Abbott Laboratories (Abbott Park, Illinois) and OraSure Technologies (Bethlehem, Pennsylvania) agreed to co-market a rapid HIV test that detects the presence of its antibodies in as little as 20 minutes.
Abbott will distribute the test to the laboratory markets at hospitals and physicians' offices. OraSure will sell the test in public health and criminal-justice markets. OraSure gets nonexclusive rights to certain Abbott patents on a test strip technology, for which OraSure will pay up-front fees and ongoing royalties.
Last month, OraSure received FDA approval for the OraQuick Rapid HIV-1 test, subject to certain conditions. It delivers results while a patient remains at the clinic, allowing doctors to set a treatment regimen. Doctors say this is important because, in about one-third of cases, patients never return to the clinic to receive their HIV test results, potentially exposing others to the virus.
Elsewhere in the product pipeline:
Alliance Pharmaceutical (San Diego, California) presented at the American Society of Echocardiography meeting in Orlando, Florida, data from a Phase III study for Imagent (perflexane lipid microspheres), an ultrasound-imaging agent recently approved by the FDA. Imagent, a suspension of perfluorohexane-filled microspheres with flexible lipid shells, was administered intravenously. Data from the randomized, controlled, 409-patient trial showed a statistically significant improvement in total endocardial border delineation scores with the use of Imagent. Clinicians added that use of Imagent during echocardiographic imaging resulted in a greater than three-fold improvement in segmental wall motion scoring accuracy with MRI. Imagent is manufactured from synthetic materials and packaged as a dry powder in a ready-to-use kit that is stored at room temperature.
Bristol-Myers Squibb Medical Imaging (North Billerica, Massachusetts) presented at the American Society of Echocardiography meeting study results showing that ultrasound contrast agents, such as its Definity, can provide a reliable second opinion to evaluate cardiac wall motion in difficult-to-image patients. Approved for patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, Definity increases the power of echocardiography to enable clearer visualization of the heart than echocardiography alone. In the 52-patient study, 15 were found to have normal wall motion. Data were used as a preference for detecting wall motion abnormalities in the remaining 37 patients. Results of the automated detection system's evaluation were compared against other interpretations and demonstrated an overall agreement rate of 86%.
Boston Scientific (Natick, Massachusetts) submitted a CE mark application for its Taxus paclitaxel-eluting stent system. The company added that after receiving regulatory approvals in additional countries, it has expanded the commercialization of the Taxus product through the WISDOM transitional registry program. Boston Scientific is conducting the registry in a number of countries as part of a limited commercial launch. "The application for CE mark is further evidence that we are on track to launch in Europe later this year," said Jim Tobin, president and CEO. The TAXUS series of clinical studies, now up to TAXUS IV, is designed to collect data on Boston Scientific's paclitaxel-eluting stent technology for reducing coronary restenosis. The TAXUS IV trial has enrolled 1,172 patients, the target patient number for the trial, and the follow-up period has begun for those patients. Boston Scientific has said it expects to launch paclitaxel-eluting stents in Europe this year and in the U.S. in 2003.
Cardima (Fremont, California) reported preliminary data from its Revelation Tx Phase III trial for the treatment of atrial fibrillation (AF), indicating that 97% of patients had a greater than or equal to 50% reduction in AF episodes, and 50% reported no recurrence. A Phase II study indicated that, at six-month follow up, 87% of 37 patients had a greater than or equal to 50% reduction in AF episodes, and 48% reported no recurrence. Cardima said it expected to complete the necessary six-month Phase III follow-up last month and plans to submit in 3Q02 a premarket approval application. The Revelation Tx is a minimally invasive, single-use system.
CardioGenesis (Foothill Ranch, California) said clinical data from four studies of transmyocardial revascularization (TMR) performed with its Holmium:YAG laser show it to be effective in producing sustained relief from severe angina in patients suffering from chronic cardiovascular disease. One showed 82% of selected patients experienced "excellent" sustained relief from angina pain with either no angina pain or only Class 1 symptoms at follow-up. Another showed that TMR provided an improved revascularization for the treated patient population, and there was no operative mortality in the patients, all patients were discharged with angina relief, and there were no re-admissions for cardiac symptoms.
Cochlear Americas (Denver, Colorado) received FDA approval of the Nucleus 24 Double Array cochlear implant for use in patients with ossification in their cochlea (inner ear). Such bone growth may block the space inside the cochlea preventing the use of conventional cochlear implants, which consist of a single array of electrodes. The company said the Nucleus 24 Double Array, developed in collaboration with Professor Lenarz at the ORL Clinic of Medical University Hannover (Hannover, Germany), allows patients with significantly ossified cochlea to gain the benefits of cochlear implantation by offering two shorter electrode arrays. These shorter electrodes arrays are surgically implanted into two different positions in the cochlea, bypassing ossification that may be obstructing the passageway.
Computerized Medical Systems (CMS; St. Louis, Missouri) launched at the American Association of Physicists in Medicine meeting in Montreal, Quebec, its latest-generation radiation therapy treatment planning system called XiO. Its file menu and icon style of interface builds on a user's familiarity with common business software applications. CMS said its productivity is further enhanced by its library storage of favorite graphic layouts and beam set-ups.
Confluent Surgical (Waltham, Massachusetts) began its pivotal U.S. trial for the SprayGel Adhesion Barrier, the Prevention of Pelvic Adhesions In Laparoscopic surgery (PREVAIL) study. The first procedure in the PREVAIL study was performed last month by Michael Twede, MD, and Dale Sundwall, MD, medical directors at the Salt Lake City Women's Center (Salt Lake City, Utah). The SprayGel Adhesion Barrier System received the CE mark in November 2001, and has been introduced in major European markets and Australia.
Cook (Bloomington, Indiana) submitted to the FDA for premarket approval its Zenith AAA Endovascular Graft, a third-generation endovascular graft system that matches the anatomy of patients being treated for abdominal aortic aneurysm (AAA). The system includes features to improve fixation and reduce stent-graft leakage. It has been clinically shown to lower morbidity rates, reduce recovery time and improve quality of life for patients undergoing endovascular AAA repair compared to open surgical procedures. Patients treated with Zenith require two incisions in which to insert two catheters into the femoral arteries. Once the catheters are guided into position, a fabric-covered, self-expanding metal stent-graft is deployed inside the weakened section of the aorta and the surrounding vessels to relieve pressure.
CryoCath Technologies (Kirkland, Quebec) began U.S. sales and commercialization activities of its SurgiFrost Surgical CryoAblation System as its partner Endocare (Irvine, California) received FDA 510(k) clearance for SurgiFrost. The clearance specifically covers the embodiment of several technologies including a 6 cm probe optimized for creating linear ablations. The SurgiFrost probe is used to ablate cardiac tissue while a patient is undergoing a primary cardiac surgical procedure, such as coronary artery bypass grafting or mitral valve replacement and/or repair. SurgiFrost is a malleable, single-use cryosurgical probe developed to surgically treat cardiac arrhythmias.
Current Technology (Vancouver, British Columbia) published in the May/June issue of Psycho-Oncology the results of a pilot research study that examined whether ETG (electrotrichogenesis) could prevent or reduce hair loss in women with breast cancer undergoing CMF chemotherapy. Twelve of the 13 female patients in the study had good hair retention during chemotherapy and at the end of the study, suggesting that ETG treatment had a positive impact on quality of life. There were no reported side effects attributable to ETG. The findings of a 1998 breast cancer patient study indicate that over 90% of women surveyed considered hair loss to be one of the most troublesome side effects of cancer treatment. The company said reducing alopecia, secondary to chemotherapy, has the potential to increase CMF chemotherapy treatment compliance, enhance patient self-esteem and improves overall quality of life during this stressful period.
Endologix (Irvine, California) demonstrated its PowerLink System during the Paris Course on Revascularization on a 66-year-old male suffering from an abdominal aortic aneurysm (AAA). He left the operating room after the successful procedure in 24 minutes. The PowerLink System was delivered to the site of the aneurysm through the artery of the leg, eliminating a need for abdominal surgery. Clinicians said the device is the only single-piece system with integral support. Its design provides for rapid delivery, and it adopts a stable position within the aorta thanks to the self-expanding endoskeleton. Endologix, which recently announced a merger with Radiance Medical Systems (also Irvine), next plans to enroll and follow its U.S. pivotal study of the PowerLink System, obtain Japanese clearance for the procedure and build sales revenue in Europe.
Galil Medical (Yokneam, Israel) reported at the American Urological Association meeting in Orlando, Florida, results of a University of Mississippi Medical Center (Jackson, Mississippi) study that used its Plug&Freeze cryosurgery equipment. Sixty-four patients with a total of 72 tumors were enrolled. The cryosurgery was performed under MRI guidance, enabling excellent imaging of the target tissue. Results showed that 93% of patients had no radiographic evidence of local disease recurrence, and 95% went home within 24 hours, with minimal morbidity associated with the procedure. Galil called the minimally invasive procedure a less-damaging alternative to more radical open surgeries.
Given Imaging (Yokneam, Israel) said Empire Medicare Services issued a coverage policy for reimbursement of capsule endoscopy for the small intestine. Empire will offer capsule endoscopy reimbursement to its 5.4 million beneficiaries in the New York and New Jersey areas. Given Imaging produces the Given Diagnostic System, which features the M2A Capsule Endoscope, a disposable miniature video camera contained in a capsule that is ingested by a patient to deliver color images in a painless and noninvasive manner.
Gyrus Group (Reading, UK) has received 510(k) clearance from the FDA for use of its Gyrus ENT Somnoplasty System for tonsil reduction. The minimally invasive technology uses temperature controlled radio frequency energy to reduce obstructive symptoms of tonsillar hypertrophy (tonsil enlargement). The approval provides for treatment of tonsil enlargement, a common cause of upper airway obstructions in adolescents and adults. The Somnoplasty procedure takes 30 to 45 minutes and is performed under local anesthesia, usually in an outpatient setting. The device consists of a single-patient-use probe, which delivers specific amounts of radio frequency energy to the target tissue at relatively low temperatures (up to 85 C), creating finely controlled lesions beneath the surface of the tissue. As the tissue heals it shrinks, reducing the size of the tonsil, while leaving the surface intact and reducing postoperative discomfort, the company said. Somnoplasty has been cleared by the FDA for use in the treatment of obstructive sleep apnea, chronic nasal obstruction and habitual snoring.
Hypertension Diagnostics (St. Paul, Minnesota) introduced at the International Society of Hypertension and the European Meeting on Hypertension in Prague, Czech Republic, its international physician office product, the CVProfilor MD-3000 System. The system is CE-marked and is designed for use in physicians' offices outside the U.S. to noninvasively assess the health of patients' large and small arteries for the early detection and management of vascular disease. The CVProfilor MD-3000 System allows physicians to detect a premature loss of arterial elasticity in the microvasculature, providing new clinical information on the cardiovascular health of patients, expanding vascular disease assessment to include teens and young adults, monitoring the effects that cardiovascular drugs have on vascular elasticity, and establishing a baseline for vascular disease risk.
Medical Services International (Edmonton, Alberta) began shipping its VScan Rapid Test Kits for Tuberculosis (TB) to various countries for independent verification of its own test results. The original results demonstrated that the VScan TB Test Kit has a sensitivity of 80% and specificity of 100%. Sensitivity is defined as the repetition of a positive result in individuals with the disease in question. Specificity is defined as the repetition of a negative result in individuals without the disease. The only test kit currently available has a sensitivity of 60%. Use of VScan does not require medical or skilled personnel and produces visible results in less than 20 minutes.
Medtox Scientific (St. Paul, Minnesota) was granted U.S. patent No. 6,376,251 for its on-site drug testing method, to test analytes such as urine to determine whether the analyte contains specific substances such as drugs of abuse. The on-site screening test provides a preliminary test result either by visual or machine analysis of a screening test device, and the result and user data are entered on a provided form. An electronic image or the form is sent to a central location, where it is received and stored. If the test provides a positive result, a sample is sent to a lab for further testing, but if the test provides negative results, no further testing is done.
Neoprobe (Dublin, Ohio) reported at the International Conference on Xenon CT-CBF and Related CBF Techniques in Hannover, Germany, clinical results for Quantix/ND, a blood flow measurement device developed by its wholly owned subsidiary Cardiosonix Ltd. (Hod Hasharon, Israel). The evaluations in the acutely injured patients compared the measurement of internal carotid artery blood flow with the Quantix/ND to CBF measured using Xenon gas and variances in blood oxygen content. Data showed that blood flow volume measurements with the Quantix/ND could be performed and implemented in a critical care bedside setting. Both studies suggested that the Quantix/ND was promising for monitoring critically ill neurological and neurosurgical patients. Cardiosonix is planning the commercial launch of the Quantix/ND later this year in both the U.S and Europe.
North American Scientific (Chatsworth, California) said its Theseus Imaging division presented data on annexin imaging at the Society of Nuclear Medicine meeting in Los Angeles, California. Recombinant human annexin is the targeting component of Theseus' Apomate imaging agent, being developed for the noninvasive assessment of early response to anti-cancer treatment and for evaluation of myocardial damage in acute myocardial infarction and cardiac transplant rejection. Data showed that Tc-99m annexin myocardial images performed within 96 hours of onset of acute symptoms may be used to detect acute MI, and that increased myocardial uptake of tracer tended to persist for about three weeks and then decrease over the subsequent two to four months. Another trial confirmed that Tc-99m annexin could detect apoptotic cells within 30 minutes after acute myocardial ischemia and reperfusion. A number of papers addressed the potential utility of Tc-99m annexin in the evaluation and identification of atherosclerotic plaque.
Regeneration Technologies (RTI; Alachua, Florida) introduced the next-generation BioCleanse tissue sterilization system, which sterilizes tissue from a single donor in one of several individual processing units, eliminating the need to batch tissue from multiple donors during the sterilization process. Tissue from a single donor is sterilized separately with no commingling of tissue or fluids at any time during the process, which will be phased in over the next two months. The BioCleanse system is a low-temperature chemical sterilization process that eliminates bacteria, fungi and spores, as well as enveloped and non-enveloped viruses such as HIV and hepatitis from tissue, without altering the strength or biocompatibility of the allograft. RTI, which plans to make the process commercially available, has distributed more than 200,000 allografts sterilized by the BioCleanse system since March 2000 with no incidence of infection.
Smith & Nephew (S&N; Memphis, Tennessee) introduced the first variations on its Oxinium metal femoral components for total knee arthroplasty. The femorals, made out of the orthopedic division's exclusive oxidized zirconium material, are now available in a posterior-stabilized option within the Genesis II total knee system and in a macrotextured option within the Profix total knee system. The company said the posterior-stabilized Genesis II Oxinium femoral component offers minimal bone resection and simple, one-additional-step instruments. It also features an optimized patella groove that is longer than most posterior-stabilized designs, allowing for better patellar tracking. The Profix Oxinium macrotextured femoral component features a roughened, 3-D contour to the fixation surface of the implant. A proprietary chemical photo-etching process creates a controlled and reproducible surface that has been engineered for optimum fixation. This surface is not a coating but an integral part of the base metal, S&N said. The Oxinium components are being released on a limited basis, but will be more widely available by year-end. Smith & Nephew said it plans to introduce a macrotextured Oxinium component for the Genesis II total knee system later this fall.
SpectRx (Norcross, Georgia) released at the American Diabetes Association (Alexandria, Virginia) meeting in San Francisco, California, its SimpleChoice easy disposable infusion set. SimpleChoice is an alternative insulin pump disposable infusion set cleared for use with three major makes and brands of insulin pumps. The SimpleChoice easy includes the FeatherEdge introducer needle and SoftWear cannula for insertion comfort, SlimLine contoured hub designed for discreet wearing, SmartTubing delivery system engineered to reduce kinking and bulkiness, SureClick connection system for stable connect and disconnect at the site. SpectRx said it has additional insulin delivery products under development.
Symphonix Devices (San Jose, California) reported the findings of a recently concluded study showing that the Vibrant Soundbridge middle earn hearing device is safe and effective long after initial activation. The study showed that Vibrant Soundbridge patients achieved more functional gain in hearing — by more than 10 to 15 decibels — than they did with the use of conventional acoustic hearing aids. In the study, researchers followed the first 100 U.S. patients implanted with the Vibrant Soundbridge since 1997.
Varian Medical Systems (Palo Alto, California) received FDA 510(k) clearance to market a rapid, updated version of its inverse treatment planning software for SmartBeam IMRT. Helios 6.5 runs on the company's Eclipse platform, designed to expedite and improve radiation treatment planning in a Windows environment. Helios 6.5 is an inverse treatment planning tool that calculates an optimal way of filling a radiation oncologist's prescription specifying the radiation dose levels for a tumor and dose constraints for the surrounding healthy tissues. It automates a number of complex functions that help doctors work with 3-D images to create prescriptions for radiation treatment.
Ventana Medical Systems (Tucson, Arizona) said it is developing a diagnostic kit for use with the Novartis (Basel, Switzerland) drug Gleevec, the first signal transduction inhibitor approved for marketing in the U.S. Gleevec was first approved by the FDA last year for use with chronic myeloid leukemia patients, and the drug's labeling was extended in February for treatment of patients with c-kit positive inoperable and/or metastatic malignant gastrointestinal stromal tumors. Ventana is collaborating with Novartis to develop a diagnostic kit for c-kit and file a premarketing approval application for the diagnostic. C-kit will be the second targeted diagnostic kit developed by Ventana, which already markets the Pathway Her-2/neu diagnostic kit.
Viasys Healthcare's (Conshohocken, Pennsylvania) Medical Data Electronics subsidiary (MDE; Arleta, California) released a single-patient-use Angel Telemetry set. Angel is an all-in-one telemetry set designed with integrated lead wires, electrodes and a battery that provides cardiac monitoring in excess of 72 hours. The complete unit weighs 2.8 ounces. No cleaning is required, eliminating concern about infection. Angel operates in the WMTS 608-614MHz medical band, providing a solution for hospitals needing to upgrade their telemetry units to the newly mandated frequency band. MDE makes wireless patient monitoring systems for neonatal, pediatric and adult patient care.
WorldHeart (Ottawa, Ontario) submitted to the FDA a premarket application supplement for use of an expanded polytetrafluoroethylene (ePTFE) inflow conduit as an alternative option for its Novacor left ventricular assist system (LVAS). The inflow conduit carries blood from the natural heart to the Novacor LVAS, which then pumps the blood into the aorta to assist a failing heart. The conduit, which uses (ePTFE) graft material, was approved in the European Union. WorldHeart said the ePTFE conduit has undergone several design refinements, which have yielded additional structural strength. WorldHeart earlier said it would submit to the FDA in 3Q02 a PMA supplement seeking destination therapy indication for its Novacor LVAS. The Novacor LVAS is an electromagnetically driven pump that provides circulatory support by taking over part or all of the workload of the left ventricle.