GE Healthcare (Waukesha, Wisconsin) has introduced a new cardiovascular imaging system that it believes will enhance clinicians' ability to diagnose and treat heart disease and enable more precise placement of interventional devices such as stents, balloons and filters. The device, called the Innova 2100IQ, was unveiled at a press conference held during the EuroPCR meeting in Paris in late May.
The company said the Innova 2100IQ is capable of imaging the finest vessels and anatomy of the heart during placement of interventional devices. The new system is expected to play a critical role in helping clinicians treat a growing number of chronic heart and vascular conditions including atherosclerosis, a build-up of plaque that affects blood flow in arteries. Specifically, the device is what GE called a "state-of-the-art cardiac X-ray system that enables cardiologists to clearly visualize fine vessels from the heart to the legs both during diagnostic procedures and during placement of interventional devices."
Laura King, vice president of global interventional, cardiology and surgery for GE Healthcare, said the new system fits in nicely with the company's focus on performance imaging, "making sure that we can see all parts of the body." She noted that the company is dedicated to developing technologies that improve the entire patient experience, from early and more accurate diagnosis to better treatment and management of diseases such as atherosclerosis.
Elsewhere in the product pipeline:
ACMI (Southborough, Massachusetts), which manufactures diagnostic and therapeutic endoscopic instrumentation products and systems, said that its global R&D group has developed the world's smallest digital camera and video color sensor. The company said it plans to incorporate the sensor technology into its line of advanced endoscopic medical devices. ACMI's initial development was a 1 mm color CMOS (complimentary metal-oxide silicon) digital output video sensor. The color sensor operates in both full-motion and still-capture video modes. The company also has designed a micro-miniature lens system that integrates directly into the sensor. The sensor can be tailored to produce high-resolution, full-screen images in both normal and low-light situations.
Advanced Refractive Technologies (formerly VisiJet; Irvine, California), which is developing technologies for the ophthalmic surgical market, said it has received licensed approval from Health Canada to market the EpiLift System in that country. The EpiLift System is being sold in more than 30 countries, including the U.S. The system is the cornerstone of Epi-LASIK, a new method of LASIK corrective vision surgery. When the EpiLift System is used, the epithelium is cleanly separated, at a natural division point in the eye, from the Bowman's layer membrane in an intact sheet of viable tissue. The tissue is then lifted away from the cornea so that a laser can be applied to reshape it. This entire process, Epi-LASIK, produces virtually instant visual results similar to LASIK but with the stable long-term visual outcomes of photorefractive keratectomy. Because it does not involve cutting the cornea or creating a permanent flap, the EpiLift System allows the eye to re-grow the connections with the epithelium, resulting in a safer procedure with a lower risk of complications, according to the company.
Bayer Diagnostics (Tarrytown, New York) has received approval from the FDA for its automated hepatitis B surface antigen (HBsAg) and HBsAg confirmatory assays, which will allow the company to offer more tests on its Advia Centaur Immunoassay System, introduced in 1998. With the approval, Bayer said, it will offer the industry's "only complete FDA-approved" automated panel for acute hepatitis testing, including assays for HBsAg, HCV(1), Anti-HBc IgM and Anti-HAV IgM. In addition to the panel for acute hepatitis, Bayer Diagnostics offers assays for HBsAg confirmatory, anti-HBs, anti-HBc Total and anti-HAV Total. That brings to eight the number of hepatitis assays available on the Advia Centaur, used in hospital laboratories, it said. Some labs will be using the tests as a singular test, while other labs will use the tests as a screening device on a broader panel, said Brad Ditmar, director of marketing for Bayer Diagnostics.
Biotronik (Lake Oswego, Oregon) reported FDA approval and first implant of a Xelos DR-T, the company's new high-energy implantable cardioverter defibrillator (ICD). The device is part of a system that incorporates Home Monitoring Early Detection technology, biphasic II shock capability, and 36-joule shock energy. The first implant of the Xelos DR-T was performed at Maricopa Medical Center (Phoenix) by Chief of Cardiology Edgardo Zavala-Alarcon, MD. "Biotronik's Xelos DR-T combines a higher delivered energy with the revolutionary Home Monitoring feature, so that I can monitor and manage my patients' advancing disease," Zavala-Alarcon said. Events are automatically transmitted from the ICD to the Home Monitoring web site, which provides access to patient and device data anytime, from anywhere.
Boston Scientific (Natick, Massachusetts) reported that the FDA has approved extending the shelf life of its Taxus Express2 paclitaxel-eluting coronary stent system in the U.S. to 12 months from the current nine months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the Taxus system in particular the drug content, drug degradation profile and drug-release mechanism was maintained within FDA-approved specifications at 12 months. The shelf life for the Taxus system outside the U.S. remains unchanged at 18 months.
CardioSoft (Houston) reported the completion of two clinical studies utilizing its new diagnostic cardiology tool, the HFQRS ECG, which measures and characterizes high frequency signals present in the QRS portion of the electrocardiogram, offering enhanced diagnostic information that supplements conventional ECG. The core technology initially was developed by researchers at the Johnson Space Center and is licensed from by CardioSoft from the National Aeronautics and Space Administration. In the first study, involving 45 patients undergoing nuclear medicine scanning for myocardial perfusion, the HFQRS ECG correctly predicted ischemia more than nine out of 10 times. Study results were presented at the recent annual meeting of the International Society of Computerized Electrocardiology. In the second study, the HFQRS ECG performed with similar accuracy when used to assess 60 patients for the presence of cardiomyopathy.
Cholestech (Hayward, California) said that it has been granted patents by the U.S. Trademark and Patent Office (No. 6,881,581) and the European Patent Office (EP 1,329,724) for a new method of measuring high-density lipoprotein (HDL) in human blood. The company believes that this patent provides a different approach than those of other existing patents describing the measurement of HDL and that the patent also permits the development of the Cholestech LDX Lipid Profile/Alanine Aminotransferase (Lipid/ALT) cassette by preventing the interference of the HDL chemistry with the ALT assay on the same cassette.
DePuy Spine (Raynham, Massachusetts), a Johnson & Johnson (New Brunswick, New Jersey) business, reported launch of the Uniplate Anterior Cervical Plate System, a new midline screw-per-vertebral-body system for one- or two-level cervical fusion procedures. The Uniplate System consists of a semi-rigid plate only 10.5 mm wide that, DePuy said, provides stability comparable to traditional cervical plates without requiring fewer screws and thus fewer steps. The company said that the Uniplate System is the narrowest plate on the market, with a thickness of 2.3 mm, and includes a patented locking mechanism, called Tri-lobe Cam-Loc, to secure the screws. The system also includes the Universal Guide, described as an all-in-one tool that acts as a plate holder through which an awl, drill, tap and screws can be inserted.
DOBI Medical International (Mahwah, New Jersey) said that 10 U.S. sites are currently participating in the clinical trial studying its Dynamic Optical Breast Imaging (DOBI) system, known as the ComfortScan system. The ComfortScan system is a non-invasive, nonionizing device that uses light-emitting diodes and gentle external pressure to identify angiogenesis, the growth of new blood vessels, in the breast. The company said that it plans to increase the number of participating sites to at least 20. The clinical trial, which began in 4Q04, is the final element of the company's premarket approval application to the FDA. The study is designed to analyze the ability of the ComfortScan system, as an adjunct to mammography, to assist physicians in making a more accurate diagnosis of an identified breast lesion.
Encelle (Raleigh, North Carolina) said it has completed a second human clinical trial for its E-Matrix treatment of diabetic foot ulcers. The 56-patient feasibility study provides the data necessary to design the next pre-market clinical trial, along with preliminary safety and efficacy results, the company said. The initial clinical trial results found that the company's approach to healing diabetic foot ulcerations demonstrated the potential to improve healing rates with excellent safety.
IMI International Medical Innovations (Toronto) reported launching a pivotal clinical study for its non-invasive breast cancer detection test in collaboration with the University of Louisville (Louisville, Ken- tucky). IMI's test identifies a cancer-associated sugar in a sample of nipple-aspirate fluid, derived from the mammary ducts and is based on a modified version of the company's ColorectAlert and LungAlert technology, which identify a cancer-associated sugar in samples of rectal mucus and sputum respectively.
Johnson & Johnson Wound Management (Somerville, New Jersey), a division of Ethicon, reported Promogran Prisma Matrix as the latest addition to its family of chronic wound dressings. Developed to provide protection and growth in a changing wound environment, Prisma Matrix absorbs destructive components of wound exudate while promoting healthy tissue healing. The combination of collagen, oxidized regenerated cellulose (ORC) and silver-ORC+ delivers a balanced combination of protection and growth for a variety of wound types and conditions at any exudate level.
Medtronic (Minneapolis) reported the U.S. commercial introduction of the Cardioblate BP2 Surgical Ablation System, which offers cardiac surgeons new ease and flexibility in creating ablation lines during open-heart procedures, including the Maze III procedure. The Medtronic Cardioblate BP2 system consists of the Cardioblate BP2 device, a Cardioblate pen and generator. The Cardioblate BP2 device incorporates dual linear electrodes delivering bipolar irrigated radio frequency energy to heart tissue at the touch of a trigger. Saline irrigation facilitates energy flow, allowing swift, deep heating that quickly neutralizes cells in a linear fashion. The low profile, flexible neck and rotating head of the Cardioblate BP2 device eases access to all necessary areas of the heart, the company said. The two 7-cm, malleable electrodes can be individually shaped by the surgeon to conform to the heart's contours for precise tissue contact. The Cardioblate system is the world's first surgical ablation system able to create all necessary lesions of the Maze III procedure without additional equipment, Medtronic said.
NuVasive (San Diego), which makes products for minimally disruptive surgical treatments for the spine, said it has launched the SpheRx Dual Ball Rod (DBR) Minimally Disruptive Fixation System for percutaneous posterior spinal fixation. The latest addition to the company's MAS platform, the SpheRx DBR offers spine surgeon clinical and ease-of-use benefits, as well as seamless integration with the company's NeuroVision Nerve Avoidance System. The SpheRx DBR system performs "instrument-free" compression, which allows the spine surgeon to easily apply up to 5 mm of compression by simply moving the DBR guides with his hands.
OmniGuide (Cambridge, Massachusetts) reported what it said is the first-ever FDA clearance for photonic bandgap technology a type of very efficient mirror in a surgical system. The company said the FDA granted 510(k) clearance of its OmniGuide BeamPath CO2 Mark I laser beam delivery system, designed to enable flexible fiber delivery of a CO2 laser light, for minimally invasive surgery, through a flexible or rigid endoscopes. The system is cleared for multiple indications, including incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues, in a variety of medical specialties.
Orthometrix (White Plains, New York) reported that its Orbasone Pain Relief System has received a Medical Device License from Health Canada for the treatment of chronic plantar fasciitis. The Orbasone is manufactured in the U.S. by Kimchuk (Danbury, Connecticut) and distributed in Canada by Orthometrix. The Orbasone uses high-energy shock waves to relieve chronic heel pain, with the technology derived from a technology used to break up kidney stones without the use of surgery (lithotripsy). Orthometrix said it is working to complete the premarket approval process with the FDA.
Orthovita (Malvern, Pennsylvania), a developer of orthopedic biomaterials, reported that two papers describing the clinical use of Cortoss Synthetic Cortical Bone were published online, ahead of print, in peer-reviewed journals. In one online article in the European Spine Journal, the authors looked at the clinical effects of the use of Cortoss in vertebral augmentation on pain, disability and quality of life in patients with vertebral fractures due to osteoporosis or cancer. They concluded that vertebral augmentation with Cortoss appears to rapidly reduce pain, decrease disability, and improve physical functioning in patients with painful vertebral compression fractures. In a second online article in the European Journal of Plastic Surgery, neurosurgeons evaluated the potential for the use of Cortoss in the reconstruction of bony defects of the anterior skull base. Ten patients with a variety of conditions had their bone defects filled with Cortoss, and then were followed for an average of almost nine months. Hospital stays for those patients were shorter than before, and no post-operative leakage, infections or complications were seen during the period of follow-up.
PerkinElmer (Wellesley, Massachusetts), a provider of genetic screening, drug discovery, life science research and analytical solutions, reported the launch of its BioXpression Biomarker discovery and screening platform. The BioXpression platform introduces new Proteomic Signature Technology that delivers high throughput and ultra-high mass accuracy and stability. The BioXpression Biomarker platform includes the prOTOF 2000 MALDI-TOF mass spectrometer, ProXpression carrier protein-based blood biomarker enrichment kits and BAMF technology from Predictive Diagnostics.
PrognostiX (Cleveland), a start-up company spawned by the Cleveland Clinic's technology transfer and commercialization arm, reported FDA approval of a technology detecting an enzyme from "culprit lesions" of the heart. The in vitro diagnostic, CardioMPO, which will be targeted toward emergency departments for physicians to assess patients presenting with chest pain, detects levels of myel-operoxidase (MPO), an enzyme found in white blood cells. The test is designed to determine whether a patient is in danger of experiencing a heart attack within a 30-day to six-month timeframe.
Quidel (San Diego) said it received third-party validation of its QuickVue Influenza A+B test in a study conducted by scientists at the University of Rochester Medical Center (Rochester, New York). The study found that the QuickVue Influenza A+B assay demonstrated the highest analytical sensitivity among the four tests examined for their effectiveness in detecting the flu.
R2 Technology (Sunnyvale, California) reported the launch of its ImageChecker CT Lung Version 2.0 computer aided detection (CAD) software system and AutoPoint temporal comparison feature for use during review of multi-slice CT chest exams. The second-generation software is designed to maximize physician accuracy and efficiency in finding actionable lung nodules early when treatment can be most effective and tracking nodule changes over time. The system also features expanded PACS integration for increased workflow efficiency. The ImageChecker CT Lung Version 2.0 CAD software system and AutoPoint temporal comparison tool will soon be made available as the only CT Lung CAD option integrated into the Vitrea workstation's CT Lung visualization package, developed by Vital Images (Minneapolis).
The Philips Medical Systems (Andover, Massachusetts) unit of Royal Philips Electronics reported the launch of its new IntelliVue Telemetry System, featuring bidirectional communication between patient-worn transceivers and bedside monitors, and a central station with remote clinician access. Part of Philips' IntelliVue patient-monitoring portfolio, the telemetry system uses cellular technology to ensure seamless information management and more flexible patient monitoring. The IntelliVue Telemetry System, which operates in the protected 1.4 GHz Wireless Medical Telemetry Service band, coexists with Philips digital telemetry systems, wireless bedside and transport monitors, and even a hospital's own WiFi systems. Philips also reported new updates to its IntelliVue Information Center and enhancements to Philips Telemetry System transmitters.
Spectranetics (Colorado Springs, Colorado) received 510(k) clearance from the FDA to market its enhanced lead-locking device (LLD E) featuring design enhancements that it said will save deployment time, improve navigation through tortuous vascular anatomy and provide additional stability to the pacemaker or defibrillator lead being removed. The LLD E may be used alone or in combination with the Spectranetics Laser Sheath. Together, these devices are marketed as CLeaRS (Cardiac Lead Removal System). The LLD E uses Spectranetics' technology that locks onto the entire working length of the inner wall of the lead being removed, providing a stable platform for the lead extraction.
Stereotaxis (St. Louis) reported U.S. commercial availability of its new family of Cronus magnetically enabled .014" vascular guidewires. The guidewire family includes the Cronus Soft Support, Cronus Moderate Support, Cronus CS and Assert Guide-wires. All guidewires have a new distal coating to enhance therapeutic device advancement and a Neo 55 magnet design for consistent magnetic deflection. The Cronus Moderate Support Guidewire has been designed for increased distal shaft support and the new Assert Guidewire has been designed to aid in lesion-crossing applications. The new guidewire family integrates with the Stereotaxis Niobe Magnetic Navigation System to provide in vivo guidewire tip adjustments to facilitate guidewire advancement in tortuous vascular anatomy.
St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its Frontier II system for cardiac resynchronization therapy pacing (CRT-P) to reduce the symptoms of moderate-to-severe heart failure (NYHA Class III or IV) in patients who remain symptomatic despite optimal drug therapy. St. Jude said the Frontier II system is the only device family currently approved in the U.S. for treating patients (NYHA Class II or III) who have undergone an AV nodal ablation for chronic atrial fibrillation. The heart failure indication expands the number of patients who are eligible to have the device implanted. St. Jude said the Frontier II device is the smallest and longest-lasting CRT pacemaker in the U.S., which gives physicians flexibility to optimize patient care without compromising size or longevity. Among the technologies offered in the U.S. version of the Frontier II CRT-P are independently programmable right ventricle and left ventricle amplitudes and pulse widths to meet the individual energy requirements of each chamber of the heart and maintain capture; negative AV/PV Hysteresis and DDT/R Modes Trigger designed to maximize biventricular pacing; and a comprehensive set of atrial fibrillation diagnostics.
Trimedyne (Irvine, California) reported receiving FDA clearance to market its new VaporMAX Side Firing Laser Fiber, which, based upon animal tissue bench testing and published data, vaporizes tissue faster and lasts longer than other currently marketed side firing laser fibers. The VaporMAX Laser Fiber has been cleared for sale for use with Trimedyne's 80-watt Holmium lasers and Lumenis' 60- to 100-watt Holmium lasers, which are cleared for the treatment of benign prostatic hyperplasia. The company said laser vaporization of the prostate is rapidly replacing surgical resection of the prostate, because it typically eliminates the one- to three-day hospital stay and reduces the bleeding, general anesthesia risk, impotence and incontinence of the surgical procedure.
TriPath Imaging (Burlington, North Carolina) and Ventana Medical Systems (Tucson, Arizona) reported that TriPath Imaging has received 510(k) clearance from the FDA for the Ventana Image Analysis System when used with tissues stained for Estrogen Receptor (ER) and Progesterone Receptor (PR). Ventana will globally market the Ventana-branded interactive histology image analysis system from TriPath Imaging. ER and PR analysis aids in the management of breast cancer patients.
Varian (Palo Alto, California) reported the availability of the OnTrak TesTcard 9, a rapid in vitro diagnostic device used in hospitals to determine if pati-ents entering the emergency department could be under the influence of drugs. OnTrak TesTcard 9 provides a qualitative screen for the presence of amphetamines, barbiturates, benzodiazepines, cocaine, metham- phetamines, morphine, phencyclidine, THC and tricyclic antidepressants in urine. TesTcard 9 is a single-step point-of-care test that requires no reagent mixing, timing, incubation or special handling. Results for all nine drugs are available in three to five minutes. Varian said TesTcard 9 test results are stable for up to six hours.