In a move that clears the way for the next generation of diabetes management technology and perhaps foreshadows the ideal of an artificial pancreas Smiths Medical MD (St. Paul, Minnesota) last month won FDA 510(k) clearance for its CoZmonitor blood glucose module. The company said the device, developed in partnership with Abbott Diabetes Care (Alameda, California), is the first all-in-one combination of glucose monitor and insulin pump. Product development time, including FDA review, was about 1-1/2 years.

"The key [to the device] is the ease of use," Brian Johnson, director of marketing for Smiths Medical, told The BBI Newsletter. "It is much better diabetes management. It is really going to help healthcare professionals analyze what's going on and pinpoint trouble areas, to make therapy changes to help patients manage their diabetes even further."

The CoZmonitor blood glucose module attaches to the back of the Smiths Deltec Cozmo insulin pump to create the all-in-one functionality. The Cozmo insulin pump keypad and screen are used for all blood glucose testing functions and results. The system uses Abbott's FreeStyle Flash technology as well as its FreeStyle test strips, which are readily available to consumers. Abbott will be in charge of manufacturing the device, while Smiths Medical will handle sales and marketing.

Johnson said the development of the monitor was "truly a partnership" between his company and Abbott. Abbott Diabetes Care was formed in April when Abbott Laboratories (Abbott Park, Illinois) acquired TheraSense and combined it with its existing MediSense (Bedford, Massachusetts) business, which Abbott acquired in 1996 to enter the blood glucose monitoring market. The partnership with Abbott Diabetes Care was critical because it enabled use of a proven blood glucose monitoring and test strip technology "rather than creating something completely new. TheraSense had the technology and that's what we wanted," Johnson said. "It made sense."

The system will help to make disease management easier for patients and physicians, Johnson said. "Doctors are always asking patients for log books where they track every blood glucose reading. Well, instead of the individual having to write all of that down, it's all in the Cozmo insulin pump." Patients will be able to go to their device logbook and print out the information. The device also allows users to e-mail information to their doctors, "really streamlining the process," he said.

Smiths Medical said it would begin filling orders in August.

Elsewhere in the product pipeline:

Accuray (Sunnyvale, California) said results from a clinical study of CyberKnife radiosurgery, the first to demonstrate the feasibility of using stereotactic radiosurgery for the treatment of locally advanced pancreatic cancer, were published in the International Journal of Radiation Oncology and Biological Physics. Designed as a dose-escalation study, a total of 15 patients diagnosed with inoperable locally advanced pancreatic cancer were treated and evaluated with three radiation doses in a single treatment session using the CyberKnifeSystem. The authors concluded that radiosurgery is feasible for patients with locally advanced pancreatic cancer, and local control can be achieved at a radiation dose of 25Gy.

Akers Biosciences (Thorofare, New Jersey) said it has received FDA market clearance for its rapid test for Heparin/Platelet Factor-4 (HPF-4) antibodies. The HealthTEST HPF4 Antibody Assay is designed to identify patients at risk for developing heparin-induced thrombocytopenia and thrombosis syndrome, a severe allergic-like side effect associated with the use of the anticoagulant heparin. The company said it would market the HealthTEST HPF4 to hospitals where heparin is administered during surgical and other medical procedures.

Alaris Medical Systems (San Diego, California) reported the full market release of wireless connectivity applications for its Medley Medication Safety System. By wirelessly linking its point-of-care infusion delivery platform with the hospital's information network to create a real-time systems management for its Medley System with the Guardrails Safety Software, the Alaris Network eliminates the need to manually transfer information to and from individual Medley Systems. Instead, data is automatically transmitted between each Medley System and the central server using the hospital's wireless infrastructure.

AngioDynamics (Queensbury, New York) reported the U.S. release of its Dynamic Flow chronic hemodialysis catheter. Designed for long-term use in dialysis patients, the Dynamic Flow catheter's split tip design and proximal shaft reduce the chance of kinking after placement. The catheter also features a Durathane shaft a biocompatible and durable material that offers higher chemical resistance than polyurethane, which the company said helps simplify site care since the material can be cleaned with either iodine or alcohol.

Angiotech Pharmaceuticals (Vancouver, British Columbia) has completed enrollment in its vascular wrap study, nearly six months earlier than anticipated. The company began enrollment in the trial last October. The study involves the placement of paclitaxel wraps around the distal anastomosis (i.e., the anastomosis downstream from blockage or the one farthest down the leg) in patients needing implantation of a synthetic bypass graft.

Axya Medical (Beverly, Massachusetts) said it has demonstrated technological advances with its Axya Sonic Scalpel ultrasonic surgical system to its ultrasonic technology platform. The system, for which Axya received 510(k) clearance last September, will be used for cutting and coagulation of soft tissue structures in endoscopic and open surgical procedures. The company is seeking partners for commercialization of the system.

Bayer HealthCare Diagnostics (Tarrytown, New York) said its BNP (B-type natriuretic peptide) test for cardiac patients has received FDA approval for two additional claims: the prediction of survival in patients after myocardial infarction in conjunction with other risk factors, as well as assessment of heart failure severity in patients diagnosed with congestive heart failure (CHF). The proportional increase in BNP concentration is about twofold as heart failure severity increases from New York Heart Association Class I to II, II to III, III to IV, the company said. The BNP test has a greater than 99% negative predictive value in ruling out heart failure, Bayer said.

BioLucent (Aliso Viejo, California) said a recently published study by Swedish mammographer Laszlo Tabar, MD, confirmed that the company's MammoPad breast cushion significantly reduces the discomfort many women feel during mammograms. Gail Lebovic, MD, co-director of the Lee Breast Center at USC/Norris Comprehensive Cancer Center (Los Angeles, California) and associate professor of clinical surgery at Keck School of Medicine, is a co-author of the study, which appeared in the April issue of the journal Acta Radiologica. The study involved 838 Swedish women who received routine screening mammograms. Two-thirds of the subjects reported the cushion significantly reduced discomfort.

The FDA has cleared Cook's (Bloomington, Indiana) next-generation Zenith Flex AAA Endovascular Graft for U.S. distribution. The company also released two-year data on the original Zenith abdominal aortic aneurysm (AAA) device, which was cleared by the FDA last year. According to the company, the Zenith Flex AAA graft system features several significant innovations over the previous iteration of the Zenith device originally approved for sale in the U.S. in May 2003. These features include more widely spaced stent bodies to allow the device to conform to tortuous anatomy. The new design also decreases the Zenith FLEX stent-graft's kink radius by 40% to 68%, allowing the device to bend around tighter turns in the aorta with less chance of kinking.

DiaSys (Waterbury, Connecticut) said it presented additional patent claims for its in vitro assay technology to detect and monitor kidney disease. The company said kidney malfunction may go undetected by current methods of testing until 80% or more of the kidney is damaged. The Diasys technology is quick, easy to use and inexpensive, providing front-line testing for early detection before the kidney degenerates or fails. The claims include monitoring, screening and adjunctive testing for renal (kidney) insufficiency and renal due to diabetes, hypertension and monoclonal gammopathies. DiaSys also has presented an additional device claim to include a home testing configuration of its technology.

Diagnostic Ultrasound (Bothell, Washington) reported the introduction of the Mobile BladderScan BVI 6400, a hand-held, noninvasive ultrasound instrument that rapidly determines bladder volume. The BVI 6400 saves a minimum of 10 exams, each associated with a voice annotation, so healthcare providers can conveniently scan multiple patients on their rounds, the company said. The Mobile BladderScan uses patented V-mode 3-D ultrasound technology to measure bladder volume noninvasively. It features voice annotation and multiple exam storage capabilities, with a scan time of about five seconds. Users can view, save and print ultrasound images and bladder volume measurement results from Mobile BladderScan exams using ScanPoint, Diagnostic Ultrasound's online service.

Digirad (San Diego, California) reported the introduction of its Cardius-1M system, which it believes represents a significant advance in nuclear cardiac imaging by offering physicians greater flexibility through an upgradeable mobile platform that is expandable with evolving practice needs. The Cardius-1M system is comprised of a solid-state nuclear gamma camera, an upright imaging chair, an acquisition/processing station and Digirad's third-generation Solidium solid-state detector. The lightweight system offers a small footprint, which allows it to fit into a 7 foot x 8 foot space without the need for room renovations. The company said the upright and open architecture of the patient chair used with the Cardius-1M system can increase patient comfort and reduce the incidence of claustrophobia. The Cardius-1M system is designed for compatibility with other Cardius series imagers.

DOBI Medical International (Mahwah, New Jersey) said it has reached agreement with the FDA regarding the clinical study of the ComfortScan system the company will conduct as its final step in its premarket approval application. The ComfortScan system, an advanced imaging device, was created to provide a new means for the improved diagnosis of cancer though the detection of angiogenesis associated with tumors. The study, expected to commence in 3Q04, will take place at about a dozen research sites in the U.S. and will involve the enrollment of up to 600 patients previously referred to biopsy following a suspicious or indeterminate initial finding. At the end of the clinical study, an independent group of physicians, blinded to the results of the biopsied patients, will interpret the scans acquired by the ComfortScan system.

Dusa Pharmaceuticals (Wilmington, Massachusetts) reported the launch of a pilot Phase II clinical trial for the treatment of high-grade dysplasia (HGD) within Barrett's esophagus, using Levulan (ALA, or aminolevulinic acid) photodynamic therapy. This single-site U.S. trial is being carried out to gather treatment data using the company's new endoscopic light delivery system. In the trial, at least eight patients with HGD will receive 60 mg/kg Levulan orally, followed four to six hours later by 150 J/cm2 of 635 nm of red laser light delivered using Dusa's new endoscopic sheath device, designed to enable direct visualization of the target area for optimal placement of the light-carrying fiber optic. The design also is meant to deliver light evenly and circumferentially, compared with current methods of light delivery.

Exactech (Gainesville, Florida) said the FDA has cleared for U.S. distribution both the InterSpace Knee Spacer, a pre-formed antibiotic knee spacer, and Cemex Genta, an antibiotic bone cement, produced by Tecres SpA (Verona, Italy), and distributed in the U.S. by Exactech. InterSpace Knee allows the patient assisted mobility between the first and second stages in two-stage revision treatment of infected total knee replacements. The spacer also provides release of antibiotic into the local infected area. Cemex Genta bone cement is designed for use in placement of the definitive implant following treatment of infected total joint replacements. The formula contains antibiotic and 33% less monomer than traditional bone cement systems, resulting in less heat and minimizing the potential for thermal necrosis and less contraction of bone cement during polymerization.

iCAD (Nashua, New Hampshire) said it has received FDA approval for release of its Second Look 200 system for early detection of breast cancer with substantially improved cancer detection software. The new combination of Second Look 200 with iCAD's Version 6.0 cancer detection software is designed to make computer-aided detection (CAD) accessible to smaller breast care centers. It can analyze up to 15 cases per day, is fully automated, fits on a counter top and is priced below $70,000. Version 6.0 detection software offers up to 94% sensitivity to all breast cancers. The company said the Second Look 200 system also will be made available on a fee-per-procedure basis it calls "ClickCAD."

I-Flow (Lake Forest, California) has been given additional clearance from the FDA for its ON-Q system of narcotic-free pain relief systems that will allow the company to state that it "significantly" reduces pain and the need for narcotics following surgery. The clearance also allows I-Flow to label the device for specific surgeries. Currently, the labeling is for all surgeries. A company official said, "We basically can now say that patients will get significantly better pain relief than with narcotics alone." A second claim that ON-Q can now make is that "when ON-Q is used, it significantly reduced the amount of narcotics that are needed to relieve pain following surgery." ON-Q consists of a small balloon pump that delivers local anesthetic directly to the surgical site through a catheter that is inserted by the surgeon during the surgery. ON-Q can deliver between two and five days of pain relief, depending on the size of the kit purchased and depending on the type of surgery performed

LuMend (Redwood City, California) said it is launching the Frontrunner XP Chronic Total Occlusions (CTO) Catheter platform as part of its new peripheral vascular strategic initiatives. The XP family of catheters is based on the Frontrunner X39 coronary CTO Catheter and is designed to provide enhanced performance in crossing occlusions in the peripheral vasculature. The 4.5 Fr Frontrunner XP CTO Catheter is designed to address the demands associated with the specific anatomical and lesion characteristics often found in the peripheral vasculature. The XP, which can be delivered through a 6 Fr guide catheter, incorporates a more flexible shaft designed to optimize delivery performance, enhanced tip shape-ability and an improved polymer formulation designed to improve handling and crossing performance. The XP is available in lengths of 90 cm and 140 cm.

Patients with osteoporotic vertebral compression fractures treated with Cortoss Synthetic Cortical Bone Void Filler made by Orthovita (Malvern, Pennsylvania) show a significant, rapid reduction in pain and restoration of function maintained 12 months after treatment, according to the preliminary results of a recent U.S. pilot phase IDE study. The 12-month study results were presented at EuroSpine 2004. In the vertebroplasty treatment technique used in this study, low volumes of Cortoss were injected percutaneously into the fractured thoracic or lumbar vertebra (T6-L5) to stabilize and restore load-bearing capability. The three-site study involved 20 patients with compression fractures affecting a total of 26 vertebrae. The average age of study participants was 72. Using a Visual Analog Scale (VAS) to measure pain levels, patients in the study who had a mean baseline pain score of 74.1 now reported a mean pain score of 28.2 at the 12-month follow-up, representing a 62% reduction in pain, consistent with the pain reduction reported at the 72-hour post-op, three-month and six-month follow-up intervals.

Medtronic (Minneapolis, Minnesota) reported the launch of the InSync cardiac resynchronization therapy system in Japan. InSync is an implantable device about the size of three large stacked coins that helps resynchronize the left and right sides of the heart so that it pumps blood more efficiently. Medtronic said it is the only company offering cardiac resynchronization therapy to patients with heart failure in Japan. Medtronic also reported the European market release of the InSync Sentry cardiac resynchronization therapy defibrillator (CRT-D). It said the InSync Sentry is the first CRT-D device with automatic fluid status monitoring, which can be programmed to alert patients and clinicians to changes in fluid accumulation in the lungs and thoracic cavity. The OptiVol Fluid Status Monitoring feature measures changes in intra-thoracic impedance, which is an indication of a patient's changing fluid volume. Physicians set a threshold for each patient, and when the threshold is crossed, the patient and clinician are alerted. InSync Sentry offers a small size (40 cc) with increased longevity and delivers 35 joules of energy.

Merge eFilm (Milwaukee, Wisconsin) reported the release of Fusion PACS version 1.2.7, an integrated repository of healthcare information and suite of software application modules that provide picture archiving and communications system (PACS) functionality and web distribution on a scalable integrated server platform. The company said that for physicians who refer patients for radiological studies, the enhanced version will provide improved web-based accessibility to images and reports, as well as bring new image manipulation capabilities for referring physicians to utilize in patient care. The image manipulation tools are similar to those in Merge eFilm's eFilm Workstation software, which the company said is used by thousands of radiologists worldwide.

MIV Therapeutics (Vancouver, British Columbia) said its Hydroxyapatite (HAp) ultra-thin "passive" stent coating has passed the Rabbit Pyrogen Test (material mediated), confirming that the coating is non-pyrogenic and does not induce fever. Biocompatibility is one of the key features that differentiate MIVT's HAP coating technology, the company said. The Pyrogen Test, performed by Toxikon (Bedford, Massachusetts), was designed to determine the presence of chemical pyrogens in extracts of solid materials in order to limit risks of febrile reaction in a patient.

Nanosphere (Northbrook, Illinois) said its researchers have developed a colorimetric detection capability for its nanoparticle-based molecular detection systems designed to simplify identification of genomic DNA, RNA and protein targets without the need for traditional signal or target amplification. The capability was established using the company's ClearRead technology its core technology and it was used to identify the mecA gene, a biomarker associated with the challenging methicillin-resistant Staphylococcus aureas (MRSA). The findings were published in the July issue of Nature Biotechnology. In viewing the results of the newly determined colorimetric capability, researchers saw a green-to-orange color change that detected the presence of the targeted mecA sequence from clinical samples of MRSA, the company said.

Possis Medical (Minneapolis, Minnesota) reported receiving two marketing clearances from the FDA. The AngioJet Xpeedior 120 catheter and the AngioJet Power Pulse Spray Ancillary Kit have been cleared for the infusion of physician-specified fluids into the peripheral vascular system. The FDA also cleared the 0.014" GuardDOG Occlusion Guide Wire System for use in the peripheral vasculature to facilitate the infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. Possis said it expected both of these products to undergo initial market testing at a limited number of clinical sites last month, and they are expected to be in full commercial release beginning in August.

Rafael Medical Technologies (Dover, Delaware) has received CE mark approval for the SafeFlo Retrievable Vena Cava Filter for the prevention of pulmonary embolism as well as for the VascuGrasp Retrieval System, a foreign body retrieval device used to remove the SafeFlo filter from the vena cava. The SafeFlo filter is based on shape-memory Nitinol wires and a design that provides an alternative anchoring mechanism to the standard strut-based filter design. SafeFlo's low-profile, vessel-friendly design affords simple and safe filter implantation with the ability to fully deploy, retrieve and reposition prior to detachment, the company said. As a retrievable or "optional" filter, SafeFlo has been demonstrated to be fully retrievable up to 21 days post-implantation. Rafael Medical said it expects to launch SafeFlo and VascuGrasp in selected European markets later this year.

Revivant (Sunnyvale, California) reported that five centers are participating in the AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial to evaluate the safety and effectiveness of its AutoPulse Resuscitation System, an FDA-approved external device that is portable and designed to provide consistent automated chest compressions during cardiopulmonary resuscitation. During the one-year study, half of the patients will receive manual chest compressions and the other half will receive compressions with the AutoPulse. Patients who survive and agree to continue to participate in the study will be followed for three months after the event. At the conclusion of the study, the researchers will compare the two methods to see which group of patients had a better outcome.

Rochester Medical (Stewartville, Minnesota) reported FDA clearance for the advanced Hydrophilic Antibacterial Intermittent Catheter. The company said it will introduce the advanced catheter to the market this fall under the Rochester Medical brand, and thereafter through private-label arrangements. The single-use, disposable catheter combines the company's Infection Control Antibacterial Technology and its Hydrophilic Surface Technology into a single device. The result is a device that gently medicates the urethral tract during each catheterization and is designed to minimize the incidence of infection often associated with use of intermittent catheters.

Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of Ultrabraid, a high-strength polyethylene suture for attaching soft tissue to bone. Ultrabraid is made of a polyethylene fiber with a proprietary braid configuration. It slides through tissue and anchors easily, resists fraying and creates a stronger knot than traditional suture. Ultrabraid will come loaded on Smith & Nephew's Twinfix line of suture anchors, which are used to repair shoulder injuries to the rotator cuff.

Spectranetics (Colorado Springs, Colorado) said it has received conditional approval from the FDA to begin the Extended FAMILI clinical trial, which will study the use of the company's excimer laser catheters to treat heart attack patients. The goal of the study is to determine if treating the heart attack with the laser restores blood flow and reduces the infarct size. The feasibility trial will enroll 80 patients at up to 20 multi-national sites. The trial has been initiated in Europe, and 13 patients have been enrolled at five sites. For each patient, study endpoints include the re-establishment of blood flow in the blocked artery creating the heart attack, the ability of blood to flow into the heart muscle as seen on the electrocardiogram and the amount of tissue damaged by the heart attack.

Trimedyne (Irvine, California) reported the issuance of U.S. patent No. 6,740,107, which covers new, minimally invasive laser devices designed to treat mitral valve regurgitation. The patent covers designs for two new laser devices to treat this condition; one for use by surgeons during bypass surgery, and one for use by cardiologists in the cath lab through a puncture in an artery in the groin.

Whatman (Clifton, New Jersey) reported three new products within its Whatman FTA product family for the collection and customization of biological samples. The products Whatman PlantSaver Card, Whatman FTA Kit, and Whatman SPOT Holder are used in field and laboratory collection of plant species, blood or buccal cells and bacterial clones. Whatman FTA is designed to allow for the safe and rapid isolation of pure DNA at room temperature. Whatman PlantSaver is a four-square version of the FTA card with a laminated flap that strengthens the card and makes it more robust and suitable for field collection and easy transport of plant samples. The Whatman SPOT Holder is a metal frame that allows automated spotting to Whatman FTA cards by holding the cards flat, compatible with any liquid-handling system.

Wright Medical Group (Arlington, Tennessee) reported the domestic launch of the Advance Double-High Total Knee System. Part of Wright's flagship knee line, the Advance Double-High Knee is designed to provide the patient with high flexion and high stability without sacrificing the posterior cruciate ligament (PCL). The Advance Double-High Knee design addresses an adverse phenomenon, known as paradoxical motion, that often occurs with other PCL-retaining knee systems. This movement prevents the prosthetic knee from flexing in a stable, consistent manner like a normal knee and can result in abnormal gait and reduced flexion. The Advance maximizes PCL function.

Listening to the heart with a stethoscope is the most widely used method for the detection of heart murmurs, but Zargis Medical (Princeton, New Jersey) has developed an auscultatory device it hopes will become the new standard of care. The Zargis Acoustic Cardioscan, cleared by the FDA earlier this month, is the first computer-aided device to support primary care physicians in analyzing heart sounds for the identification of suspected murmurs, a potential sign of heart disease. It improves upon a stethoscope which is subject to the limitations of the human auditory system by electronically acquiring, processing and analyzing heart sounds and providing printable results. If a murmur has been detected, the Cardioscan assists physicians in their referral decision to a specialist or for further testing.

Zoll Medical (Chelmsford, Massachusetts) said the FDA has granted marketing clearance for the new pediatric capability in its automated external defibrillator, the AED Plus. This capability, for children up to 8 years of age, is now available to customers and distributors in the U.S. and worldwide. The pediatric capability includes voice prompts that tell rescuers what type of electrodes are connected, so that the proper electrodes are used for adults or children. Separate and specific algorithms for adults and children are used to analyze a victim's heart rhythm. Pediatric-specific energy levels also have been incorporated. Electronics adjust defibrillating energy levels automatically so that suitable doses, when needed, are delivered.

ZymeQuest (Beverly, Massachusetts) said that Brigham and Women's Hospital (BWH; Boston, Massachusetts) has granted it an option to license the worldwide rights to a new method of treating and chilling blood platelets that may prolong their shelf life by a week or more. Under a joint invention agreement, BWH and ZymeQuest share the proprietary rights to the technology. ZymeQuest's product development and commercialization goals under the proposed licensing agreement are to optimize the techniques for platelet modification, produce a galactose modification delivery system, conduct clinical trials, develop a commercializable modification protocol, gain regulatory clearance and market the product to hospitals and regional blood centers.

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