Novametrix Medical Systems (Wallingford, Connecticut) said it has received FDA marketing approval for its MARSpO2 Tech pulse oximeter. The MARS (Motion Artifact Rejection System) is a high-performance pulse oximeter which improves pulse oximetry performance on patients who experience significant motion or have poor blood flow.
William Lacourciere, chairman, president, and CEO, said that MARS "is a technical advance ... which provides accurate oxygen saturation and pulse rate information, even in a highly agitated and/or under-perfused patient."
Novametrix makes electronic medical instruments and sensors to noninvasively and continuously provide cardiac output, oxygen, carbon dioxide, and respiratory mechanics measurements.
Elsewhere in the product pipeline:
Advanced Magnetics (Cambridge, Massachusetts) said the FDA has accepted the filing of the company's new drug application (NDA) for the Combidex magnetic resonance imaging contrast agent. Based on the priority review status assigned to Combidex by the FDA earlier, the NDA review is scheduled to be completed by June 19, 2000. The FDA has notified the company that it is contemplating taking the Combidex NDA to the Medical Imaging Advisory Committee in May. The Combidex NDA covers two indications. The principal requested indication is for the diagnosis of lymph node disease to assist in directing biopsy and surgery as well as to aid in the staging of metastatic lymph node involvement for a variety of cancers, including breast and prostate cancer. The second is for the detection, diagnosis, and characterization of benign vs. malignant lesions of the liver and spleen.
Advanced Tissue Sciences (La Jolla, California) and its marketing partner, Smith & Nephew plc (London), said the FDA approved an application for an amendment to the investigational device exemption for the clinical trial of Dermagraft to treat diabetic foot ulcers. The companies sought the amendment to revise the enrollment criteria and the statistical plan for data analysis based on data presented in December.
Agilent Technologies (Palo Alto, California) has introduced the Agilent 1100 Series LC/MSD Trap, a high-performance liquid chromatograph/mass spectrometer (LC/MS) ion-trap system that provides liquid chromatographers and mass spectrometrists with the data to solve research questions. In qualitative analyses, the ion trap generates multiple stages of MS needed to unambiguously characterize compounds and elucidate structures. For quantitative applications, MS/MS provides greater specificity and sensitivity for fast, accurate quantitation, even when chromatographic peaks are not completely resolved and sample matrices are complex. Agilent's LC/MSD vacuum system, inlet system, and orthogonal-spray API ion source are combined with Bruker Daltonics' multi-pole ion-trap design for improved LC/MS/MS and CE/MS/MS performance in a benchtop package.
Biopure (Cambridge, Massachusetts) reported that a new study has shown that its investigational oxygen therapeutic, Hemopure (hemoglobin glutamer-250 [bovine]), restores and sustains brain oxygenation, blood pressure, and cardiac output following severe hemorrhagic shock. Final results of a preclinical pharmacology study were presented at the 30th annual scientific meeting of the Western Trauma Association in Lake Tahoe, California. The study was conducted in an animal model designed to simulate what happens to humans after an accident. Researchers evaluated the effect of Hemopure on brain oxygen tension (a measure of brain oxygenation), mean arterial pressure, and cardiac output in hemorrhaged swine that had lost an estimated 42% of their total blood volume. The final study results reaffirm preliminary results, according to the company.
Bio-Vascular (St. Paul, Minnesota) has received FDA 510(k) marketing and CE Mark registration in the European Union for the use of Peri-Strips and Peri-Strips Dry to reinforce the gastric staple line in the bariatric surgical procedures of gastric bypass and gastric banding. Peri-Strips products are composed of two strips of biological tissue and are manufactured using a proprietary and patented technology that maintains the integrity of the collagen fibers in the tissue, allowing it to mimic the patient's own tissue. Gastric bypass involves connecting a small pouch of the stomach directly to the small intestine. An estimated 25,000 of these procedures are performed annually in the U.S.
Caliper Technologies (Mountain View, California) has received a U.S. patent covering microfluidic chip technology, titled "Apparatus and Method for Performing Manipulations for Chemical Analysis and Synthesis," licensed to the Department of Energy's Oak Ridge National Laboratory. This patent joins four other issued patents on technology developed by Dr. J. Michael Ramsey of Oak Ridge that, together, establish broad coverage for precisely controlling the flow of materials in microfluidic networks. Caliper holds an exclusive commercial license in a broadly defined field to all of these patents from Oak Ridge, subject to government use rights. The new patent contains 112 claims for microfluidic devices or chips that achieve precise manipulation of materials within microfluidic channel networks in applications such as genetic analysis, DNA sequencing, and SNP genotyping, pharmaceutical drug screening, and clinical diagnostics.
Surgical robotics developer Computer Motion (Santa Barbara, California) has been issued two new patents. In particular, U.S. Patent No. 6,001,108 gives Computer Motion ownership of the concept of using robotic arms to perform coronary suturing. Together, the new patents bring the total patents held by the company to 21, with 50 pending.
Data Critical (Redmond, Washington) said it has added the FlexView Clinical Network system to its line of patient monitoring communication solutions. FDA-approved, the FlexView system enables hospitals to integrate and track various stand-alone patient care devices from different manufacturers into one central monitoring system. The system can link up to 10 devices per patient for as many as 40 patients. The system will initially support the monitoring of pulse oximetry and infusion pump devices through a dedicated wiring network at distances of up to 300 feet from the nurses' central station. The FlexView system is an extension of Data Critical's AlarmView family of products.
Digene (Gaithersburg, Maryland), said preliminary results indicate that Digene HPV Test was 96% sensitive in detecting cervical disease in women with Ascus Pap smear diagnoses, while the expert Pap smear used in the trial was 85% sensitive. The HPV Test also was slightly more specific than the Pap smear.
FibroGen Europe (Oulu, Finland) has been granted a European patent for synthesizing, generating, and enhancing recombinant collagen products. Similar patents have been granted to the company in the U.S. and in Australia, it said. FibroGen Europe is developing human recombinant collagen and gelatin products with multiple applications in medical device and pharmaceutical product markets and is currently producing pilot scale batches of the material for evaluation by medical device and pharmaceutical manufacturers.
Genzyme Tissue Repair (Cambridge, Massachusetts) said orthopedic surgeons found that 85% of patients treated with Carticel autologous cultured chondrocytes to repair damaged cartilage on the thighbone part of the knee showed improvement four years after therapy. Carticel, approved in August 1997, is indicated for the repair of damaged cartilage on the thighbone part of the knee caused by acute or repetitive trauma in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. The report, with data collected on 47 patients, was scored according to clinician and patient evaluations of overall knee condition, patient reports of symptoms, such as pain and swelling, and knee examination results.
Imaging Diagnostic Systems (Fort Lauderdale, Florida) has received approval to conduct clinical studies of its diagnostic breast imaging system (CTLM) with indocyanine green contrast agent (ICG). The study will investigate the use of fluorescent compounds, such as ICG, to determine if it increases the imaging sensitivity of the CTLM by enhancing the presence of a suspicious lesion. Additionally, the company has received a U.S. patent titled "Device for Determining the Perimeter of the Surface of an Object Being Scanned and for Limiting Reflection From the Object Surface," covering the technique for determining the perimeter of the breast, which simplifies the algorithms necessary to produce the image.
IntraTherapeutics (St. Paul, Minnesota) reported the first implant of its IntraStent DoubleStrut Extra Support (XS) renal stent, the procedure was done by Gary Ansel, MD, at Grant/Riverside Methodist Hospital (Columbus, Ohio) under an investigational device exemption. The study is analyzing the stent's use in severe renovascular hypertension due to renal artery stenosis. About 30 medical centers in the U.S. will participate in the trial.
Iridex (Mountain View, California) said it has begun enrollments for a 20-center clinical trial which could validate a therapy for the majority of patients with wet, age-related macular degeneration (AMD), a disease that damages the central vision and is the leading cause of blindness in the western world. The study, titled "Transpupillary Thermotherapy (TTT) Of Occult Subfoveal Choroidal Neovascular Membranes (CNV) In Patients With Age-Related Macular Degeneration (TTT4CNV)," will use a low dose of infrared laser light, without adjunctive therapeutic drugs, for the treatment of eyes with occult wet AMD. The laser used for the study is the company's IRIS Medical OcuLight SLx infrared laser photocoagulator.
Micro Medical Systems (MMS; Sioux Falls, South Dakota) reported that its National Cardiac Surgery Registry software package, STS Access, has been certified by the Society of Thoracic Surgeons and also now incorporates the algorithms for risk stratification. STS Access provides surgeons and hospitals with comparative outcomes and statistical reports and allows them to use the data to compare themselves to others on a local, regional, or national level. This is the second fully certified registry submission software package from MMS. ACC Access, a National Cardiovascular Data Registry database, was certified by the American College of Cardiology in March 1998.
MiniMed (Sylmar, California) has received the CE Mark for its next-generation implantable insulin pump, made for MiniMed by Medical Research Group (MRG). The pump features improved memory and a longer battery life, and is lighter in weight than the predecessor pump. The company said that European sales, to be initiated in the next quarter, are expected to be limited until the specially formulated implantable pump insulin, manufactured by Aventis, is approved for commercial use. The new system has been designed to enable it to be joined with a long-term sensor being developed by MRG, thus creating an implantable artificial pancreas.
NeoRx (Norcross, Georgia) has reported excellent safety in the Phase II study of its Skeletal Targeted Radiotherapy (STR) against multiple myeloma, a fatal cancer arising in the bone. "The excellent safety profile observed in the Phase I dose escalation part of the study has been confirmed in these Phase II patients treated at the highest dose with which we expect to conduct the pivotal trial," said Paul Abrams, MD, NeoRx CEO. Fourteen patients received 40 Gray (4,000 rads) of radiation, nearly four times the highest dose generally administered with conventional external beam radiation therapy, in addition to standard high-dose chemotherapy. No toxicity above Grade II in organs other than bone marrow was encountered in the 13 Phase II patients treated last year; the 14th was treated more recently and awaits evaluation, according to the company.
ReGen Biologics (Franklin Lakes, New Jersey) has been granted CE marking for its Collagen Meniscus Implant (CMI) and will launch the product in Europe through its distribution partnership with Sulzer Medica (Winterthur, Switzerland). manufacturers. CMI is used in treating tears of the meniscus of the knee which, when damaged, can lead to degenerative osteoarthritis. The device is a resorbable collagen scaffold designed to prevent or delay degenerative changes after a partial meniscectomy. ReGen is conducting multi-center clinical trials of the CMI in the U.S.
STS Biopolymer (Henrietta, New York) has launched its Echo-coat Ultrasound Needle with 2-D and 3-D imaging, featuring new ultrasound reflective coating. The needles feature a biocompatible polymer coating which traps micro-bubbles of air to provide an increased scattering cross section to the surface of the implanted device. The entire needle can thus be seen under all conditions with no variation in echogenicity up to an angle of 90 degrees from the transducer in all modes and in different types of tissue. This addresses the problem of poor visualization of biopsy needles in abdominal procedures due to acoustic angle dependence.
SurgiLight (Orlando, Florida) has submitted an investigational device exemption application to the FDA for laser presbyopia reversal using its patent-pending technology and expects to obtain institutional review board approval from Mt. Sinai Hospital (New York) to begin the clinical trial soon. The IDE submission includes the results of 19 cases of laser presbyopia correction to support the application for an additional 30 cases. The reported data shows more than six months follow-up for patients 42 to 65 years of age with little or no regressions. Details of the first group of clinical results were reported by the company at the 1999 World Refractive Surgery Symposium.
Thoratec Laboratories (Pleasanton, California) reported that J. Donald Hill, MD, a cardiac surgeon at California Pacific Medical Center (San Francisco, California), has performed minimally-invasive implantation of the Thoratec VAD (ventricular assist device) in two patients who were later transplanted. The company believes this is the first time that a VAD has been implanted in a minimally invasive way, that is, without a sternotomy, thus making the transplant surgeries less risky and less complicated. "It reduces scar tissue around the heart that can occur following routine cardiac operations and allows for much easier removal of the device and placement of the new heart at the time of heart transplantation," Hill said.
UroMed (Norwood, Massachusetts) has received FDA marketing clearance for its CaverMap Surgical Aid used in colorectal surgery in men. The CaverMap Surgical Aid is currently used to assist surgeons in performing prostate cancer surgery in identifying and sparing sensitive nerves responsible for erectile function. The CaverMap Surgical Aid is designed to help colorectal cancer surgeons identify the location of sensitive nerve bundles during colorectal surgery to help preserve sexual function.
Uroplasty (Minneapolis, Minnesota) and its European subsidiaries have received the CE Mark for a new set of instruments for the non-endoscopic delivery of macroplastique, named the Macroplastique Implantation System (MIS). Additionally, Uroplasty said it has obtained approval to market and sell the MIS in Canada. The MIS system is designed for use to deliver macroplastique implants for the minimally invasive treatment of female stress urinary incontinence and provides for implantation of the company's soft tissue bulking material into the wall of the urethra without the use of an endoscope.
Valley Forge Scientific (Oaks, Pennsylvania), a developer of electrosurgical products, has released its new line of disposable neurosurgical instruments for distribution worldwide. The instruments will be distributed by the Codman & Shurtleff subsidiary of Johnson & Johnson and are designed to be used with Valley Forge's Malis bipolar electrosurgical generators, sold by Codman & Shurtleff in more than 50 countries under a distribution agreement with Valley Forge.