Spinal Concepts (Austin, Texas) entered the minimally invasive spinal surgery market with the introduction of its Access Dilation Port. The system enables spine surgeons to perform traditional spinal disc surgery with a minimally invasive approach using step dilation and a transparent access port for improved visualization during the surgical procedure."Access enables surgeons to use progressively larger dilators to gently move the patient's tissue away with less trauma to the patient compared to a normal surgical incision," said president and CEO Jeff Binder.Access will reduce operating room time, reduce blood loss and tissue damage, and reduce pain and inflammation after surgery. Spinal Concepts is focused on providing spinal implant products used in the treatment of spinal disorders, diseases and injuries.
Elsewhere in the product pipeline:
Alliance Medical (Phoenix) reported FDA 510(k) clearance for reprocessed Ethicon unipolar laparoscopic/endoscopic instruments and said the agency is still reviewing its 510(k) for U.S. Surgical's unipolar laparoscopic/endoscopic instruments. Third- party reprocessors like Alliance were required to submit premarket notifications to the FDA [510(k)s] by Aug. 14, 2001, for most Class II devices to receive marketing clearance by Feb. 14, 2002. After that date, third-party reprocessors can reprocess only devices exempt from premarket notification requirements or those with a cleared 510(k). Alliance submitted 20 510(k)s by the deadline, covering more than 95% of the Class II devices Alliance reprocessed prior to the submission deadline.
Arrow International (Reading, Pennsylvania) reported the successful implant of its LionHeart, a fully implantable left ventricular assist system (LVAS), last month in Pavia, Italy. This means five European locations have implanted the LionHeart. A total of 22 patients, 15 in Europe and seven in the U.S., have received the LionHeart. The first patient to receive a LionHeart implant on Oct. 26, 1999, had surgery on Oct. 21 to remove the device due to the development of small amounts of blood leaking from the pump into the compliance chamber. The patient's natural heart had recovered sufficiently over the nearly two years of assistance that a replacement pump was not required. The device has no power lines or cables protruding through the skin, eliminating a potential source of infection. It is fully implanted in the body and does not replace the heart, but assists in the pumping function of the left ventricle. The device is electrically driven by a wearable battery pack that transmits power noninvasively through the skin to charge internal batteries. Arrow develops a range of clinical catheters and related products for critical and cardiac care.
Aventis Pharmaceuticals (Bridgewater, New Jersey), the U.S. pharmaceutical business of Aventis Pharma AG, reported a landmark, 8,000-patient clinical trial designed to advance the standard of practice for acute coronary. SYNERGY (Superior Yield of the New Strategy of Enoxaparin, Revascularization & GlYcoprotein IIb/IIIa Inhibitors), a multicenter international trial, will study the combination of Lovenox (enoxaparin sodium) Injection, a low-molecular-weight heparin, with new antiplatelet drugs patients with acute coronary syndromes (ACS). The trial is to evaluate the efficacy and safety of Lovenox vs. unfractionated heparin as first-line management in higher-risk ACS patients. The SYNERGY trial is a continuation of the NICE 1, NICE 3 and NICE 4 trials, which studied the safety of using Lovenox for coronary intervention and combining Lovenox with a Gp IIb/IIIa inhibitor. Patients will receive treatment with subcutaneous Lovenox (1mg/kg sc every 12 hours) or unfractionated heparin. The duration of treatment with Lovenox or heparin will be until the completion of percutaneous coronary intervention (PCI) or for patients who do not require PCI, as long as deemed necessary.
Bausch & Lomb (B&L; Rochester, New York) launched its Hydroview hydrophilic acrylic intraocular lens (IOL), for use in cataract surgery, in the U.S. The Hydroview lens is made of a hydrophilic acrylic material with water content of approximately 18%, meaning the lens naturally coexists with the fluids in the eye. The lens has a one-piece design with PMMA haptics, the loops that stabilize the lens within the eye. These modified C-loop haptics, molecularly bonded to the hydrogel lens, keep the lens centered within the eye and provide stability. The lens received FDA marketing clearance in 1999, but B&L delayed its introduction to investigate a small number of reports, from a limited number of sites, of opacification attributed to calcification of the lens optic. Calcification was reported in less than 0.1% of implanted lenses, with fewer than half of those resulting in decreased visual acuity and subsequent explanation. The Hydroview was presented at last month's American Academy of Ophthalmology meeting in New Orleans, Louisiana.
Biomerica (Newport Beach, California) introduced its Aware Breast Self-Examination Pad, which the FDA cleared to market. Aware increases a woman's sense of touch by reducing friction between her fingers and her breast. The Aware pad clings lightly to a woman's skin as her fingers glide smoothly across the breast, making the self-examination more sensitive. "Only 20% to 30% of all women do monthly breast self-examinations, yet self-exams are the very best way for women to find breast irregularities," said Fran Capitanio, Biomerica's diagnostics division president. The Aware product includes the exam pad, directions for use, and an instructional video. The product will soon be available to consumers through physicians and at drugstores nationwide. Biomerica's diagnostic division manufactures and markets advanced diagnostic products used in the home, hospitals and physicians' offices for the early detection of diseases.
Cambridge Heart (Bedford, Massachusetts) said that a Current Procedural Terminology (CPT) code with a specific Medicare payment amount for its Microvolt T-Wave Alternans testing has been published in the Federal Register. Effective Jan. 1, CPT code 93025 may be billed electronically. The national Medicare payment amount for the test will be $263.53. The code is unique to Microvolt T-Wave Alternans and may be used alone or in conjunction with other diagnostic cardiovascular tests when submitting for reimbursement of claims to either Medicare or private insurers. The Microvolt T-Wave Alternans Test measures subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. Research has shown that patients with symptoms of or at risk for life threatening arrhythmias who test positive for Microvolt T-Wave Alternans are at significant risk for subsequent sudden cardiac events, including sudden death.
CardioDynamics International (San Diego, California) received FDA 510(k) clearance for its second generation BioZ.com II system. Shipments will begin late in the company's fourth fiscal quarter. The new BioZ.com II offers notable design features including BioZ Crystal Signal Stabilization (CS2) and BioZ FlexReport software. The addition of CS2 to the existing DISQ (Digital Impedance Signal Quantifier) technology will allow for enhanced signal stability. The FlexReport allows physicians to design reports customized to meet individual clinical needs. The elements of the BioZ.com II were designed for integration into the original BioZ.com, the BioZ dTEL, and future products. This regulatory approval and the advancements included in this new generation of ICG monitoring eliminate the near-term need to pursue BioZ dTEL product clearance, the company said. The BioZ.com II will be its initial solution for the dialysis market.
Cbyon (Palo Alto, California) entered the spinal surgery market with a new line of spinal modules announced at the annual meeting of the North American Spine Society in Seattle, Washington. Running on the Cbyon Suite volumetric surgical navigation platform, it includes features such as Perspective Volumetric Navigation and Image-Enhanced Endoscopy. The Fluoroscopy module is designed specifically for spinal applications and is capable of augmenting standard fluoroscopic images with the position of tracked surgical instruments in real-time during a procedure. The company said that because the surgeon's instruments are tracked in real-time and overlaid on actual fluoroscopic images of the patient's anatomy, the surgeon no longer needs to maintain constant visualization of the instrument tip via updating fluoroscopic images, reducing radiation exposure and allowing less-invasive surgical procedures.
ChromaVision Medical Systems (San Juan Capistrano, California) said data from a study conducted at the University of Texas Southwestern Medical Center (Dallas, Texas) was presented in an article on anatomical pathology in the October issue of the American Journal of Clinical Pathology. The study, involving 189 breast cancer cases, compared ACIS-assisted immunohistochemical (IHC) quantitation with the manual IHC assay and concluded that the ACIS method represented a substantial improvement over manual testing for objective evaluation of HER2-neu status. The article also said that, compared to the manual method, the ACIS IHC assay is more objective, consistent and sensitive, and has a higher concordance rate with the FISH assay, an alternative method of testing which measures the HER2-neu gene rather than the protein. The HER2 oncoprotein is over-expressed in 25% to 30% of breast cancer cases and is linked to poor prognosis and shortened survival time. ChromaVision markets Automated Cellular Imaging System (ACIS), a digital microscope system with the ability to detect, count and classify cells of clinical interest based on color, size and shape to assist pathologists in making critical medical decisions.
Coronado Industries (Fountain Hills, Arizona) reported FDA approval of its premarket approval study protocol. Information needed to satisfy PMA requirements on the Pneumatic Trabeculoplasty (PNT) device to treat glaucoma will be gathered in this study. PNT, a two-minute, noninvasive procedure, is being evaluated as a cost-effective alternative for the treatment of the most common types of glaucoma – open angle and pigmentary. During PNT, a suction device is applied to the eye for two minutes with the intention of reducing intraocular pressure. Coronado and Novartis AG (Basel, Switzerland) are continuing to complete an agreement covering the exclusive global licensing and distribution rights to the product.
CV Therapeutics (Palo Alto, California) received a notice of allowance from the U.S. Patent and Trademark Office for a patent application titled "Partial Fatty Acid Oxidation Inhibitors in the Treatment of Congestive Heart Failure." Allowed claims include the use of all partial Fatty Acid Oxidation (pFOX) inhibitors, including ranolazine, for the treatment of congestive heart failure. Ranolazine has not been approved for marketing by the FDA or other foreign agencies but is being investigated in clinical trials subject to a U.S. investigational new drug and applicable foreign authority submissions.
Cygnus (Redwood City, California) said its supplemental premarket approval application for use of the GlucoWatch Biographer by children and adolescents between ages 7 and 17 has been granted expedited review status by the FDA. The GlucoWatch Biographer automatically and noninvasively measures glucose collected through the skin, not from blood, and displays glucose levels as often as every 20 minutes, for up to 12 hours. It also creates an electronic diary, storing up to 4,000 values to detect trends in glucose levels. In addition, users can set personal glucose alert levels so that an alarm sounds if readings are too high or too low. The GlucoWatch Biographer is approved in the U.S. for adults 18 and older, and has received CE mark approval in Europe.
Cytyc (Boxborough, Massachusetts) said that two recently published studies highlight the improved performance of the ThinPrep Pap Test. Results of one study appeared in Gynecologic Oncology. In the study, conducted in Shanxi Province, China, patients underwent HPV testing, fluorescence spectroscopy, the ThinPrep Pap Test, a visual inspection diagnosis, and colposcopy with multiple biopsies. Authors reported that the ThinPrep Pap Test had a 94% sensitivity for the detection of cervical intraepithelial neoplasia and a 100% sensitivity for cancer. Another study, published in the American Journal of Obstetrics and Gynecology, concluded that the ThinPrep Pap Test improves diagnosis of low-grade and high-grade squamous intraepithelial lesions compared to the conventional Pap smear. The article also demonstrated improved sample adequacy with the ThinPrep method.
Diagnostic Products (DPC; Los Angeles, California) is offering a new allergy screen for the qualitative detection of IgE antibodies specific to inhalant allergens in serum, as an aid in the differential diagnosis of atopic allergy. The Immulite 2000 AlaTOP Allergy Screen is a chemiluminescent, enzyme-labeled, sequential immunoassay for use with the Immulite 2000 Automated Analyzer. DPC said it represents a "significant advance" over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. In vitro allergy screening tests followed by allergen-specific IgE tests can help the physician identify the allergen (or allergens) to which an individual is sensitive, the company said. The Immulite 2000 AlaTOP Allergy Screen is available outside the U.S. in a 200-test size.
DiaSys (Waterbury, Connecticut) launched its disposable product line for collecting and processing patient specimens for intestinal parasite analysis to a worldwide market estimated to be in excess of $65 million. The Parasep product line is only one of several products acquired by DiaSys as a result of the company's purchase of Intersep Ltd., a UK-based manufacturer of consumable laboratory products, supplies and test kits. DiaSys develops medical laboratory instrumentation, consumables, reagents and test kits with applications in urinalysis, microbiology, electrophoresis, immunology and cytology.
Dynamic Imaging (Livingston, Scotland) and iDART (San Francisco, California) received FDA 510(k) clearance for Diasus, a high-frequency, application-specific diagnostic ultrasound system. Designed for high-resolution musculoskeletal and breast imaging, Diasus uses three ultra wide-band probes, in a frequency range between 5 MHz and 22 MHz. High frequency ultrasound offers detailed imaging of soft tissue and bony anatomy, revealing tendon tears, assisting in the diagnosis of chronic tendonitis, showing abnormal nerve mobility, as well as edema of the nerve, as seen in carpal tunnel syndrome of the median nerve. Ultrasonic examination of the small joints in the hands and wrist assists in early detection of rheumatoid arthritis. Dynamic makes diagnostic ultrasound systems for medical and veterinary applications.
Genomics Collaborative (GCI; Cambridge, Massachusetts) was issued U.S. Patent No. 6,294,339, titled, "Method of Diagnosing and Treating Increased Risk of Death from Community Acquired Pneumonia Associated with A-Allele of TNFalpha-238 Polymorphism." GCI said it believes this technology may help develop a diagnostic screening tool for clinicians to determine predisposition to pneumonia and sepsis and, longer term, may lead to a significant therapeutic target.
GlaxoSmithKline (London) reported FDA approval of Coreg (carvedilol) for the treatment of severe heart failure. Coreg is already approved for the treatment of mild-to-moderate heart failure. Coreg is now the only beta-blocking agent indicated to increase survival in mild, moderate and severe heart failure patients, the company said. Coreg blocks all three receptors believed to play a role in the progression of heart failure. The FDA approval is based on a review of data from the COPERNICUS (CarvedilOl ProspEctive RaNdomIzed CumUlative Survival) trial, which showed that treatment with Coreg reduced the risk of death in patients with severe heart failure by 35% compared to placebo. COPERNICUS was a multicenter, double-blind, randomized controlled trial of Coreg vs. placebo involving more than 2,200 patients in some 300 hospitals in 21 countries.
Hologic (Bedford, Massachusetts) received FDA marketing clearance for the Lorad Affinity Mammography System. Lorad (Danbury, Connecticut), a division of Hologic, produces mammography and minimally invasive breast biopsy systems. Affinity is a screen-film mammography system developed as cost-effective but with performance characteristics similar to high-end systems. The company said it expects full commercial production of the Affinity to begin in 1Q02. Hologic develops X-ray systems that incorporate direct-to-digital radiographic imaging technology for both women's health and general radiographic applications.
Imaging Research (St. Catharines, Ontario) released Version 6.0 Rev 2.0 of its image analysis solution, ArrayVision, an industry standard for analysis of gene expression and protein arrays. This new revision incorporates features for spot segmentation, improved auto alignment and additional data export functions. ArrayVision 6.0 Rev. 2.0 features spot segmentation and improved auto alignment algorithms. ArrayVision is available in both desktop and server versions.
LaserSight (Winter Park, Florida) reported FDA approval of its PMA supplement to increase the laser pulse repetition rate of its LaserScan LSX precision microspot scanning system to 200 Hz for the Lasik treatment of myopia and myopic astigmatism. According to the company, the LSX is the only laser system approved in the U.S. combining the efficiency of a 200 Hz laser repetition rate, the precision of a small microspot and the highest resolution of optimized low laser fluence.
Lawrence Livermore National Laboratory (Livermore, California) reported a rapid-detection technique to identify salmonella within hours rather than as long as a couple weeks. A paper about the development of a DNA-based detection system appeared in Applied & Environmental Microbiology. In a year-long effort, several potential unique strands of DNA in a strain of salmonella known as salmonella enteritidis were identified. Those pieces of DNA were then compared with the genomes from other strains of salmonella closely related to salmonella enteritidis to ensure they were unique to the enteritidis strain. If the process continues to proceed well, it would likely be used by the California Animal Health & Food Safety Laboratory for future testing, pending approval by that organization and the FDA, Lawrence Livermore said.
Lenslet Labs Ltd. (Ramat Gan, Israel) unveiled what it called the world's first commercial optics-based digital signal processing technology. The system boosts the performance of Digital Signal Processing, setting new performance levels of Tera operations per second, in a single component, the company said. Based on a proprietary optical core, it takes multiple electronic digital inputs, converts them into optical signals (photons), performs the desired computation at light speed in the optical core, and then converts the optical output signals back into digital electronic form. Unlike traditional DSPs, the Optical Digital Signal Processing Engine (ODSPE) uses mathematical transforms rather than instructions as its basic atomic operations. This accelerates software development time by mapping computation-intensive algorithms onto the ODSPE at a conceptually higher level of abstraction. Lenslet said its ODSPE is re-configurable and can be tailored to the required transform type.
LifeNet (Virginia Beach, Virginia) was awarded a patent by the U.S. Patent and Trademark Office for a bone demineralization process and the bone produced thereby. The process allows for the production of maximal osteoinductive demineralized ground bone in a controlled and reproducible fashion by reproducing a residual calcium level of approximately 2 mg%. LifeNet said the ability to reproduce a residual calcium level of approximately 2 mg% in ground demineralized bone has been demonstrated to produce optimal levels of osteoinductivity. Its demineralization technology encompasses a demineralized bone calcium range of 1 to 4 mg% levels of residual calcium by dry weight. The goal of the technology is to provide demineralzied bone for a variety of applications that is optimally osteoinductive. LifeNet says it is the largest nonprofit and full-service tissue banking system in the world.
LightLab Imaging (Westford, Massachusetts) began human cardiovascular studies using its Optical Coherence Tomography (OCT) ultra-high resolution imaging platform and its .014" ImageWire. The study is being conducted at the Siegburg Heart Center (Siegburg, Germany). The OCT platform uses advanced photonics and state-of-the-art signal processing techniques to bring microscopic imaging into the body. Using a single strand of optical fiber .006" in diameter, the LightLab .014" ImageWire enables clinicians to obtain images of coronary anatomy at resolutions approximately 10 times higher than any conventional imaging technology currently available. OCT uses infrared light instead of sound waves. The much higher bandwidth of light enables the OCT platform to achieve image resolutions of 10 micrometers to 12 micrometers vs. 100 micrometers for ultrasound.
Maxxon (Tulsa, Oklahoma) has filed a U.S. patent application for its new Blood Extraction Safety System. The system automatically retracts the needle safely after being used to draw blood. A single-handed, vacuum-operated safety blood extraction apparatus, it retracts the used needle into the barrel after use. The system looks like and is compatible with vacuum blood drawing systems available on the market, so no specialized training or procedure is needed to use this new technology.
Merge Technologies (Milwaukee, Wisconsin) released ImageChannel, a product combining Merge's storage, toolkit and integration technologies and eFilm Medical's (Toronto, Ontario) design of visualization technology for on-demand image display, measurement, interactive window leveling, cross referencing and study comparison. The release also incorporates wavelet technology from Pegasus Imaging (Tampa, Florida).
Motorola Life Sciences (Northbrook, Illinois) shipped its first eSensor DNA Biochip Assay to detect mutations in the Cytochrome P450 gene superfamily, to Sanofi-Synthelabo (Malvern, Pennsylvania) for use in clinical trial studies of candidate therapeutics. As part of a recently signed agreement, Motorola shipped over 500 chips and eSensor, manufactured at its Pasadena, California, facility, to Sanofi-Synthelabo. These Cytochrome P450 chips will be used by Sanofi-Synthelabo in Phase I testing. The chip will be used initially to gather data and help scientists detect important genetic mutations associated with a patient's ability to metabolize particular drugs. The eSensor relies on bioelectronics, using organic molecules to form electronic circuit elements. This technology can detect and quantify up to 36 DNA or RNA targets simultaneously. This information may help pharmaceutical companies correlate adverse reactions with a particular genotype during early phases of clinical trials, and thus streamline selection of patients for the more costly later phases, to focus on those who will most benefit from a new drug.
Nidek (Fremont, California) received a pair of FDA clearances: a supplemental PMA for the Nidek EC-5000 Excimer Laser System to utilize an increased optical zone during the LASIK procedure, and 510(k) clearance for the ConfoScan Confocal Microscope, developed by Nidek Technologies America (Greensboro, North Carolina). The EC-5000 now can be used for a 6.5 mm optical zone in the treatment of myopia and myopia with astigmatism. This expanded optical zone may be used with a 7.5 mm transition zone in treating myopia and myopia with astigmatism using LASIK. The increased optical zone allows refractive surgeons to treat larger areas on the cornea during the procedure, which may also prove beneficial to patients with larger than normal pupils who previously were not candidates for LASIK, the company said. The ConfoScan is a digital corneal confocal microscope that allows corneal specialists, refractive surgeons and ophthalmologists to record digital images of in vivo corneal layers. It can be used for pre operative assessment of corneal health; diagnose early signs of keratoconus and dry eye, as well as indicating overall endothelial viability, measuring flap depth, interface healing quality and epithelial layer analysis.
Ortec International (New York) reported that a preliminary review of the first 13 patients completing its pivotal venous leg ulcer trial using its cryopreserved form of OrCel indicated that 69.2% of patients achieved complete wound closure in 12 weeks. The four patients who had not achieved 100% wound closure within 12 weeks achieved at least 90% wound closure. The data also showed that no clinically relevant immune responses were evident in any of the patients treated with the frozen product. The patients were treated to assess whether there would be any negative reactions to treatment with a cryopreserved version of OrCel. The patients were treated at five of the 35 clinical centers expected to be involved in the trial. Patients were treated with a single application of OrCel per week, for up to four weeks. Ortec is a tissue-engineering company involved in technology to stimulate the repair and regeneration of human tissue.
PharmaSonics (Sunnyvale, California) reported final results for SILENT (Sonotherapy for In-Lesion Elimination of Neointimal Tissue), the Phase I registry of the company's Intravascular Sonotherapy System for restenosis following coronary stenting. Sonotherapy, which uses a selective spectrum of therapeutic ultrasound energy delivered through a standard catheter, is under investigation for reducing the incidence of restenosis in patients treated with coronary stents. The early results of SILENT previously led to FDA approval of the ongoing SWING trial, a Phase II pivotal trial of sonotherapy for the prevention of stent restenosis in patients with newly implanted (de novo) stents. SILENT examined short- and mid-term safety and clinical feasibility of intravascular sonotherapy to prevent restenosis in native coronary arteries immediately following stent implantation. The trial comprised single-lesion treatment of 102 patients at 11 sites worldwide, of which 93 received complete Sonotherapy treatment, with only 10.8% of them requiring target lesion revascularization at the nine-month endpoint of the trial. Six-month data resulted in CE mark approval.
Sanarus Medical (Pleasanton, California) reported availability of the Centrica Rotational Core Biopsy system and clearance by the FDA. This new device enables surgeons to obtain breast tissue samples that lead to a more accurate diagnosis. Sanarus said Centrica marks a new approach to breast tissue sampling that is more cost-effective and less invasive than open, surgical biopsy options. The procedure is performed through a 3 mm to 4 mm incision in the breast. This small incision site, which allows the procedure to be performed in a surgeon's office, requires no general anesthesia or stitches. Under ultrasound visualization, a small needle is placed directly into the tissue. Once placement is confirmed via ultrasound, the immobilized lesion is stick frozen for a few seconds, which secures the targeted tissue and enables a large tissue sample to be removed for evaluation.
Smith & Nephew (Memphis, Tennessee) received premarket approval from the FDA to market Exogen 2000+, a noninvasive ultrasound therapy for the treatment of fresh fractures and delayed healing bone fractures. Exogen 2000+ will be available in the U.S. market early next year. The device, which can be programmed into eight languages, was introduced in Australia, Canada and parts of Europe in May. Compared to the Exogen 2000, the new device has a smaller treatment head that can be more easily placed directly over the fracture site. It can also be used on smaller parts of the body, such as the wrist. It allows for easier access when used with external fracture fixation devices, such as the Ilizarov Circular Fixator. These devices are attached externally to the body to restore correct alignment to fractured limbs. Smith & Nephew develops tissue repair products, primarily in the areas of orthopedics, endoscopy, wound management and rehabilitation.
Smith & Nephew's Endoscopy Division (Andover, Massachusetts) introduced its HandTact Instrument Set, a group of lightweight, palm-sized laparoscopic scissors, dissectors and graspers designed for surgeons to use with their non-dominant hand during hand-assisted laparoscopic surgery (HALS). The HandTact Instrument Set includes an atraumatic grasper, used to grasp or retract tissue; the Maryland dissector, used for suturing and fine separation of tissue; and a needle holder, used to hold or receive a suturing needle during HALS procedures.
Somanetics (Troy, Michigan) and Cornell University's Weill Medical College (New York) released results of a new study reporting that neurological complications resulting from cardiac surgery were decreased by maintaining regional brain blood oxygen saturation at adequate levels. Monitoring with Somanetics' Invos Cerebral Oximeter patient monitoring system, and making interventions as needed, significantly decreased the incidence of stoke and coma, the study said. The 286-patient results were released in conjunction with the American Society of Anesthesiologists annual meeting in New Orleans, Louisiana, earlier this fall. The surgical team attempted to maintain cerebral oxygen saturation above 40% for the intervention group's patients. The intervention group had a significantly lower incidence of regional oxygen saturation levels – under 30% – and incidence of stroke and coma than the control group. Patients in the control group had surgery and anesthesia performed with no interventions attempted. Invos continuously monitors changes in the regional blood oxygen saturation in the brain. The cerebral oximeter provides information by transmitting and detecting visible and near-infrared light through SomaSensors, single-use sensors that are placed on both sides of a patient's forehead. Because the sensors are noninvasive, there is no skin penetration, as with needles, or associated risk of infection.
St. Jude Medical (St. Paul, Minnesota) reported the first implant of its Identity XL DR pacemaker, at Kerkhoff Heart Center (Bad Nauheim, Germany). The Integrity pacemaker includes St. Jude's AFx feature set, designed to better manage pacemaker patients suffering from atrial fibrillation. The Identity family of pacemakers combines St. Jude's bradycardia technologies in a single platform. It includes three models: the DR, a dual-chamber pacemaker of 8 cc, 18 g size; the XL DR, a dual-chamber pacemaker with battery components and circuitry designed for long life; and the SR, a single-chamber configuration of 7.9 cc, 17 g size. Identity pacemakers offer features of St. Jude's Integrity AFx and Integrity micro pacemaker families, plus several new diagnostic features, including stored electrograms, Automatic Mode Switch log and AFx histogram.
SurgiLight (Orlando, Florida) filed an investigational device exemption application with the FDA, marking another step in the company's efforts to obtain FDA clearance of a procedure to treat presbyopia. The filing requests the initiation of clinical trials at seven U.S. sites involving 350 patients. Prior clinical data were collected at four overseas sites wherein the SurgiLight OptiVision (formerly the IR-3000) Er:YAG laser was employed to remove certain eye tissue. Results showed reversal of the presbyopia condition in nine of every 10 eyes of the more than 100 eyes treated, extending up to one year after surgery. The company said there have been no serious complications for the targeted tissue removal, called scleral ablation. All but six patients, the latter treated before surgeons had logged optimal experience in the new procedure, were subsequently able to read without glasses; more than 80% were able to read any text without such aid. Follow-up on some patients extended for one year with no statistically significant regression.
Surgin Surgical Instrumentation (Tustin, California) received 510(k) clearance from the FDA to sell its Prizm Lasik Blades for Moria SA's microkeratome. The approval comes shortly after a ruling by the U.S. District Court for the Eastern District of Virginia in which the court dismissed a lawsuit filed by Moria SA and Moria Inc. against Surgin for false and misleading advertising.