A second player has officially arrived in the potentially lucrative drug-eluting stent market with a European approval, though no company has yet to achieve a coveted U.S. approval. Joining Johnson & Johnson's (J&J; New Brunswick, New Jersey) Cordis (Miami Lakes, Florida) unit in the still-elite club in late January was Boston Scientific (BSX; Natick, Massachusetts), which said it received the CE mark for its Taxus paclitaxel-eluting stent system. The Taxus product, will use Boston Sci's Express2 coronary stent system launched in the U.S. last September as its platform, and the company said it plans to launch the system this month in Europe and other international markets, and has set its sights on the ultimate prize, a late-2003 launch in the U.S.

While BSX is ambitious, it still will be the second company to cross the U.S. approval finish line, giving J&J an expected several months of exclusive sales in the larger market, estimated to be worth between $2 billion and $3 billion annually. Cordis received its CE mark for the Cypher sirolimus-eluting stent last April, and the stent garnered a recommendation for approval from the FDA's Circulatory System Devices panel in late October. While conditions placed on the Cypher by the FDA panel, particularly a request for a small pharmacokinetic study, could slow down J&J's drive toward final clearance, the company still is expected to get the approval no later than March or April, giving it at least one fiscal quarter of U.S. sales exclusivity.

For its part, Boston Scientific is plenty excited about its entrance into the market. "This is an historic day for our company and for the treatment of coronary artery disease," said Jim Tobin, president and CEO. He added that the company was "further encouraged" by recent data that demonstrates a "beneficial edge effect, improvements in diabetic patients, and the absence of systemic levels of paclitaxel."

William Hunter, MD, president and CEO of Angiotech Pharmaceuticals (Vancouver, British Columbia), which co-licenses paclitaxel to Boston Scientific, said, "the European approval and commercial launch of the Taxus coronary stent is the most significant achievement and milestone event in our company's history." He added, "Our partner, Boston Scientific, has built a solid reputation in interventional cardiology by building superior products. The paclitaxel-eluting Taxus stent will be an important addition to that legacy."

Boston Sci beat out competitor Guidant (Indianapolis, Indiana) for second place in the drug-eluting stent sector, but not without a fight. A U.S. judge shot down that company's end-around foray into the sector after BSX contested the validity of a licensing agreement for use of the drug paclitaxel manufactured by Angiotech used to coat both companies' stents. Guidant had partnered with privately held Cook (Bloomington, Indiana) on a stent system called the Achieve. The Achieve system used Cook's paclitaxel drug coating and manufacturing processes and its portion of the licensing agreement with Angiotech and incorporated Multi-Link Penta Stent System components supplied by Guidant. The Achieve actually received the CE mark last September, but launch of the product was held up pending the outcome of the licensing dispute. When Guidant's efforts to circumvent the paclitaxel issue by buying Cook failed in the courts in December, the company scrapped its plans for the merger and any claims to use of paclitaxel. It still is not clear whether the Achieve can be marketed by Cook or if that company even has the marketing power to go it alone with such a launch.

In a webcast with market analysts at the time of the CE mark approval, Boston Scientific expressed optimism about its future growth potential, noting that its income for 4Q02 soared more than 62% amid what it termed "brisk U.S. sales" of the newly launched Express coronary stent. The company said that Express sales, coupled with the European approval of the Taxus system, spell "unprecedented market opportunities" for it in 2003 and 2004. BSX noted that it and J&J are expected to be the only companies offering coated stents which will be around triple the price of a bare-metal stent until 2005.

While Boston Scientific is still in second place in the drug-eluting stent market, it is hoping that its newer technology platform will ultimately win the day. "We won't be first, but we will be best," Tobin said in a media interview last month. He said his company has the advantage of having a drug-coated stent that uses new stent technology, compared with J&J's stent, which is about three years old. He said his company has been beefing up its European sales force in advance of its launch of the Taxus stent this month.

The company also said it would present its Taxus IV coated stent data to be used for an FDA submission at the Transcatheter Cardiovascular Therapeutics conference in Washington in September. The data on 1,326 U.S. patients will show how the stents performed after nine months.

Elsewhere in the product pipeline:

American Bio Medica (ABMC; Kinderhook, New York) reported the launch by Hema Diagnostic Systems (Miami Beach, Florida) of the Rapid-1-2-3 platform technology, an immunochromatographic testing system for infectious diseases, as a major breakthrough in the testing efforts of both companies. The initial product in the Rapid 1-2-3 series is the Rapid 1-2-3 Hema HIV test, developed by Hema Diagnostic Systems in cooperation with ABMC. The assay integrates Hema Diagnostics' housing design with ABMC's membrane test strips. The on-site test detects antibodies to the HIV-1 and HIV-2 viruses, requiring only a few drops of whole blood. It delivers results in 15 minutes. Hema Diagnostics introduced the test at the MEDICA 2002 conference in Dusseldorf, Germany. The Rapid 1-2-3 Hema HIV test is available in international markets and for research use only in the U.S. An FDA 510(k) submission is expected in 2Q03.

Biotronik (Lake Oswego, Oregon) reported the commercial release of the Belos DR-T, which it said is the world's first dual-chamber, rate-responsive implantable cardioverter defibrillator (ICD) that is designed to instantly and automatically notify a physician when a patient has received life-saving therapy without any involvement from the patient. The company said the new ICD reflects the company's commitment to innovative technology that helps improve patient outcomes while simplifying routines for healthcare providers. The Belos dual-chamber family received market approval from the FDA on Dec. 20. The DR-T is the flagship device of the company's Belos family of ICDs, which also includes the VR-T, DR and VR models. Belos dual-chamber ICDs use SMART Detection and Redetection, which are designed to be the most accurate and reliable AV discrimination features available to distinguish life-threatening arrhythmias from normal heart rhythms. Appropriate discrimination is vital because inaccurate detections may result in the delivery of unnecessary therapy that can be painful and stressful for patients, the company said.

Cardima (Fremont, California) said the Therapeutic Products Directorate of Health Canada has approved a license to market the company's Revelation family of ablation microcatheters for the treatment of atrial fibrillation (AF). The license covers the Revelation Tx, Revelation T-Flex and Revelation Helix.

CardioTech International (Woburn, Massachusetts) reported receiving FDA 510(k) clearance of an antibiotic hydrogel wound and burn dressing. The antibiotic hydrogel dressing is indicated for venous stasis ulcers, diabetic ulcers, pressure sores, blisters, superficial wounds, abrasions, lacerations and donor sites. The clear dressing is manufactured from CardioTech's hydrophilic polyurethane, specifically designed to absorb exudate and provide protection to the wound without the need to remove the dressing for inspection.

CryoVascular Systems' (Los Gatos, California) PolarCath System, which uses a new form of angioplasty to open blocked arteries by cooling and dilating them, appears to be more successful and result in fewer complications than conventional balloon angioplasty. Early multicenter results using the PolarCath Peripheral Transluminal Angioplasty System to treat blocked leg arteries were presented at last month's International Symposium on Endovascular Therapy meeting in Miami Beach, Florida. At nine months, 85% of the treated lesions remained patent, which is significantly better than expected patency rates for either angioplasty or stenting. The company said PolarCath has a balloon system that is advanced to the site of the blockage and filled with liquid nitrous oxide, which evaporates into a gas upon entering the balloon. The evaporation process cools the balloon to specific sub-freezing temperatures, thereby cooling the plaque and vessel wall as it dilates the vessel. This is believed to crack the plaque and aid in reshaping it with minimal injury to the vessel wall, and consequently with minimal inflammation. In traditional angioplasty, the balloon is filled with saline and the walls of the clogged artery are compressed, causing injury in the vessel that triggers an inflammatory response. This inflammation in turn causes a reclogging of the artery or restenosis, CryoVascular said. An estimated 40% or more of femoropopliteal angioplasties (angioplasty in the legs) result in restenosis within nine months to one year. The PolarCath Peripheral Transluminal Angioplasty System is approved by the FDA and will be commercially available in the U.S. this year. The device has been available in Europe since last year.

Eko Systems (Fairfax, Virginia) and Criticare Systems (Milwaukee, Wisconsin) reported a new product line consisting of Criticare's line of physiological monitors and Eko's JEM technology called DataCap. DataCap is a Windows application that takes patient physiological parameters from Criticare Systems monitors and sends the data to other personal computers via Health Level 7 or as text files. The JEM directly communicates to the DataCap software as it is connected to the serial port on a Criticare monitor and connected to the hospital network. The JEM is a key piece of Eko Systems' integrated clinical information management systems solution called Frontiers. It is a small (6" x 2" x 1.25") device that is completely self-contained, has a serial port input, one ethernet connection and small display. The JEM was designed as a universal solution to capture the serial output from patient monitoring and other medical devices within the hospital environment.

Endologix (Irvine, California) reported that the Journal of Vascular Surgery published the results on the first 118 patients enrolled in its pivotal trial for its PowerLink System in the treatment of abdominal aortic aneurysms. The findings were detailed in a manuscript titled "Clinical Research Studies from the Eastern Vascular Society Multicenter Trial of the PowerLink Bifurcated System for Endovascular Aortic Aneurysm Repair" in the December issue. The investigators reported that the PowerLink was safely deployed in 115 of the 118 patients (97.5%), with no device-related deaths during the perioperative period. They reported a 30-day endoleak rate of less than 6% and that the low endoleak rate appears to be superior to that reported by other devices. The patients were monitored for up to 25 months with a mean follow-up period of 16 months for the entire cohort, during which there were no aneurysm ruptures, wire fractures or material failures. There was only one incidence of late device migration (0.8%), deemed to be clinically insignificant.

An FDA panel last month recommended approval for a permanently implanted device to treat acid reflux, though with a long list of conditions. The Gastroenterology and Urology Devices advisory panel ultimately recommended unanimous approval for Enteryx, a device developed by Enteric Medical Technologies (Foster City, California), which was acquired by Boston Scientific (Natick, Massachusetts) in May 2002. Enteryx is a liquid solution injected into the lower esophageal region. The liquid then solidifies into a sponge-like material to reinforce the sphincter that is supposed to prevent stomach acid from getting into the esophagus. The device's specific indication is for the treatment of gastroesophageal reflux disease (GERD), a condition afflicting millions of Americans. GERD contributes to the sphincter becoming relaxed, and the acid that flows into the esophagus causes heartburn and can damage the esophageal lining as well. Prescription drug sales for treating the disease amounted to $8.3 billion in sales in 2000, according to the company. Panelists voiced their concern that the 19 patients involved in the clinical trial were followed for one year only, and that long-term effects of the device were not known. Alan Stein, president and chairman of Enteric Medical, told the panel that the company would conduct three years of post-market surveillance on the patients. One panelist suggested going to four years. Enteryx could serve as an alternative to patients who choose not to undergo anti-reflux surgery, as well as those who don't want to rely on proton pump inhibitors indefinitely, Stein told members of the panel during the company's presentation. Implanting the device takes less than an hour, and physicians use endoscopic tubes to inject the solution, he added. During the clinical trial, 70% of patients were able to completely eliminate the use of proton pump inhibitors up to 12 months following the implant. Further, 10% of patients were able to reduce the use of medicines by half, Stein said.

Ethicon Products (Somerville, New Jersey), a division of Ethicon, a Johnson & Johnson (New Brunswick, New Jersey) company, has received FDA clearance to market its Vicryl Plus Antibacterial Suture. The company said the Vicryl Plus is the first and only suture designed with an antibacterial agent to reduce bacterial colonization on the suture. It said the agent is known to be effective against staphylococcus aureus, staphylococcus epidermidis and methicillin-resistant strains of staphylococcus, the leading surgical site bacteria.

ev3 (Plymouth, Minnesota), a privately held endovascular company, said the Protege GPS stent is the latest version of the Protege self-expanding stent line ev3 obtained with its acquisition of IntraTherapeutics in November 2002. The Protege GPS self-expanding stent is a laser cut, nitinol stent that features tantalum markers on the stent ends to increase radiopacity and assist in visualization for accuracy of stent placement. ev3 said the Protege GPS stent has gained clearance for use in the biliary system. The original version of the Protege stent also is under study to determine its safety and effectiveness in treating patients with peripheral vascular disease of the iliac artery. The company said the Protege GPS stent is accurate to place because it does not shorten at any expanded diameter range. The stent also features the EX.P.R.T. placement technology, designed to eliminate any stent jumping by anchoring the proximal stent tips to a securement ring. And, said ev3, the StarPort technology offers the ability to inject contrast media through the body of the catheter allowing visualization prior to stent placement.

Given Imaging (Norcross, Georgia) said the Centers for Medicare & Medicaid Services (CMS) has established a code and payment rate for capsule endoscopy for the Medicare Physician Fee Schedule. The decision came just 16 months after the M2A capsule endoscope received FDA clearance in August 2001 and should expand use of capsule endoscopy by gastroenterologists treating Medicare patients, the company said.

Guidant (Indianapolis, Indiana), continued its recent rapid pace of approvals in the congestive heart failure (CHF) arena with the mid-January FDA clearance of the Contak Renewal cardiac resynchronization therapy defibrillator (CRT-D). The company said full commercial launch of the advanced heart failure therapy system began immediately. The device will compete with Medtronic's (Minneapolis, Minnesota) InSync ICD system, which gained FDA approval last June. The implantable Renewal device combines a pacemaker to help regulate a patient's heartbeat with a defibrillator aimed at resuscitating patients with dangerously fast heart rhythms. It is the third CRT-D device from Guidant that U.S. regulators have approved in the past year. The company received formal approval of its Contak CD/EasyTrak system in May. The next generation of that device, the Contak CD 2, received FDA approval in October, with Guidant saying at the time that it was the second in a "deep pipeline" of cardiac resynchronization therapy defibrillators. According to the company, the Renewal is the first system designed specifically for patients and physicians struggling with heart failure. The system contains new diagnostic capabilities that are designed to help physicians better manage their patients' conditions. The Renewal provides both cardiac resynchronization therapy and implantable defibrillator therapy, to address both of the principal mechanisms by which heart failure patients die pump failure and sudden cardiac death. Included in the array of new diagnostics and therapeutic features in the Renewal CRT-D is the incorporation of a left ventricular protection period, a feature specifically designed to prevent potentially pro-arrhythmic left ventricular pacing, which may occur without adequate left-side sensing. The Renewal also introduces two new heart failure-specific diagnostic features. The first monitors heart rate variability (HRV); the second, called Activity Log, uses data from a motion sensor to track trends in the patient's activity. The HRV diagnostic tool is the first of its kind to be incorporated into a CHF device, the company said.

A bandage manufactured by HemCon (Portland, Oregon) and intended for both civilian and military use has been approved by the FDA. Its initial customers will be U.S. soldiers. Made from chitosan, a shrimp-based product, the bandage was invented at the Oregon Medical Laser Center, based at Providence St. Vincent Medical Center (also Portland), through a research grant from the U.S. Army Medical Research and Materiel Command.

I-Flow (Lake Forest, California) reported the launch of the ON-Q Elite Pain Relief System, an extension of its ON-Q Post-Operative Pain Relief product line. ON-Q Elite was specifically designed to meet the need for a simple, reusable pump that provides post-operative pain relief for surgeries performed in outpatient surgery centers, the company said. ON-Q Elite can utilize existing reimbursement codes where pain management is a covered benefit requiring the use of durable medical equipment. I-Flow said the infusion pump will be marketed through its InfuSystem operating unit. The ON-Q Elite Pain Relief System is designed to infuse a local anesthetic directly to a surgical site over multiple days following a variety of surgeries, including orthopedic procedures and hernia repair.

Li-Cor Biosciences (Lincoln, Nebraska) has introduced the In-Cell Western, an assay for analyzing signal transduction pathways that, it said, "offers a 30-fold throughput increase compared to traditional Western blots." In-Cell Westerns were developed for Li-Cor's Odyssey Infrared Imaging System and are used to quantify proteins directly in the cell and provide simultaneous detection of two protein targets, avoiding artifacts caused by working with cell lysates. In-Cell Westerns are performed on fixed cultured cells in 96- and 384-well microplates and so bypass the gels and cell lysates required for Western blotting. Additionally, Odyssey features two-color detection to simultaneously quantify two targets, thus increasing accuracy by providing data normalization. The assay is useful for quantitative assessment of phosphorylation with phospho-antibodies, and was designed to facilitate screening of drug candidates for effects on phosphorylation, Li-Cor said.

Medtronic (Minneapolis, Minnesota) launched the Xpedient Delivery System for its AneuRx AAA Stent Graft System, which repairs abdominal aortic aneurysms through a minimally invasive endovascular repair procedure. The AneuRx stent graft with the Xpedient Delivery System, now available in the U.S., will make deployment easier for physicians, while facilitating delivery through tortuous vasculature. Medtronic AVE, the company's Vascular Division, is headquartered in Santa Rosa, California. Indicated for the treatment of abdominal aortic aneurysms, the AneuRx system has emerged as the minimally invasive system of choice for those physicians whose patients, because they are elderly, frail or suffer from multiple illnesses, are considered high-risk candidates for surgical repair of their aneurysms, the company said.

Medtronic Physio-Control (Redmond, Washington) has introduced what it calls its "most rugged automated external defibrillator (AED)," the Lifepak 500 DPS, designed for medical emergencies in difficult and dangerous settings. The Lifepak 500 DPS AED, it said, was tested to military specifications to operate at higher altitudes and withstand shock, vibration, dust, fog and salt, and "is ideal for use in outdoor and mobile settings, such as law enforcement, public safety, utility work, underground mining operations, on helicopters, at the scene of a natural disaster or for search and rescue operations." It was tested to operate at altitudes from minus 2,000 feet to 15,000 feet and to withstand higher levels of shock and vibration. The Lifepak 500 DPS also is compatible with Lifepak defibrillator/monitors, used by 80% of the emergency medical services, according to the company. Medtronic Physio-Control, a unit of Medtronic, reports more than 350,000 Lifepak devices distributed worldwide.

Metrika (Sunnyvale, California) has received FDA clearance to make its A1cNow diabetes monitor available to patients over the counter. A1cNow is the only diabetes test for use at home to obtain immediate glycated hemoglobin (HbA1c or A1C) results, a gold-standard indicator of diabetes control and risk of complications. The disposable, pager-sized A1cNow Monitor provides quantitative A1C results in just eight minutes from a small drop of blood. A1cNow is certified by the National Glycohemoglobin Standardization Program (NGSP) and waived under the Clinical Laboratory Improvement Amendments (CLIA) a regulatory status reserved for those diagnostic technologies deemed so simple to use that the likelihood of an erroneous result is negligible. A recent survey by the American Association of Diabetes Educators (Chicago, Illinois) found that 75% of people with Type 2 diabetes do not know their A1C number. Studies have shown that A1C testing, previously performed only in a hospital laboratory or physician's office, is widely underused.

Novoste (Norcross, Georgia) said the FDA has approved its premarket approval supplement for the B-Rail 3.5F Delivery Catheter and that it intends to immediately begin re-release of the product to customers. The PMA supplement was filed, and improvements were made to the catheter, after the company initiated a voluntary recall of the product last August. The improved B-Rail 3.5F Delivery Catheter has undergone changes in manufacturing and specifications, "resulting in a more robust tip and positioning the product as a competitive vascular brachytherapy device in the market, based on comparative testing submitted to the FDA in the PMA supplement," the company said. Novoste also reported the introduction of the B-Cath 5F 60 mm XL Delivery Catheter, an addition to the 5F product line that capitalizes on customer demand for longer catheter lengths and enables clinicians to use the company's longer 60 mm radiation source train for coverage of long lesions.

Orthometrix (White Plains, New York) reported the launch of its Galileo 2000 system in the rehabilitation and physical therapy markets. The Galileo 2000 is a powered exercise system already in use in the European and recently introduced in the Japanese rehabilitation and physical therapy markets. The system will be marketed under an exclusive licensing arrangement, its primary applications being to improve muscle strength, reflexes and joint motions in healthy individuals; to exercise and/or redevelop postural muscles, joints and reflexes after injury/disease; and to allow osteoarthritis and Parkinson's disease patients to benefit from exercise that can improve their mobility and/or slow the progress of their disease.

PhotoMedex (Radnor, Pennsylvania) has published on its web site three new CPT codes covering Xtrac laser therapy for inflammatory skin disease and the applicable descriptors. In addition, it said that the Centers for Medicare & Medicaid Services (CMS) have published on its web site the corresponding relative values and national Medicare reimbursement rates for each of these codes. The new codes are effective Jan 1. The CMS designation for laser treatment of inflammatory skin disease (psoriasis) was broken into three distinct codes based on total area being treated: 96920, designated for the total area less than 250 square centimeters, assigned a national payment of about $142.51; 96921, designated for the area 250 to 500 square centimeters, assigned a national payment of about $145.97; 96922, designated for the area of more than 500 square centimeters, assigned a national payment of about $201.31. PhotoMedex develops excimer laser and fiber optic systems and techniques directed toward dermatological applications. It said that the Xtrac laser system is the first FDA-approved excimer laser system to treat vitiligo.

Primary Technology (Tampa, Florida) reported that the FDA has granted 510(k) clearance for its SpectraPulse Intense Pulsed Light product, calling it "a state-of-the-art aesthetic medical device" for the removal of benign pigmented lesions and vascular lesions on Fitzpatrick Skin Types I - IV. Primary Technology said it also is seeking 510(k) clearance for the SpectraPulse product for removal of black and brown hair, also for Skin Types I - IV. Primary Technology manufactures intense pulsed light devices used in aesthetic applications, including hair removal, non-invasive treatment of vascular lesions and pigmented lesions.

Smith & Nephew (London) reported receiving FDA 510(k) clearance for its Achieve brand computer-assisted instruments and software for the accurate placement of the acetabular cup during hip replacement surgery. While the Achieve technology can be used in a conventional hip surgery, it also enables total hip replacement surgery through a mini-incision, providing a reduction in the soft tissue trauma and long rehabilitation normally associated with the procedure. Using traditional techniques, surgeons have a view of the hip cup's abduction, or angle of inclination, but must estimate its anteversion, or lateral angle, due to restricted visualization during surgery. As a result, studies indicate as many as two-thirds of all acetabular cups are placed incorrectly and are at increased risk of post-operative dislocation. The Achieve surgical application, however, expands orthopedists' view of the surgical site, even through mini-incisions, by using specialized technology to track the movement of the instruments and implant relative to the patient's anatomy. The software provides the surgeon with on-screen views of both the cup's abduction and anteversion, thus ensuring the cup's precise placement.

Excimer laser developer Spectranetics (Colorado Springs, Colorado) reported at last month's Interventional Symposium on Endovascular Therapy in Miami Beach, Florida, that data from its Laser Angioplasty to treat Critical Limb Ischemia (LACI) pivotal Phase II clinical trial showed promising results. Just two days later, the company filed a premarket approval supplement (PMA-S) based on that positive LACI trial data. The study data, on which the PMA-S was based, showed that six-month survival with limb salvage, which is the primary clinical endpoint of the study, was achieved in 93% of the limbs treated compared with 87% in the control group. Additionally, significant adverse events in treated patients were nearly one-half that of the control group at 33% and 60%, respectively. The trial enrolled 145 patients (155 limbs) at 14 domestic and several European sites. The control group was comprised of 789 patients with critical limb ischemia treated with a variety of standard therapies. Outcomes for this group were published in The Annals of Internal Medicine in 1999. Spectranetics said it hopes that the PMA-S backed with the data from the LACI trial will soon result in another approval for its CVX-300 excimer laser, already cleared by the FDA for multiple cardiovascular procedures, including coronary atherectomy, the treatment of in-stent restenosis prior to radiation therapy and the removal of problematic pacemaker and defibrillator leads. The trial included the use of coronary catheters as well as larger-diameter catheters ranging from 2.2 mm to 2.5 mm. The company also has another trial under way, the Peripheral Excimer Laser Angioplasty (PELA) trial, which deals with blockages in arteries in the upper leg. That trial is about two to four months behind LACI, Spectranetics said, because the enrollment period was a little bit longer.

SpectRx (Norcross, Georgia) said its SimpleChoice diabetes subsidiary will market the first Level 1-certified over-the-counter fingerstick hemoglobin A1c (glycohemoglobin) test for people with diabetes. The company said Level 1 certification means the SimpleChoice A1c test has met the highest analytical standards of the National Glycohemoglobin Standardization Program. The SimpleChoiceA1c will address an estimated $165 million market, the company said. Keeping A1c levels below 7% will minimize diabetes complications such as blindness, stroke, heart disease and kidney failure. Results from the mail-in test may be reported electronically to the patient or designated physician within 24 hours of receipt by the lab. The test also includes a calculated mean blood glucose a value relating the average glucose concentration over the past 90 days. Mark Samuels, chairman and CEO, said SpectRx plans to launch its SimpleChoice easy, a 30-degree infusion set, early this year, followed later in 2003 by a 90-degree infusion set and a patch infusion set. The company also has developed the SimpleChoice reservoir, a disposable, single-use cartridge for insulin pumps.

SurgiLight (Orlando, Florida), which focuses on the development of laser systems for various ophthalmic applications, reported results from the first two clinical trials previously cleared by the FDA under an investigational device exemption (IDE) to test reversal of presbyopia using its OptiVision system. After one to two weeks, all of the 10 patients treated at two U.S. sites were abile to read the daily newspaper without the aid of glasses, while six of the 10 showed successful accommodation optimal overall eyesight at varying distances (increased accommodation of one to three diopters). The trials were conducted at the Weill Cornell Medical Center at New York Presbyterian Hospital and at the Las Vegas, Nevada, clinic of Jon Siems. Presbyopia involves diminishing visual acuity affecting millions of individuals, usually over the age of 40, worldwide.

Tm Bioscience (Toronto, Ontario) said it launched, ahead of schedule, its first genetic test products. The Tag-It Mutation Detection Kits for coagulation will be used to identify patients with an elevated risk of developing blood clots, an important factor when considering surgery, hormone replacement therapy or hormone-based birth control methods. The Tag-It Mutation Detection line of products offers a high-throughput system with demonstrated accuracy. Tm Bioscience said it would launch an initial series of tests over the next year that also includes tests for cystic fibrosis and drug metabolism, with additional tests to follow. The company's initial commercialization efforts include enabling large commercial diagnostics labs to gain early experience with its technology, toward encouraging their adoption of the broader menu of products that will be available later in 2003.

V.I. Technologies (Vitex; Watertown, Massachusetts) reported enrollment of the first patient in the Phase III program for the Inactine pathogen reduction system for red blood cells. The patient was enrolled in the chronic transfusion support study on Dec. 31. The pivotal Phase III program comprises two studies to evaluate the safety and effectiveness of Inactine-treated red blood cells. One study involves cardiac surgical patients requiring acute transfusion support, and a second study is in patients requiring chronic transfusion support. The two studies are expected to enroll 270 patients combined: 200 patients in the acute surgical transfusion support setting and 70 patients in the chronic transfusion support setting. Both studies are designed as multi-center, double-blind, controlled and parallel-group studies. Vitex's Inactine technology, currently in Phase III clinical trials, is designed to inactivate a wide range of viruses, bacteria and parasites, and has demonstrated its ability to remove prion proteins, while preserving the therapeutic properties of red blood cells. The technology works by binding to the RNA or DNA of the pathogen. Once bound, the compound forms a bond to the pathogenic nucleic acid, preventing replication and thereby "killing" the pathogens.