Orthopedic biomaterials developer Orthovita (Malvern, Pennsylvania) last month received FDA 510(k) clearance to market Vitoss Scaffold FOAM Bone Graft Material. The new material is based on Orthovita's ultra-porous Vitoss Scaffold technology and Kensey Nash's (Exton, Pennsylvania) proprietary resorbable biomaterials technology and is described as an extremely versatile platform technology. Orthovita said FOAM Bone Graft Material is expected to form the basis for a wide array of new resorbable products for the repair of bone defects, the first of which is planned for a launch at the American Academy of Orthopaedic Surgeons (Rosemont, Illinois) annual meeting in March in San Francisco, California.
The company said the Vitoss Scaffold FOAM clearance is the first of a series of products expected to emerge from its collaboration with Kensey Nash. The company will develop and commercialize new spine products based on Orthovita's Vitoss Scaffold technology in combination with Kensey Nash's biomaterials that can be brought to market through the FDA's 510(k) regulatory process. Kensey Nash will manufacture any such jointly developed and approved products under the agreement, while Orthovita will market any such products worldwide.
The Vitoss Scaffold FOAM formulation offers surgeons a highly porous, compression-resistant structure capable of absorbing 300% of its own weight in bone marrow, a proven source of bone-healing cells and signaling factors. The company said its unique structure offers significant advantages in guiding the 3-D regeneration of new bone. "We have the ability to shape this FOAM material into any shape we want to so it allows us to do almost custom design work," said Antony Koblish, president and chief executive officer of Orthovita. "It's a very broad platform."
Vitoss Scaffold FOAM becomes highly flexible and pliable when wet, providing surgeons with an easy-to-use material with many applications in repairing common bone defects of the spine, extremities and pelvis caused by trauma or surgery. It can be manufactured in a range of shapes and sizes to correspond to many clinical indications and surgeon preferences.
Koblish said that 80% of the FOAM product is based on Orthovita's Vitoss Scaffold material and "behaves in a very similar way in the body to Vitoss [Scaffold]." He said animal studies have shown that about 85% of the Vitoss Scaffold material is resorbed and replaced by new bone after three to six months.
Elsewhere in the product pipeline:
Abbott Laboratories' (Abbott Park, Illinois) MediSense Products (Bedford, Massachusetts) unit reported the worldwide launch of the Precision PCx 2.2.1 system, an enhanced version of its hand-held, point-of-care blood glucose testing system. Precision PCx 2.2.1 offers several advantages in the areas of test strip performance, sample application, error reduction, ease of use and data management, Medisense said. The system is the only hospital glucose test strip featuring a fill-trigger electrode that minimizes the potential for errors that may occur when not enough blood is applied to the test strip, helping to reduce test strip waste. Precision PCx 2.2.1 also features the capability to interface with Precision Web, the company's web-based data management system.
AmerisourceBergen (Valley Forge, Pennsylvania) launched the AutoMed Efficiency Pharmacy H750, the first radiofrequency identification (RFID)-enabled hospital pharmacy automation and bar coding system for all orders and dosage forms. The AutoMed H750 features Smart Tray, which uses RFID technology to automate and track fulfillment of pharmacy orders across all dosage forms and for all hospital distribution systems.
Amersham Biosciences (Piscataway, New Jersey) said it has enhanced its CodeLink Informatics Solution to help scientists improve productivity further by streamlining data extraction, acquisition and management processes in their gene expression experiments. The suite of tools includes CodeLink Expression Analysis software, new workflows added to the Scierra Microarray Laboratory Workflow System (LWS) and compatibility with Scierra LWS DiscoveryHub platform.
Boston Scientific (Natick, Massachusetts) has received approval from the Japanese Ministry of Health, Labor and Welfare to market its Express coronary stent system. The company plans to launch the product in Japan soon, after it is approved for reimbursement. The Express system was launched last year in the U.S., Europe and other international markets.
Chiron (Emeryville, California) and Gen-Probe (San Diego, California) reported that clinical trials of the Procleix Ultrio Assay, for the simultaneous detection of HIV-1, hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood, plasma, organs and tissue, have begun in the U.S. The test, which will be distributed and marketed by Chiron, adds an assay for HBV to the FDA-approved Procleix HIV-1/HCV Assay. The Procleix Ultrio Assay is designed to detect the presence of all known HIV-1 groups and subtypes and HCV and HBV genotypes in human plasma during the very early stages of infection, when those agents are present but cannot be detected by immunodiagnostic tests. The HBV component of the assay has the potential to reduce the window period between infection and detection of hepatitis B from 59 to 34 days, an improvement of 42% over currently available tests. The new test, initially being evaluated on the semi-automated instrumentation system, will be used at three blood centers in the U.S. under an investigational new drug application.
CPS Innovations (Knoxville, Tennessee), a unit of CTI Molecular Imaging (also Knoxville), reported the granting of a U.S. apparatus patent in connection with the development of a PET/CT scanner. The patent complements the methods patent granted to CPS last year. PET/CT is an imaging technology that combines the biological examination of patients by positron emission tomography with the computed tomography images of the body's structural detail.
DePuy Orthopaedics (Warsaw, Indiana) reported expanded regulatory approval from the FDA of a biologically engineered surgical implant used on rotator cuff injuries to assist with healing after surgery. DePuy received marketing clearance to expand the use of its Restore Orthobiologic Soft Tissue Implant on all the tendons of the rotator cuff, which the company said is the only implant to have this indication. The implant was initially cleared for the reinforcement of weakened soft tissue.
Digene (Gaithersburg, Maryland) reported that its hc2 High-Risk HPV DNA Test, hc2 CT/GC Test, hc2 Gonorrhea (GC-ID) Test and hc2 Chlamydia (CT-ID) Test have been CE-marked in the European Union under the In Vitro Diagnostics Directive. The hc2 High-Risk HPV DNA Test is marketed in Europe as the DNA Pap and is indicated for use either in conjunction with or independent of a Pap test in routine cervical cancer screening of women to detect the presence or absence of high-risk types of HPV and for use following a borderline Pap test result in women to determine the need for colposcopy. The hc2 CT/GC Test, hc2 CT-ID Test and hc2 GC-ID Test are indicated for use in women to identify the presence of chlamydia and/or gonorrhea from cervical specimens.
Encore Medical (Austin, Texas) received premarket approval from the FDA for its Keramos ceramic-on-ceramic acetabular hip replacement. The new system offers younger and more active patients an alternative for improving the long-term performance of artificial hip replacements. Using an alumina ceramic (aluminum oxide) material, the Encore ceramic-on-ceramic system combines material strength and low-wear characteristics to meet the demands of active patients and reduce the frequency of revision surgery. Encore said the market release of this system will make it one of only three companies to offer ceramic-on-ceramic hip implant technology in the U.S.
EP MedSystems (West Berlin, New Jersey) said its Alert CS (Coronary Sinus) deflectable catheter has received the CE mark for sale in Europe. A deflectable catheter allows the physician to deflect its tip to steer the catheter into certain vessels and areas of the heart. The Alert System delivers programmable low energy bi-phasic electrical impulses directly to the inside of a patient's heart to convert atrial fibrillation to a normal rhythm. The electrical impulses are delivered via the Alert catheter used in tandem with an energy source called Alert Companion.
Fischer Imaging (Denver, Colorado) and R2 Technology (Sunnyvale, California) said that clearance has been granted by the FDA for the use of R2's mammography computer-aided detection (CAD) technology with Fischer's SenoScan digital mammography system. Under a development and marketing agreement, Fischer Imaging has integrated R2's CAD technology into the SenoScan system and has exclusive distribution rights to the integrated system. R2's ImageChecker DM analog system also will support CAD analysis of digital images acquired on the SenoScan system. The combination of the dedicated digital and hybrid CAD products form a complete CAD solution, the companies said.
GE Medical Systems (Waukesha, Wisconsin) introduced AutoBone, the latest in its suite of clinical applications. AutoBone uncovers a vascular "roadmap" by allowing clinicians to remove the bone structure from diagnostic images. The removal of these high-density, bony barriers reveals blood vessels that are otherwise hidden in traditional imaging views, optimizing surgical pathways with more precise information to allow for less-invasive clinical procedures. AutoBone software provides automated bone removal imaging from computed tomographic angiography studies for the abdomen and lower extremities. With one click, bony structures can be removed and then restored to create the transparent roadmap.
I-Flow (Lake Forest, California) reported that an abstract of a study of post-surgical pain relief after breast cancer surgery was published in The Journal of Surgical Research. The results of the study showed that the use of ON-Q Post Operative Pain Relief System, a continuous non-narcotic surgical-site pain relief device, following surgery for removal of axillary lymph nodes in patients with breast cancer resulted in statistically significant decreased pain and narcotic use by patients. Additional data presented at the Association for Academic Surgery's annual meeting found that even 90 days after these patients completed treatment with ON-Q they experienced significantly lower pain and disability with movement of the shoulder, suggesting that the use of ON-Q may lead to a reduction in chronic pain after surgery.
Immersion Medical (Las Vegas, Nevada) introduced its beta AccuTouch Hysteroscopy simulator, one of the first commercial gynecological simulators that specifically incorporates training with a hysteroscope while simulating a specific procedure. The new hysteroscopy simulator with Immersion's haptic-feedback technology realistically recreates this procedure on a virtual female patient. Complete with two new modules involving aspects of basic hysteroscopy and myomectomy, doctors can practice hysteroscopy and accompanying procedures such as tumor removal. The company said the high-fidelity hardware and software enable a physician to sense changes in texture, resistance and density making use of life-like cues that improve control, performance and results.
Instrumentation Laboratory (Lexington, Massachusetts) launched its new GEM PCL Plus Coagulation Laboratory, a portable, whole-blood coagulation system designed to provide rapid results for PT, Citrate PT, APTT, ACT-LR and ACT tests. It can be used in conjunction with the GEM Premier 3000 analyzer in the laboratory and in point-of-care settings to create a comprehensive critical care-testing portfolio. The company said the GEM PCL Plus is easy to use, maintenance-free, offers fully automated sample measuring and mixing, and can handle fresh or citrated whole-blood samples. Security features include a mandatory operator/patient ID option to help ensure the safety and accuracy of test results.
IntraLuminal Therapeutics (Carlsbad, California) has received FDA 510(k) clearance to market its peripheral Safe-Cross Total Occlusion Crossing System. The system is designed to give the interventionist real-time feedback as to the proximity of the crossing wire to the arterial wall, plus the capability to use radiofrequency power on the tip of the wire, to assist in penetrating hardened material within the artery. It facilitates safe passage and placement of therapeutic devices for recanalization in native iliac and superficial femoral peripheral arteries. The company anticipates U.S. market launch in 1Q04.
Medicsight (London) has received FDA clearance for two of its computer-aided diagnosis products, enabling U.S. distribution for the first time. MedicHeart is a new software solution that defines and measures plaque burden, providing a more reliable prediction of future coronary disease. MedicColon is designed to replace more invasive and complicated procedures. Medicsight said the advent of computed tomography colonography is the latest technique for imaging the colon; however, it produces more than 1,200 separate images, making radiological interpretation difficult. It said the MedicColon software has the ability to identify, characterize and classify colonic polyps to enable the earliest detection of potential colon cancer. The company said it also has applied for FDA clearance of MedicLung, which will commence commercial trials with a number of medical institutions in the U.S. once approval has been granted, with a view to a full launch in 2Q04.
Medrad (Indianola, Pennsylvania) said its Stellant CT Injection System's dual injection system reduces patient risk and lowers the cost of contrast-enhanced computed tomography (CT) procedures, according to four independent clinical abstracts accepted for publication at the annual meeting of the Radiological Society of North America in Chicago, Illinois, in December. Stellant's dual injection system makes new test injection protocols possible for the first time, including a saline flush that confirms the vein is open before contrast medium is injected, and a test contrast/saline combination that confirms the primary injection will be correctly timed with the CT scanner. These test injections help to ensure a more accurate diagnostic exam, and ultimately reduce the total amount of contrast medium required per procedure.
Medtronic (Minneapolis, Minnesota) reported market introduction in Europe and Canada of the Medtronic Advantage Supra bileaflet mechanical aortic heart valve. Its supra-annular design allows a larger valve to be implanted, thereby optimizing blood flow, a key to reducing the workload on the heart and improving patient outcomes, the company said. The Advantage Supra valve joins Medtronic's standard Advantage mechanical valve in offering SureFlow Technology, a proprietary design engineered to facilitate implantation and optimize blood flow across the valve and through its pivot region. The new Supra model features a polyester sewing cuff shaped to allow the valve to be sutured in place completely above the natural aortic valve position. This allows the valve's two leaflets to open and close outside and above the confines of a small aortic root or in other anatomical situations where flow would be compromised by standard valve placement.
Medtronic MiniMed (Northridge, California) reported the U.S. introduction of Quick-set Plus, a new infusion set used with Paradigm insulin pumps for the treatment of diabetes. The set's new connector improves ease-of-use by rotating at the infusion site and allowing patients to easily connect or disconnect the set in any orientation. The Quick-set Plus infusion set also includes an enhanced cannula, easily inserted into the patient's skin at a 90-degree angle using the company's Quick-Serter auto insertion device. A pre-attached adhesive pad holds the infusion set securely in place.
Medtronic Physio-Control (Redmond, Washington) reported the U.S. commercial launch of the Lifenet EMS electronic patient care reporting system. Using mobile data collection software with a touch-screen mobile PC, the system enables emergency medical services (EMS) paramedics and first responders to electronically capture patient information at the scene of an emergency and wirelessly transfer it to clinical and operational staff for in-depth data management and reporting. Patient heart rhythm and vital signs data captured from a Lifepak 12 defibrillator/monitor also can be automatically transferred to the Lifenet EMS system and added to the patient's record. The Lifenet EMS system is a result of a partnership between Medtronic and Medusa Medical Technologies (Halifax, Nova Scotia). Medusa's Siren ePCR Suite software has been re-branded to be sold worldwide as the Medtronic Lifenet EMS system.
Medtronic Sofamor Danek (Memphis, Tennessee) has received FDA approval for the expanded use of its Infuse Bone Graft with certain sizes of the Infuse Fix and Inter Fix RP Threaded Fusion devices in treating back pain. Using Infuse Bone Graft with the threaded fusion devices reduces the pain and complications associated with treating degenerative disc disease by eliminating the second surgery required to harvest bone from a patient's hip for implantation in the spine, as is done in traditional spinal fusion procedures. Infuse Bone Graft contains recombinant human bone morphogenetic protein, the genetically engineered version of a naturally occurring protein that is capable of initiating bone growth in targeted areas in the spine. It is the only bone graft replacement currently approved by the FDA specifically for treating degenerative disc disease in the lumbar spine.
Medtronic Vascular (Santa Rosa, California) has received 510(k) clearance from the FDA for the Racer Biliary Stent System. The Racer Biliary Stent is immediately available in stent diameters from 4 mm to 7 mm and stent lengths of 12 mm and 18 mm. The Racer Biliary Stent is an over-the-wire balloon expandable stent system designed to maintain bile flow in ducts with severe blockages. The Racer is the first cobalt-alloy biliary stent cleared for use in the U.S. and is specifically indicated for use in the palliation of malignant tumors in the biliary tree. The cobalt-alloy technology allows for thinner stent struts without sacrificing stent strength and visibility, the company said. Because the cobalt-based alloy is denser than stainless steel, the Racer stent maintains optimal radiopacity, allowing it to be easily viewed under fluoroscopy. As a result, the physician can precisely place the stent and more clearly view the clinical result within the anatomy. The Racer stent also is fully MRI-compatible, which permits the use of magnetic resonance scanning without the risk of stent displacement or image distortion.
PHT (Charlestown, Massachusetts) said its LogPad electronic patient diary was deployed as the primary data capture tool for the Centaur Integrated e-Systems in Clinical Trials Conference in London. During the two-day conference, half of all delegates received Wireless LogPads for data input on the first day, with the remaining half using paper diaries to record their information on the second day. The Wireless LogPads work on palmOne TungstenW hand-held devices, and transmit data instantaneously via GPRS networks. Overall compliance on paper was 60.3%, while compliance using the LogPad was 89.4%.
Siemens Medical Solutions (Malvern, Pennsylvania) introduced at the Radiological Society of North America meeting the Magnetom Avanto, its newest high-end 1.5 Tesla magnetic resonance (MR) system based on total imaging matrix technology (TIM). TIM is a seamless, whole body surface coil design that combines 76 seamlessly integrated coil elements with up to 32 RF channels, making true 205 cm (6'9") whole-body imaging possible in a single exam. Siemens said the system allows radiologists to select exams, not coils, and provides the highest acquisition speed without image artifacts or restrictions in coverage, giving radiologists the opportunity to conduct advanced applications. It also features Siemens iPAT, which offers fast image acquisition with parallel imaging in all dimensions.
St. Jude Medical (St. Paul, Minnesota) reported FDA approval of the St. Jude Medical Housecall Plus remote patient monitoring system. The system enables a physician to evaluate and communicate with an implantable cardioverter defibrillator (ICD) patient in real time. The Housecall Plus remote monitoring system currently supports St. Jude's Atlas, Epic and Epic+ families of ICDs.
Texas Instruments (Tucson, Arizona) reported roll-out of an eight-channel, low-noise variable gain amplifier from the company's Burr-Brown product line, designed for medical and industrial imaging applications. The VCA8613 incorporates eight low-noise preamplifiers, eight attenuators and eight post-gain amplifiers. Normally, this functionality and integration would demand substantial power, but the VCA8613 draws only 600 mW (75 mW/channel), making it the lowest-power solution available on the market today, according to the company. The VCA8613 features an integrated continuous wave (CW) processor that allows a reduction in the number of external components required to support the CW Doppler mode (critical in cardio scanning applications).
Thoratec (Pleasanton, California) said the FDA has approved its premarket approval supplement to market the TLC-II Portable Ventricular Assist Device (VAD) Driver for home discharge. The TLC-II is a small, lightweight device used to power the ThoratecVAD, as well as the investigational IVAD (implantable VAD), which pump blood to the body in heart failure patients awaiting transplantation or recovery from open-heart surgery. It is the first biventricular support device to receive such approval, the company said.
Toshiba America Medical Systems (TAMS; Tustin, California) said its Aquilion 16 multislice computed tomography scanner helps enable rapid, accurate diagnosis while minimizing exposure of radiation to pediatric patients. The selectable slice-thickness multi-row detector (SSMD) of the Aquilion 16 allows up to seven varying image slice thicknesses, from 0.5 mm to 0.8 mm, which can be selected based on the objectives of the examination. The Aquilion 16 generates up to 40 slices per second using the SSMD and permits simultaneous 16-slice acquisition per 400-millisecond gantry rotation for volumetric data acquisition.