continue to be the second-leading cause of preventable blindness. Patients with the disease will continue to increase to nearly 80 million by 2020.

Lumenis said that currently, 80% of the visually impaired in China live in rural areas, while 70% of the country’s 24,000 ophthalmologists work in urban hospitals, making glaucoma drug compliance monitoring “extraordinarily difficult.”

“With Lumenis’ Selecta II Selective Laser Trabeculoplasty (SLT) technology, doctors in China will now be able to treat their glaucoma patients with ‘a drop of light’ – and secure 100% therapeutic compliance,” the company said.

Avner Raz, president and CEO, said, “While the use of SLT has increased rapidly since Lumens’ family of Selecta laser systems gained FDA clearance, we continue to identify and pursue untapped markets for our technologies. Our entrance into China with the Selecta II and SLT signifies a major milestone in this effort.”

Dr. Ding Lin, MD, PhD, director of Aier Eye Hospital Group (Changsha, China), one of that country’s largest private hospitals, said, “The problem of glaucoma in China is a staggering one. As a clinician treating glaucoma, I can say the challenge of patient compliance to a pharmaceutical treatment paradigm is complex. In China, as in many other countries, patient compliance to these drops is dismal. We welcome SLT as part of the glaucoma management tools.”

Lumenis said researchers have found treated and untreated tissue to be nearly indistinguishable. When treated with SLT, a primarily biologic response is induced in the trabecular meshwork which involves the release of cytokines that trigger macrophage recruitment and other changes, leading to a reduction in intraocular pressure (IOP).

The company said that since its introduction in 2001, Selecta II has demonstrated to clinicians the ability to reduce IOP associated with glaucoma – vs. the need for ongoing and repeated medication for therapy – and directly addresses patient compliance concerns.

Cardiac marker market on growth curve in Europe

The market for cardiac markers used in primary care is experiencing a tremendous rate of growth across Europe due to their precise diagnostic properties. With rapid turn-around times, these cardiac markers are seen enabling cost reductions and improved patient outcomes.

International consulting firm Frost & Sullivan says that over the next three to four years, cardiac markers will be implemented more effectively in primary care to support decreased bed occupancy, hospital costs and physician time.

Frost & Sullivan said that the European primary care cardiac diagnostics market had revenues of $50.3 million in 2005 and estimates this to reach $149.4 million in 2012.

“Cardiac point-of-care testing (POCT) offers many benefits for primary care, particularly in improving turnaround results and in allowing earlier and more appropriate treatment,” said Dr. Fiona Rahman, Frost & Sullivan team leader of clinical diagnostics.

She added: “POCT can better satisfy customer needs with the introduction of new cardiac markers; in addition to boosting patient confidence with on-the-spot tests that improve disease diagnosis and monitoring, these diagnostics also enable the implementation of programs designed to prevent the onset of diseases.”

Cardiologists have developed the market by switching from conventional methods of heart disease diagnosis to these markers. The use of cardiac diagnostic tests in primary care is poised to grow due to the introduction of point-of-care technologies.

“These cardiac markers will give more valuable indications during emergencies towards determining appropriate treatments and the level of risk of a heart attack,” said Rahman. “The rapid turnaround times of cardiac markers will reduce costs and improve the treatment of patients admitted with chest pain.”

She said that although the science behind cardiac assessment is growing, the cardiology community still requires further education and training on the advantages of these risk markers. Rahman said medical communities in the UK and France in particular are hesitant to adopt new methods of diagnosing, treating and managing patients without adequate corroboration that they will make significantly enhanced contributions to patient well-being and cost savings.

“Physicians are sceptical about adopting novel markers and continue to rely on tried and tested methods of diagnosis, which are cheaper and do not require validation and scientific support,” she said. “These end users are reluctant to experiment with expensive markers, which are essential to complement more traditional diagnostic methods.”

In its report, “European Utilization of Cardiac Markers in Primary Care,” Frost & Sullivan said the challenge for manufacturers will be to promote cost-effective cardiac diagnostics markers as well as to encourage end users to trial and adopt risk tests as routine diagnosis.

Ultimately, the report said, increasing awareness about the benefits of using cardiac markers in primary care will benefit both healthcare providers and patients. Informed patients who understand the concept of cardiac markers are more likely to request the most current and novel markers available.

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.

Company granted license for prion assays

Genesis Bioventures (GBI; New York) said it has granted an exclusive license to Bio Business Development Co. (BBDC) to commercialize the Rapid Prion Detection Assays in 18 Pacific Rim countries. The licensed technology has been developed by Prion Developmental Laboratories (PDL), a portfolio company of GBI.

GBI has the exclusive, worldwide sales, marketing and distribution rights to commercialize the recently patented Rapid Prion Detection Assays, including rapid tests for bovine spongiform encephalopathy (BSE, or “mad cow” disease) in cattle and scrapie in sheep. With the agreement, BBDC, a Canadian business development company, becomes GBI’s marketing, sales and distribution partner in the Pacific Rim to launch sales of the assays.

Our commercialization strategy is focused on global partnering, which we believe will get us to market quickly at substantially lower costs,” said Douglas Lane, CEO and president of Genesis Bioventures. “Our initial target markets for PDL’s BSE Rapid Assay are in the Pacific Rim. BBDC has extensive contacts in Australia, New Zealand, China, and Japan, which has stringent procedures that require all animals used for food production to be tested for BSE.”

He added: “Our patented Rapid Prion-Detection Assay is designed to test for prion diseases, such as mad cow disease, directly at the point-of-kill rather than in a laboratory. The Assay is an easy-to-use rapid strip test that can be administered by trained individuals at slaughterhouses with visual results produced in less than an hour.”

PDL recently achieved 100% sensitivity and 100% specificity in a trial on confirmed positive and negative samples at the Veterinary Laboratory Agency in Weybridge, UK.

The company produces tests for transmissible spongiform encephalopathies such as BSE in cattle, scrapie in sheep and goats, and chronic wasting disease in deer. Formed in 2001, PDL has developed a number of rapid tests that are manufactured on-site.

Cynosure system approved in S. Korea

Cynosure (Westford, Massachusetts), manufacturer of an array of light-based aesthetic treatment systems, reported receiving premarket approval from the Korea Food and Drug Administration for its Cynergy vascular laser system with MultiPlex technology.

CEO Michael Davin said the approval to sell the system in South Korea represents the company’s second major product introduction in that country this year.

“The Cynergy workstation with MultiPlex technology marks an innovative development in the treatment of dermatological vascular conditions through the use of laser-based technology,” he said.

Cynosure said the Cynergy workstation with MultiPlex technology is the first system to enable the rapid sequential emission of two wavelengths from the same fiber optic – a pulse-dye laser and an Nd:YAG laser – with a short time delay between the two pulses. It said the time delay increases the safety and efficacy of laser treatment.

In clinical studies, treatments using the Cynergy workstation with MultiPlex technology have shown an increased depth of penetration of energy and improved effectiveness in treating “port wine” stains and improved outcomes for facial and leg telangiectasia when compared to treatments using a pulse-dye laser or an Nd:YAG laser individually.

According to the company, the limited efficacy of either a pulse-dye laser or an Nd:YAG laser in the treatment of port wine stains, hemangiomas and spider veins made those conditions resistant to treatment. It said its MultiPlex technology “allows for customized, patient-specific treatments using these two lasers together, which improves efficacy, decreases treatment lengths and shortens patient downtime.”

Cynosure’s Cynergy workstation with MultiPlex is distributed in South Korea by OrientMG (Seoul, South Korea). “As the only dual-wavelength, single fiber optic system available in the Asia Pacific marketplace, the Cynergy workstation with MultiPlex technology provides a distinct competitive advantage for our customers,” said Douglas Kim, president of OrientMG. “This technology enables our customers to offer a broader array of treatment options for vascular lesions, hair removal and skin rejuvenation.”

U.S. firm gets 1st CE marks

Regeneration Technologies (RTI; Alachua, Florida), a processor of orthopedic, cardiovascular and other biologic implants, said it has received its first CE marks for several Sterling implants used in spinal, sports medicine and general orthopedic surgeries. The xenograft implants can now be distributed throughout Europe.

The implants receiving the CE mark include Sterling Cancellous Chips, Sterling Cancellous Cubes, Sterling Suture Anchor, Sterling Interference Screw ST, Sterling Interference Screw HT, Sterling Impacted Cortical Wedge, Sterling Impacted Cortical Ring, Sterling SR, Sterling Machined Dowel and the Sterling HTO Wedge.

The Sterling Biological Matrix provides surgeons an expanded supply of safe, sterile tissue that is a natural alternative to autograft, allograft and synthetic resorbable materials. The company said studies show that Sterling grafts maintain structural integrity and biocompatibility.

RTI said the addition of Sterling implants to its international distribution allows it to further tap into a $369.5 million international biologics market. The Sterling implants with the CE mark are available through the company’s international distribution partners.

“Our plans to launch and grow our Sterling product line are advanced by these certifications,” said Brian Hutchison, RTI’s chairman, president and CEO. “We can now bring sterilized xenograft to surgeons internationally, supplementing the unmet demand for biological solutions in surgery.” He added: “It is RTI’s goal to lead the biologics evolution in healthcare, and we remain committed to enhancing the lives of patients by pioneering health solutions through regenerative medicine.”

To receive the certifications, the Sterling implants were first assessed under the European Medical Device Directive 93/42/EEC Annex II Section 4. They also were required to satisfy Transmissible Spongiform Encephalopathies Directive 2003/32/EC, a more stringent standard that requires both proof of product safety and demonstration of a clinical need for the product.

RTI said it was able to prove the safety of the Sterling bovine line through its longstanding, exclusive agreement with a U.S. Department of Agriculture-certified, bovine spongiform encephalopathy-free closed and organic herd. The Sterling implants also offer the benefits of RTI’s BioCleanse Tissue Sterilization Process, which enables delivery of sterile xenograft implants with improved biocompatibility and preserved structural integrity.

Cholestech wins Mexican contract

Cholestech (Hayward, California) and Nutritional Science and Technology (NST; Mexico City), Cholestech’s Mexican partner, have entered a contract with the Mexican Ministry of Communication and Transportation to supply the Cholestech LDX System, a cholesterol monitoring tool, for the Direccion General de Proteccion y Medicina Preventiva en el Transporte (DGPMPT).

As part of the agreement, the DGPMPT will initially acquire 42 LDX Systems and 25,000 lipid test cassettes that will be used in the national health and wellness initiative targeting commercial vehicle operators. DGPMT regulates the safe movement of materials and people throughout Mexico, including the licensing of operators of taxis, buses, airplanes, railroad, ships and tractor trailers. Every year, more than 100,000 transportation workers must complete physical examinations to ensure that their health complies with the ministry’s standards for job qualification.