In what is being termed the greatest development in mammography since the technology was invented, a digital mammography system, called the Stenographe 2000D, developed by GE Medical Systems (Waukesha, Wisconsin), won FDA approval in late January. The approval signals a shift from film-based, analog mammograms to digital mammography systems, and essentially launches the science into the computerized, e-health environment.

Among the hospitals quickly adopting the system for use is Northwestern Memorial Hospital (Chicago, Illinois), which participated in the trials leading to FDA approval, with support of $1.8 million in private funding. Those trials required recruiting women who were willing to receive a mammogram with both systems, explained Yolanda Adler, MD, one of the Northwestern researchers. The research team members read both mammograms. "If we disagreed, then a third [team member] was brought in to do another reading, with all of that information then collected," Adler told BBI. Supporting the overall conclusions of the clinical trial data, Adler reported that there is essentially no difference between the analog and digital systems, but that the digital system offers a variety of advantages. These include a reduction in the number of repeat procedures, because of the ability to manipulate the digital image – by changing its contrast or magnifying a particular portion, for instance – and to archive the mammograms electronically or send them to other locations via Internet.

In announcing FDA approval, GE Medical said it had spent 13 years and more than $100 million developing this technology, in the process earning up to 100 patents related to it. Last year, the GE Senographe 2000D was approved for sale in Europe, Canada, Latin America, and much of Asia, and nearly 50 systems already are being used in those areas, GE said.

Initially, digital mammography probably will be used side-by-side with traditional systems, and the path to market maturity is likely to be a fairly long one, according to Philip Drew, PhD, who closely follows the medical imaging sector and writes on the subject for The BBI Newsletter. "It's going to be a very slow path," Drew said. "The economics are terrible." Digital mammography systems will initially be priced in the $500,000 range, compared to "top-end, conventional mammography systems for $80,000 or $90,000, and you can buy perfectly adequate ones for half that," he said. Additionally, he noted that the reimbursement environment for mammography is unlikely to encourage a switch to digital by hospitals and other mammography facilities. "Because it's a very competitive business, and because [mammography] is done quite frequently, the insurers pay minimum dollars for doing mammographic exams," Drew said. Further, he predicted that prices for digital mammography systems would not take the swift downward curve seen in other computer technologies. The biggest factor in pushing prices down is likely to come from other competitors, such as Trex Medical (Danbury, Connecticut) and Fisher Imaging (Denver, Colorado), which also are developing digital systems, Drew said.

Elsewhere in the product pipeline:

Allergan (Irvine, California) has received approval from the FDA to market its Sensar foldable acrylic posterior chamber intraocular lens (IOL), a next-generation acrylic IOL. The Sensar IOL's material and design are intended to minimize unwanted side effects of current acrylic lenses marketed in the U.S. The Sensar is delivered into the eye via the Unfolder Sapphire Series implantation system, a patented device manufactured by Allergan and providing improved control, small incision capability, and a sterile delivery technology. David Pyott, Allergan president and chief executive officer, said the Sensar IOL will complement the firm's other small-incision cataract surgery products, including the Array multifocal IOL, the Sovereign phacoemulsification system, and PhacoFlex II foldable silicone IOLs.

Astro-Med's (West Warwick, Rhode Island) Grass-Telefactor Product Group has introduced the Sonoma systems, a low-cost, compact system for sleep studies. The systems combine modular, high-performance amplifiers with the Gamma software program and a computer-assisted sleep staging system called CAST. The Grass-Telefactor Product Group makes advanced EEG and PSG (sleep monitoring) systems, long-term epilepsy systems and a broad range of products for neurophysiological research.

The CardioVascular Group (Irvine, California) of Baxter Healthcare (Deerfield, Illinois) has launched the AVA 3Xi, which the company calls "the first advanced venous access (AVA) device flexible enough for routine cardiac care and surgeries." AVA 3Xi's design provides flexibility for patients' evolving central venous access requirements in a single device by transitioning from a multi-lumen introducer to a triple lumen device with a detachable introducer valve. The multiple infusion lumens are designed for administration of multiple medications and fluids. AVA 3Xi requires only one insertion site, thus eliminating introducer/triple lumen device change-outs to minimize patient pain and discomfort, and reducing the risk of complications and infection.

The investigational oxygen therapeutic Hemopure (hemoglobin glutamer-250 [bovine]) or HBOC-201, produced by Biopure (Cambridge, Massachusetts) has been shown to eliminate allogeneic red blood cell transfusions in a significant number of patients undergoing vascular surgery, according to clinical trial results recently published in the Journal of Vascular Surgery. Phase II study results showed the product well tolerated in a population consisting largely of elderly patients with complex medical conditions. Results showed that Hemopure totally eliminated the need for red blood cell transfusions in 27% of patients throughout the entire 28-day follow-up period. Moreover, 39% of Hemopure patients required no allogeneic blood during the 96-hour treatment period, and 66% required no allogeneic blood on the day of surgery, further supporting the product's use as an oxygen bridge.

Cogent Pharmaceuticals (West Conshohocken, Pennsylvania) reported successful completion of a two-week Phase I trial evaluating the safety and skin sensitivity of a once-a-day proprietary transdermal patch delivering arecoline, a muscarinic receptor agonist, for treating Alzheimer's disease. The trial included 22 Alzheimer's patients, with comparison to blood level data from another study involving healthy elderly volunteers, demonstrating that the Cogent patch delivered arecoline at levels equal to intravenous doses that in prior published studies demonstrated improvement in cognitive ability. Muscarinic receptor agonists are under development as therapeutic alternatives to acetylcholinesterase inhibitors.

Computerized Thermal Imaging (CTI; Layton, Utah) has rolled out its Breast Cancer System Display software for the first time at Providence Hospital (Washington). David Packer, CTI president, said the demonstration was the first of a series "to gather user comments ... to put the finishing touches on the display software." The software allows the physician to retrieve and manipulate patient images as well as graphically view the results of CTI's proprietary analysis software that helps to indicate whether a breast lump is malignant or benign. Pre-trial testing of the system showed that the technology has the potential to reduce benign biopsies by up to 38% while correctly identifying 96% of the malignant lesions.

Cyberonics (Houston, Texas) has received CE Mark approval to sell the next-generation NCP Generator, the Model 101, in the member countries of the European Union. The company also has received regulatory approval for sale of the Model 101 in Canada. The Model 101 NCP Generator is 22% thinner, 31% lighter and, depending on stimulation parameters, offers up to a 91% longer battery life than its predecessor, the Model 100. Robert (Skip) Cummins, president and CEO, said the Model 101 "is especially important in the international markets, considering that our international approvals are not limited by age. Parents and children living with epilepsy are particularly sensitive to device size and battery life." Cummins added, "In the U.S., the Model 101 has quickly become the generator of choice in the short period of time since its launch on Feb. 1."

Dornier Medical Systems (Kennesaw, Georgia) reported completing patient treatments for the plantar fasciitis component of shockwave therapy clinical trials. Analysis of the data covering 150 patients will support PMA submission to the FDA. The therapy treats plantar fasciitis, tennis and golf elbow, shoulder tendonitis, Achilles tendonitis, patellar tendonitis and pseudarthrosis

Draximage, the radiopharmaceutical subsidiary of Bio-Technology General (Iselin, New Jersey), has begun a Phase III clinical trial of Fibrimage, a diagnostic agent for the detection of deep vein thrombosis (DVT). Fibrimage is a lyophilized (that is, freeze-dried) kit containing FBD labeled with the active ingredient Technetium-99m, prior to use. The product is based on fibrin binding domain (FBD), a recombinant polypeptide with high binding affinity for fibrin, the primary component of DVT. FBD was developed by Bio-Technology General and is licensed to Draximage on an exclusive worldwide basis. Completion of the Phase III trial, involving 130 patients at various centers across Canada, is expected this year.

Imaging Diagnostic Systems (Fort Lauderdale, Florida) said its patent application for the reconstruction algorithms developed for the firm's computed tomography laser mammography breast imaging device has been approved by the U.S. Patent and Trademark Office. The company currently holds two patents for its laser scanning apparatus and another for its fluorescence imaging technique. Together, the three patents cover the key components of its CT Laser mammography system. Imaging Diagnostic is conducting FDA clinical trials at Nassau County Medical Center and the University of Virginia Medical Center for a PMA application filing.

NMT Medical (Boston, Massachusetts) has FDA approval for another indication for its CardioSeal Septal Occluder under the agency's humanitarian use designation regulations, the third such approval received for the device since September 1999. The new approval is for closing patent foramen ovale (PFO) in patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a PFO and who have failed conventional drug therapy. In this most recent approval, the CardioSeal. PFO is a transient hole in the heart that may open under straining efforts (such as coughing or defecating) and has been implicated as a possible cause of embolic strokes.

PharmaSonics (Sunnyvale, California) has introduced its URx intravascular sonotherapy (IST) technology at the EURO-CVS Cardiovascular Summit, which showcased the latest international developments in interventional cardiology and cardiovascular surgery. In live telecasts of two patient cases, the URx IST system was demonstrated to more than 1,300 physicians and other health care professionals attending the conference in The Hague, the Netherlands. IST is designed to prevent in-stent restenosis caused by intimal hyperplasia. PharmaSonics says it is the first company to use sonotherapy, which is therapeutic ultrasound energy delivered via catheter, for this therapeutic application.

QLT PhotoTherapeutics (Vancouver, British Columbia) and CIBA Vision (Atlanta, Georgia) reported that the FDA issued an approvable letter for Visudyne (verteporfin for injection) therapy to treat the wet form of age-related macular degeneration (AMD), the leading cause of adult blindness. The wet form is characterized by the formation of abnormal leaky blood vessels growing across the central part of the retina, called the macula. The Visudyne therapy is a noninvasive, two-step process that targets rapidly growing abnormal blood vessels through the intravenous infusion of verteporfin, a light-sensitizing agent that binds excess lipoproteins produced by the abnormal vessels. Shining a red laser light in the patient's eyes then activates the drug. In November, an FDA advisory panel announced its support for approval of the therapy.

R2 Technology (Los Angeles, California), a developer of neural network technology and developer of the first computer aided detection system for mammography, said that the Japanese Ministry of Health and Welfare has approved its ImageChecker System for use in breast cancer screening in Japan. Last year, R2 Technology and Marubeni America Corp. signed a distribution agreement under which Marubeni will distribute the film-based version of the ImageChecker in that country. Hideyasu Fukuda, vice president and general manager of the electronics and multimedia division of Marubeni, said that with the development of a national mammography program in Japan, "we expect the ImageChecker to play a critical role in early detection of breast cancer."

Somanetics (Troy, Michigan) said that clinical study results demonstrate that the INVOS Cerebral Oximeter is effective in identifying vasospasm during long-term monitoring of sub-arachnoid hemorrhage (SAH) patients in studies. The INVOS Cerebral Oximeter is the only patient monitoring system commercially available in the U.S. that non-invasively and continuously monitors changes in the regional oxygen saturation of the blood in the adult brain. The study evaluated 55 aneurysmal SAH patients monitored continuously with the INVOS and twice daily with transcranial Doppler exams and concluded that the Cerebral Oximeter was effective as a non-invasive, non-operator dependent tool for identifying vasospasm and guiding medical and neuro-interventional therapies. Rocco Armonda, MD, director of cerebrovascular surgery and interventional neuroradiology at Walter Reed Army Medical Center (Bethesda, Maryland), said traditional evaluation of cerebral ischemia in post-aneurysmal subarachnoid hemorrhage patients is expensive, invasive and technically demanding. "The Cerebral Oximeter is a very effective device for identifying early signs of potential ischemia."

St. Jude Medical (St. Paul, Minnesota) reported the first implants of its Genesis system, a new ventricular resynchronization system for the treatment of congestive heart failure (CHF) and suppression of atrial fibrillation (AFib). The Genesis system is comprised of the Frontier 3x2 electrical stimulation device, the Aescula LV Left-Heart Lead and the Alliance Left-Heart Delivery System (LHDS). The Frontier 3x2 device and Aescula LV lead were implanted using the Alliance LHDS in a Class 4 heart failure patient and in a Class 3 heart failure patient Daniel Starks, president and CEO of St. Jude's Cardiac Rhythm Management Division, said the system helps to manage "several complex cardiac conditions that can be significantly worse when they occur together." The Frontier device and Aescula lead provide ventricular resynchronization therapy for the treatment of CHF, and the Frontier also incorporates St. Jude's Dynamic Atrial Overdrive algorithm for the suppression of AFib.

VISX (Santa Clara, California) reported that Japan's Ministry of Health and Welfare approved the firm's STAR S2 Smoothscan Excimer Laser System for the treatment of nearsightedness with astigmatism. Clinical trials to evaluate the safety and efficacy of laser vision correction and the VISX excimer laser system began in Japan in early 1993. VISX says it is the only U.S. company to receive such an approval in Japan. VISX Japan KK, the company's Japanese subsidiary, was established in late 1997 to train, service and market programs to deliver support identical to that available to U.S. physicians.

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