An FDA advisory panel last month recommended that the agency send to market a computer-aided detection (CAD) device that can help radiologists find extremely small and overlooked cancers on chest X-rays. Voting on the RapidScreen TM RS-2000 System manufactured by Deus Technologies (Rockville, Maryland), the panel unanimously recommended approval, but with stringent strings attached. Most importantly, the panelists want stronger label warnings about device limitations.
"All the warnings were in the premarket application," panel chairman Brian Garra, MD, of the University of Vermont (Burlington, Vermont) told BBI, "but the panelists were concerned because most people don't read all the labeling. Panelists want them emphasized."
The 5-0 vote followed the Deus presentation, an FDA analysis of the premarket approval application (for a revised indication for use) and discussion led by Alicia Toledano, ScD, an assistant professor of biostatistics at the University of Chicago (Chicago, Illinois).
Deus prefers marketing the RapidScreen machine as an adjunct application in which the Rapid Screen system performs a computer analysis and identifies regions of interest on a chest X-ray after an initial reading of the film. Thus the device is designed to assist the physician "in identifying areas containing a potential lesion that previously may have been missed," Deus said.
Some panelists were less enthusiastic during the discussions. Wendie Berg, MD, PhD, characterized the device as offering "marginal benefit" relative to spiral computed tomography (CT). Berg is director of breast imaging at the University of Maryland's (College Park, Maryland) department of radiology. Participants in the discussion had noted that a doctor using the device and seeing a suspicious nodule is likely to recommend a follow-up CT scan before a biopsy.
The RS-2000 looks like a photocopy machine with a computer screen tacked on. It detects lung nodules in chest radiographs by reading a digitized image and analyzing it using a patented process. The results are displayed, with suspicious areas being marked by the machine, on either a paper printout or a monitor. That process, according to Michael Yeh, PhD, president of Deus Technologies, uses heuristic decision rules, artificial neural networks and fuzzy logic to classify suspect areas. The analysis incorporates 87 proprietary cancer and non-cancer descriptive feature sets derived from clinical information, including size, shape, anatomic structures and information about cancer growth.
Data from a clinical study of the CAD device was presented by Matthew Freedman, MD, clinical director of Deus and also clinical director of imaging sciences and information systems at Georgetown University Medical Center (Washington).
The study compared 15 radiologists' ability to detect lung cancers of different sizes on chest radiographs with and without the CAD device. After CAD training, the radiologists examined 80 chest X-rays that contained cancers and 160 that did not. The data demonstrate, Freedman told the panel, that radiologists using the system will detect more cancer cases than those examining films independently. The main improvement is in lesions 9 mm to 15 mm in size, with moderate improvement in the detection rate for 15 mm to 19 mm lesions. The study found no significant improvement in performance with larger lesions. Radiologists using the system detect more lung cancers, detect more of the smaller cancers and detect cancers previously missed, he said.
In discussing the data, several panelists expressed concern that the clinical study examined only the chest X-rays of older male smokers. They also were concerned that there was an increased rate of false positives and false negatives, thus influencing an impressionable radiologist to incorrectly back off an unaided reading.
In the end, however, the panel voted that the FDA permit, with five conditions, marketing of the RapidScreen RS-2000 System as a computer-aided detection device that would serve to help physicians detect suspicious lung nodules on chest X-rays.
Panel Executive Secretary Robert Doyle, an electrical engineer who also is the FDA's lead reviewer on the PMA, created a summary for the agency immediately after the meeting.
The summary, he told BBI, emphasizes that the prescribed conditions "all apply to the labeling and are intended to ensure that users understand exactly what the device was shown capable of doing." The panel wants users to understand, in particular, that the device will mark chest X-rays with a "substantial number of false positives and false negatives."
AeroGen (Sunnyvale, California) said its AeroDose ipratropium inhaler, being developed for the treatment of respiratory disorders, entered Phase II trials. The inhaler is a small, portable hand-held device that uses AeroGen's proprietary aerosol generator technology to aerosolize liquids.
Arrow International (Reading, Pennsylvania) reported the first U.S. human implant of the company's fully implantable Left Ventricular Assist System, named the LionHeart, performed by Walter Pae Jr., MD, professor of surgery at Penn State Milton S. Hershey Medical Center (Hershey, Pennsylvania). The patient is recovering as expected, according to Arrow. LionHeart development has been an eight-year joint effort of Pennsylvania State University's medical school at Hershey Medical Center and Arrow, with early development funded by a U.S. National Institute of Health grant to the medical school's division of artificial organs. The implant was the first to be conducted by the company under an investigational device exemption. The LionHeart is capable of taking over the entire workload of the left ventricle, and it has no lines or cables protruding through the skin to power the system, thus eliminating a potential for infection. The device is electrically driven by a wearable battery pack that transmits power noninvasively through the skin to charge internal batteries and power the blood pump.
BICO (Pittsburgh, Pennsylvania) subsidiary Diasensor.com has launched DataCONN, an on-line telemedicine service for use by people with diabetes who monitor blood glucose levels using an invasive meter. Professional caregivers who make treatment decisions for their diabetic patients based on invasive meter readings can also use DataCONN. Using the Internet or a touch-tone phone, DataCONN gives subscribers a method to record glucose measurements in a secure, centralized database maintained by Diasensor.com. Both patients and their caregivers can access the information at the password-protected web site. The display and graphical analysis of the glucose measurements provide the patient and physician with improved visibility of glucose trends and patterns, and of the effectiveness of the patient's current therapy.
Biomerica (Newport Beach, California) said that the Japanese Ministry of Health has approved for distribution and marketing EZ-PSA, a 10-minute disposable screening test designed to detect prostate specific antigen (PSA), an early warning indicator of prostate cancer. The approval follows extensive clinical trials conducted on the product in Japan. The studies were conducted in collaboration with the Departments of Urology at Dokkyo University School of Medicine and Tokyo University, Diai Memorial Hospital, and the company's marketing partner. The product is a disposable test that doctors can use while the patient is in the office. The one-step test requires a single drop of whole blood from a finger prick. The blood is applied to the test device, which will indicate within 10 minutes whether the patient's level of PSA is elevated. Biomerica is a global medical technology company. The company's diagnostics division makes products used in the home, in hospitals and in physicians' offices for the early detection of medical conditions and diseases.
Cambridge Heart (Bedford, Massachusetts) said that the American Medical Association (AMA; Chicago, Illinois) has notified the company that it will establish a permanent Category I CPT code for Microvolt T-Wave Alternans testing. The decision to issue the Category I code supercedes the AMA's earlier decision to issue a temporary CPT III tracking code for the procedure. The AMA determined at its February committee meeting that a new Category I CPT code is appropriate for Microvolt T-Wave Alternans testing based on literature and data submitted by Cambridge Heart. The AMA found that the data demonstrate the test is predictive of sudden death. The new code is due for publication in January 2002.
Cardiac Science (Irvine, California) said it has been granted approval by the Canadian regulatory agency, Health Canada, to allow Cardiac Science to begin marketing its fully automatic Powerheart hospital bedside defibrillator-monitor in Canada. Cardiac Science makes external cardiac defibrillator devices and software that monitors a patient's cardiac activity, instantly detects the onset of a life-threatening heart rhythm and automatically delivers defibrillation without human intervention.
Chiron (Emeryville, California) and Gen-Probe (San Diego, California) said that the biologics license application (BLA) for the Chiron Procleix HIV-1/HCV Assay for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) has been accepted for review by the FDA. The application was previously designated for fast-track review, the company said. The assay is a nucleic acid amplification test (NAT) designed to detect the presence of HIV-1 and HCV in whole blood and plasma during the earliest stages of infection, when these infectious agents appear in the blood but cannot yet be detected by current serological screening technologies. Using transcription mediated amplification technology developed by Gen-Probe, the assay may significantly reduce the time between infection and detection. Industry data show that NAT can reduce the window period by as much as 85% in the case of HCV and 50% in the case of HIV-1.
Cook (Bloomington, Indiana) said it is the first company to receive FDA approval to evaluate a coronary stent coated with the anti-restenosis drug paclitaxel in U.S. patients. The company currently is conducting multicenter trials of paclitaxel-coated coronary stents in human patients in Europe and Asia. The paclitaxel-coated Logic Coronary Stent from Cook uses the drug paclitaxel to inhibit restenosis. The metal body of the stent is coated with a minute quantity of the drug, which is gradually released into the cells of the arterial wall. Paclitaxel acts to prevent excessive cell regrowth at the site of the angioplasty, which researchers hope will reduce or eliminate restenosis. The stent is indicated for use in patients with symptomatic ischemic heart disease, or with a positive cardiac stress test, due to de novo lesions in native coronary arteries with a reference vessel diameter in the range of 3.0 mm to 4.0 mm. It is an investigational device not yet approved for sale in the U.S.
Cholestech (Hayward, California) said the European Patent Office has granted a patent for the company's high-density lipoprotein (HDL) cholesterol assay for use on the Cholestech LDX system. The grant gives Cholestech patent rights in Austria, Belgium, Switzerland, Germany, France, Spain, Great Britain, Italy, Luxembourg and the Netherlands. The HDL cholesterol test measures the amount of "good" cholesterol in the blood of a patient. This test, when combined with the other tests in a lipid profile, helps determine the ratio of HDL to low-density lipoprotein (LDL) cholesterol, the so-called "bad" cholesterol. HDL/LDL ratios can be used to help determine an individual's risk of coronary heart disease. Cholestech says its system can conduct multiple simultaneous diagnostic tests from a single drop of blood and provide results, in less than five minutes, which are as accurate as similar tests performed in clinical and hospital labs.
C. R. Bard (Murray Hill, New Jersey) said it has received 510(k) approval from the FDA to market its next-generation Luminexx Self-Expanding Nitinol Biliary Stent for the treatment of malignant biliary obstructions. The stent will be marketed through Bard's Peripheral Technologies division. This stent combines the trackability and flexibility of the Memotherm Flexx biliary stent delivery system with the Luminexx stent's radiopaque marker technology. This technology greatly improves radiopacity, allowing for better stent visualization, pre- and post-placement says the company. Additionally, the company said it has received an investigational device exemption from the FDA and has begun a clinical trial to examine its new ePTFE-encapsulated self-expanding stent. Developed and manufactured at its IMPRA (Tempe, Arizona) subsidiary, the device is intended to be used for the treatment of venous anastomotic stenosis, a condition that occurs in many dialysis patients who have been treated with an arterio-venous shunt. This device will be evaluated as an alternative to balloon angioplasty or surgical revision in these patients. According to the U.S. Renal Data System Report, more than 250,000 patients in the U.S. are currently being treated with dialysis, and this patient pool is growing at a double-digit rate. In order to facilitate treatment, a significant number of these patients will have a synthetic vascular graft surgically implanted between the venous and arterial systems. The device to be clinically evaluated comprises a nitinol framework totally encapsulated in ePTFE, complete with a carbon luminal lining, similar to the IMPRA Carboflo line of vascular grafts. The delivery system used to deploy the device is a flexible 9 Fr retracting sheath system.
CryoLife (Kennesaw, Georgia) a maker of tissue-engineered implantable heart valves, vascular grafts and protein-based surgical adhesives, revealed the results of an eight-year follow-up study of patients who have undergone total or partial meniscus replacement knee reconstructive surgery. The results of the follow-up study (1991-2000) involving 13 implanting surgeons and 136 patients were presented at the Meniscus Transplantation Study Group, held in conjunction with last week's American Academy of Orthopaedic Surgeons meeting in San Francisco, California. Steven Anderson, president and CEO of the company noted, "The eight-year follow-up study was designed to substantiate the efficacy and validity of utilizing cryopreserved human meniscus cartilage in orthopaedic reconstructive surgery in restoring normal knee function for patients suffering from meniscus damage." The study results indicate that 90% of patients reported their surgery as a success, 80% rated their current knee function as normal to nearly normal, 86% of patients reported freedom from graft removal and 76% had good to excellent results at eight years. Pain levels were rated low at an average of 2.7 on a 10-point scale.
Digirad (San Diego, California), a developer of solid-state gamma cameras for use in nuclear medicine, reported being issued four patents over the past five months for its solid-state digital gamma cameras and solid-state radiation detectors. Digirad's first product, the 2020tc Imager, weighing 425 pounds, is the world's first commercially available solid-state digital gamma camera for nuclear medicine. Digirad now has 16 U.S. patents, 1 Japanese patent, and 10 more U.S. patents pending. The four new patents cover technologies used in an imaging system that includes at least a 3 x 3 array of multi-side buttable detection modules; a gamma ray detection device comprising a plurality of modules; a radiation imaging detection module wherein the detection module has at least one detection element and is buttable on all sides with adjacent detection modules; and a method of imaging a patient to whom a radionuclide has been administered comprising a detector that moves within a carrier and the carrier remains substantially immobile relative to the patient while readings are taken. Scott Huennekens, president and CEO of Digirad, said that these patent claims expand Digirad's broad patent protection for all-side buttable gamma ray detector modules, including those using scintillations crystals, and represent significant additions to the company's intellectual property portfolio.
Edwards Lifesciences (Irvine, California) reported FDA clearance of the Edwards Prima Plus Stentless Bioprosthesis. The Prima Plus porcine tissue valve is a next-generation treatment for surgeons who prefer a stentless alternative for replacement of a patient's diseased or malfunctioning aortic heart valve. Michael Mussallem, company chairman and CEO, said the valve "has the advantage of our proprietary XenoLogiX tissue treatment and offers a range of features designed to ease surgical implantation, which differentiate this valve from other stentless products." The Edwards Prima Plus is a biograft featuring a patented trim guide that aids the surgeon in tailoring the valve for sub-coronary implantation. Based on current clinical data, the company's stentless valve has demonstrated "excellent durability, with blood flow that is characteristic of stentless valves."
Encision (Boulder, Colorado) released a new design of its AEM electrosurgical cord, which the company said provides a functional safety improvement that no other company can provide. Electrosurgical "active" cords have historically been susceptible to conductor failures due to normal wear or from damage during normal handling in the operating room. This consequently can produce sparks at the breakage point due to the high-voltage power from the electrosurgical generator arcing across the open conductor break. Encision's AEM cord provides an improvement for what it termed "this industry-wide problem." While a conventional electrosurgical cord is simply a single active wire, the AEM cord is an active wire and two shield wires. A shield conductor failing before the active conductor will terminate the electrosurgical power and therefore provide a fail-safe condition, the company said.
Imatron (South San Francisco, California) discussed the results of a company study at the American Heart Association's conference on Cardiovascular Disease Epidemiology and Prevention held in San Antonio, Texas. Dr. Jerel Zoltick, from the Walter Reed Army Medical Center in Washington, performed a study which determined that the electron beam tomography (EBT) coronary artery scan (Imatron's proprietary scanning technology) clearly defined a subgroup of seemingly healthy patients at high-risk for coronary artery disease (CAD) that was not identified by standard CAD risk factors. The EBT coronary artery scan was able to identify people at high risk of a heart attack or other cardiovascular event even though they were fit, athletic, healthy, did not smoke and were free of diabetes, hypertension and high cholesterol. Zoltick's study group consisted of a large group of 436 asymptomatic senior military officers (400 males, 36 females) whose ages ranged from 33 to 56 years (mean age 43.5 +/- 3.2 years). In addition to receiving an EBT coronary artery scan, this relatively young study group also underwent extensive cardiovascular and fitness assessments, including exercise treadmill testing, a resting electrocardiogram, medical fitness and nutritional histories, blood lipid profiles and fasting blood sugar measurements.
Instrumentarium Imaging (Helsinki, Finland) recently introduced its mobile C-arm family Exposcop 8000 with the high-efficiency Active Cooling System, which is specially designed for long-term use in sterile surgical environments. The system is intended for long-term procedures such as vascular, cardiac, electrophysiological and endoscopic applications. The company said it is the only mobile system especially qualified for the implantation of latest-generation cardiac pacemakers, since it does not require any cool-down breaks or C-arm changes during the procedure. The system is completely integrated into the C-arm cover. The system functions automatically and needs no maintenance, the company said. Instrumentarium Imaging makes diagnostic X-ray imaging equipment, systems and solutions for surgical and interventional imaging, mammography and dental imaging.
The nation's first robotically assisted thoracic surgery using the da Vinci surgical system from Intuitive Surgical (Mountain View, California) was performed last month at Henrico Doctors' Hospital (Richmond, Virginia). The system was cleared for thoracic surgical procedures, and now allows cardiac surgeons to perform minimally invasive thoroscopic procedures. During the surgery by Dr. Marc Katz, the internal mammary artery (IMA) was harvested for use in a coronary bypass. Using the da Vinci system, three small ports were placed in the side of the patient's chest, each no more than 1 cm in diameter. Using an endoscope and two surgical instruments, the IMA was harvested for use in the surgery. "This is the first step toward our goal of total endoscopic, or closed-chest, coronary artery bypass surgery," Katz said. The da Vinci system already is being used in Europe to perform minimally invasive stopped-heart and beating-heart bypass surgery. Hospital stays are reduced to three days, as opposed to a week-length stay in an open-heart procedure.
LaserSight (Winter Park, Florida) has filed a PMA Supplement with the FDA requesting approval to use its LaserScan LSX excimer laser system to perform LASIK treatment of mixed astigmatism with the astigmatic component in the range of +0.5 diopters to +6.0 diopters. LaserSight now has five PMA supplements under active consideration by the FDA. LaserSight system uses a single treatment cross-cylinder technique, which is currently incorporated into the international version of its LaserScan LSX. The advantage, the company said, of cross-cylinder treatment for mixed astigmatism is that it conserves the cornea by selectively removing less corneal tissue than mixed astigmatism treatments with other laser systems that do not use this technique. Ablation profiles with the LSX are defined by the system software, and the ablation is performed under computer control through precision beam microspot scanning. In contrast, ablations for cross-cylinder corrections made with other laser systems may require the surgeon to manually calculate the treatment parameters and perform two separate treatments to achieve similar results.
LifePoint (Ontario, California) said that its flagship product, the LifePoint Test System, will be marketed under the name Impact. The Impact is a device used to rapidly detect alcohol and drug levels. It will be initially commercialized for law enforcement, as well as workplace and emergency medical testing to detect driver, employee and patient impairment.
MDX Medical (Vancouver, British Columbia) reported launch of patient testing of the company's acoustic emission (AE) technology as a result of a recently signed collaborative research agreement with the University of British Columbia (UBC) and Vancouver Hospital (VGH). Under the agreement, the groups will collaborate in a phased program of patient testing at VGH to determine the effectiveness of AE Technology in the diagnosis and monitoring of osteoporosis. The technology determines the correlation of signals emitted from the vertebrae, with the goal of providing a more accessible and cost effective earlier stage monitor of bone deterioration. MDX obtained worldwide commercialization rights to the patented AE technology through an exclusive license from UBC. Development of the AE testing system, including hardware and software for the initial patient testing, has been completed as a result of hardware development and system testing conducted at the company's lab facilities at the Jack Bell Research Center.
Medtronic (Minneapolis, Minnesota) reported commercial availability of a fixation device designed to help surgeons in effectively realigning and fusing vertebrae of the lumbar spine to treat degenerative disc disease. The LT-Cage Lumbar Tapered Fusion Device, cleared by the FDA last year, can be implanted laparoscopically or through an open incision to fuse spinal bones. This device helps restore height to collapsed discs and can help relieve painful pressure on nerves. It features a tapered design for a more natural fit than traditional cylindrical cages when fusing vertebrae. This natural fit helps maintain the natural curvature of the lower spine. The LT-Cage device also has been used in investigational clinical trials with Medtronic Sofamor Danek's InFuse Bone Graft (recombinant human bone morphogenetic protein). Michael DeMane, president of Medtronic Sofamor Danek, said, "The LT-Cage device will help surgeons continue to make spinal fusion procedures safer, more reliable and easier on the patient."
Medtronic Physio-Control (Redmond, Washington) has received FDA clearance for new features for the Lifepak 12 external defibrillator/monitor. The therapeutic and diagnostic Lifepak 12 product, used by trained emergency responders and medical personnel, will now offer two new trending capabilities as well as invasive pressure monitoring. The new monitoring capabilities, coupled with defibrillation therapy, will allow caregivers to carry a single device, instead of a separate defibrillator and a multi-parameter monitor during transport of critical care patients. The company says that trending of vital signs such as heart rate, respiration and blood pressure over time produces a record to aid in therapeutic decisions and in evaluating the patient's response to drug treatment. The system may be customized to the buyer's specifications, with choices of biphasic and monophasic fibrillation waveforms, automated and manual operation modes, and multiple options such as noninvasive pacing, pulse oximetry, 12-lead electrocardiography, capnography and noninvasive pressure monitoring. Medtronic Physio-Control is a unit of Medtronic (Minneapolis, Minnesota).
Meridian Medical Technologies (Columbia, Maryland) reported that a new clinical study published in the European Heart Journal demonstrates the superiority of its Prime ECG electrocardiac mapping system in the early diagnosis of acute myocardial infarction in high-risk patients whose symptoms are hard to interpret with a traditional 12-lead ECG. "The value of the Prime ECG in the correct diagnosis of the cardiac condition and in the risk stratification of these patients is of paramount importance," according to an accompanying editorial by Professor Preda of Semmelweis University (Budapest, Hungary). In the study, conducted by Dr. Ian Menown and colleagues at the Royal Victoria Hospital and the University of Ulster in Northern Ireland, 54 patients with chest pain and ST depression were evaluated with a standard 12-lead ECG system as well as the Prime ECG system, which uses 80 leads placed around the patient's torso. The standard ECG evaluation correctly identified only 38% to 50% of heart attacks in these patients, while the Prime ECG detected nearly 90% of heart attacks within minutes. The Prime ECG system features 80 leads incorporated in an easy-to-apply disposable electrode vest with an increased diagnostic detection area to obtain a more complete view of the heart's electrical activity.
Neoprobe (Dublin, Ohio) said researchers at the University of California, San Diego, received clearance from the FDA to begin clinical evaluation of a radiolabeled agent designed to assist in the diagnosis and surgical management of breast cancer patients. Patient enrollment for the trial will begin shortly, the company said. Neoprobe has an option agreement to exclusively license the agent for diagnostic use.
Ortec International (New York) filed a premarket approval application with the FDA requesting to market its composite cultured skin for the treatment of split thickness donor sites in burn patients. Ortec received FDA approval under a humanitarian device exemption for hand reconstruction and donor sites created in this procedure for victims of epidermolysis bullosa.
Orthovita (Malvern, Pennsylvania) said it has received regulatory approval to sell its Vitoss Synthetic Cancellous Bone Void Filler product in Australia. In conjunction with the clearance, Orthovita has named Advanced Surgical Technologies as its distributor for Australia and New Zealand. Vitoss is a resorbable calcium phosphate scaffold that, like human cancellous bone, is highly porous and composed of extremely fine calcium phosphate mineral that allows for resorption, cell seeding and ingrowth of host bone. Orthovita is a biomaterial company that makes products for use in surgical procedures in spine and osteoporotic fractures.
PARE Surgical (Englewood, California) reported receiving FDA clearance to market its PARE Flexible Endoscopic Suturing System which allows the gastroenterological surgeon to suture soft tissue when doing gastroenterological procedures by passing the suturing device through the operating channel of a flexible endoscope. The 2.8 mm gastroplication device passes suture, releases and secures a pre-tied Roeder knot and then cuts the suture free after approximating tissue or ligating vessels. The device allows, for the first time, suturing soft tissue of the stomach, esophagus and colon with a single insertion of the flexible endoscope, the company said. During treatment for GERD, the device can be used to place two small stitches near the lower esophageal sphincter and approximate the tissue to tighten the valve. Stomach contents are then prevented from flowing back up into the esophagus. The procedure can be preformed on an outpatient basis without general anesthesia.
PhotoMedex (Radnor, Pennsylvania) reported receiving FDA approval to market the Xtrac laser system for treating vitiligo, a disease that results in white spots due to the loss of pigmetation. Xtrac is the first FDA-approved excimer laser system approved for this treating this problem which affects an estimated 2 million to 4 million Americans. And it is the first FDA-approved laser treatment for psoriasis, the second most common skin disorder in the U.S. The spots occur when pigment cells, or melanocytes, are destroyed and the pigment melanin can no longer be produced. The company said it believes that, based on clinical trials, the system can re-pigment a patient's skin. Company President and CEO Jeff O'Donnell said that the approval expands the capabilities of the system and is "a testament to our belief in its potential effectiveness in the treatment of other skin diseases. This FDA approval will enable our doctors to offer an efficacious treatment to a patient population that, up to now, has had few options and is largely under-served."
Physiometrix (Billerica, Massachusetts), developer of the Patient State Analyzer (PSA 4000) anesthesia-monitoring system, reported receiving CE-Mark Approval for the PSA 4000 and ISO 9001 Certification for Physiometrix's manufacturing facility. The CE-Mark Accreditation and ISO 9001 Certification comes less than nine months after FDA approval of the PSA 4000. Designed for use by anesthesiologists, PSA 4000 is an early-warning device that enables an anesthesiologist to monitor and manage a patient's level of consciousness during surgery.
Additionally, the company discussed results of a clinical study with the PSA 4000 during cardiac surgery. The clinical study was conducted at the German Heart Institute (Berlin, Germany). Drs. A. Mappes, Dr. M. Gruendel and Dr. H. Kuppe concluded that even "in the stressful surrounding of a cardiac theater, it [the PSA 4000] represents a promising monitor for depth of sedation.""Physiometrix makes medical products – based on gel materials, signal processing electronics technologies and proprietary software – for use in anesthesia-monitoring applications during surgical procedures.
PLC Systems (Franklin, Massachusetts), a maker of transmyocardial revascularization (TMR) products, said it had received CE mark approval for its next-generation CO2 Heart Laser 2. The company received FDA approval in January to market the system. Building on the clinical performance of PLC's first-generation TMR laser, the next-generation system has greater mobility due to its smaller size, said the company. The CO2 TMR therapy is a surgical procedure that is designed to improve blood flow to the myocardium of the left ventricle of the heart, which relieves chest pain in severely debilitated heart patients. A cardiac surgeon uses the laser to create approximately 20 to 40 channels to allow oxygen-rich blood to reach previously deprived areas of the patient's heart.
A new urethral bulking agent developed by Protein Polymer Technologies (PPTI; San Diego, California) to treat female stress urinary incontinence is in clinical testing at three U.S. facilities. PPTI's agent has been designed to address the shortcomings in biocompatibility, ease of use and durability associated with other existing treatments. After injection, the product transforms from a liquid to a hydrogel, forming a solid implant and, as a result, is expected to enable patients to remain dry longer than patients treated with other product formulations.
Quest Diagnostics (Teterboro, New Jersey), the largest U.S. provider of diagnostic testing, and ProDuct Health, a developer of medical devices to fight breast cancer, said that Quest is the first commercial reference laboratory to accept ductal lavage specimens for analysis. Ductal lavage is a procedure for collecting precancerous and cancerous cells from milk ducts in the breast, the source of most breast cancer. By collecting cells directly from the milk ducts, the minimally invasive procedure functions somewhat like a Pap smear for the breast, allowing the early detection of premalignant and malignant cells from their source of origin. That gives physicians and their patients additional information to make decisions about management and therapeutic options. The devices used in the procedure have been cleared by the FDA for medical use. The procedure will be used as a way to assess risk among a group of women who are already at high risk for breast cancer. Cytopathologists at Quest have been trained on the clinical interpretation of breast ductal fluid samples obtained using ProDuct's InDuct Breast MicroCatheter and InDuct Breast Aspirator.
Specialized Health Products International (SHPI; Bountiful, Utah), a maker of medical safety needles, has received a new patent for medical needle retraction safety devices. This new technology has specific application to winged needle infusion and blood collection sets. The safety device is now being prepared for the market, molded parts have been obtained and customer focus groups have been conducted. SHPI said it now has 17 different and unique safety needle technologies. These technologies apply to almost all medical needles used today including: syringe, prefilled syringe, IV catheter, introducer, winged needle set, blood collection, procedure, Huber, specialty, and lancets. SHPI makes health care products that minimize the risk of accidental needlesticks
Sulzer Medica (Winterthur, Switzerland) said its subsidiary, Sulzer IntraTherapeutics, a maker of medical devices used in the treatment of peripheral vascular disease and non-vascular obstructions, launched the Protege self-expanding nitinol biliary stent in the U.S. Protege is designed to be the first self-expanding stent that does not shorten during placement. It features the StarPort Delivery Technology, which enables enhanced visualization during stent placement. The stent uses StarPort Delivery technology that features the ability to inject contrast media through the body of the catheter for enhanced visualization during stent placement. It also features varying flexibility along the length of the catheter to navigate through tortuous anatomy. The Protege is available in a variety of stent lengths and diameters. The stent will soon receive the European CE mark for peripheral vascular and biliary indications.
SurgiLight (Orlando, Florida) said it will begin Phase I clinical studies using its IR-3000 laser for laser presbyopia reversal in Spain. The company has received institutional review board approval at the department of ophthalmology, Institute Universitari Dexus, where Carlos Verges, MD, will perform the Phase I clinical study on a total of 10 eyes. The Phase I study follows the initiation of the baseline studies and research at the University of Utah Health and Sciences Center (Salt Lake City, Utah). The IR-3000 system is not FDA-approved for presbyopia. SurgiLight has other IR systems that are in U.S. clinical trials for glaucoma and cataract treatments.
TeraRecon (San Mateo, California) launched its Aquarius Workstation at the European Congress of Radiology exhibition in Vienna, Austria. The Aquarius product line features TeraRecon's 3-D and 4-D visualization and post-processing solutions for medical imaging devices such as computed tomography, electron-beam tomography and magnetic resonance scanners. In addition, the company's technology will be deployed to provide Intranet and Internet-based solutions for the distribution and review of medical images and reports. Aquarius will also be marketed to medical imaging OEMs for whom TeraRecon makes products for imaging applications from acquisition to review, distribution and archiving.
Trinity Biotech plc (Dublin, Ireland) said that the FDA has granted an investigational device exemption (IDE) for its Uni-Gold HIV Test. The IDE allows the test to be used in a number of hospitals throughout the country to provide patients with the results of tests conducted during ongoing clinical trials. Trinity's product will be used to provide diagnostic test results in less than 15 minutes in situations involving needle-stick injuries and pregnant women at high risk of HIV presenting for delivery. In these circumstances, the ability to diagnose HIV status rapidly provides the opportunity to make crucial medical decisions and to administer appropriate medication. FDA-approved HIV tests currently on the U.S. market may require up to 24 hours before HIV status can be determined. Clinical data gathered during these trials will be submitted to the FDA as a supplement to the data already provided by Trinity Biotech in its premarket approval application. Trinity makes more than 200 diagnostic products for the point-of-care, self-testing and clinical laboratory segments of the diagnostic market.
Varian (Palo Alto, California) introduced a new component for its nuclear magnetic resonance (NMR) instruments, a cryogenic NMR probe. The cryogenic NMR probes, which cost up to $200,000, will be available for new Varian spectrometers and for boosting the sensitivity and productivity of the company's worldwide installed base of some 2,500 instruments.
Vasogen (Toronto, Ontario) said it received approval from Health Canada to proceed with a multi-center trial of its immune modulation therapy for treatment of moderate to severe psoriasis. The 105-patient trial at four sites is designed to study the impact of optimized dosing schedules and further evaluate efficacy. Vasogen said it anticipates completing the trial in 4Q01.