• Impliant(Milford, Connecticut) said that its Tops System, the first total motion-preserving posterior spine implant to begin clinical trials, will be unveiled at last week’s meeting of the Spine Arthroplasty Society (North Palm Beach, Florida) in New York. Two papers were presented at the SAS Meeting in addition to a company-sponsored symposium to introduce the Tops System, a mobile posterior device designed to stabilize but not fuse the affected vertebral level to alleviate the pain of degenerative facet arthrosis, spondylolisthesis and spinal stenosis. The device is affixed to the spine via four pedicle screws using a posterior surgical approach. The Tops system is not yet FDA-approved.

• Incisive Surgical (Minneapolis) reported launch of its skin closure system, the Insorb|20 Subcuticular Skin Stapler, for obstetrics and gynecology. The Insorb|20 offers the speed of metal skin staplers with the cosmetic results and comfort of sutures, Incisive said, and it uses bioabsorbable staples that are placed under the skin and then dissolve in a matter of months. “The Insorb|20 combines the benefits of the two closure techniques, sutures and metal staples, by offering the comfort and cosmetic results of sutures with the speed of metal staples,” said John Shannon Jr., president and CEO of Incisive.

• LifeWatch (Buffalo Grove, Illinois) said that a study published in the May 1 edition of the American Journal of Cardiology concludes that 30-day auto-trigger monitors, such as those made by LifeWatch, provide better arrhythmia detection than Holter and standard looping monitors. Researchers examined the records of 1,800 patients selected from the LifeWatch 2003 database, 600 monitored on three different methods of ambulatory cardiac monitoring, including Holter, Looping Memory and auto-trigger Looping Memory. Holter monitors are worn for 24 or 48 hours; Standard Looping-Memory monitors are worn for up to 30 days and are manually activated by the patient to record ECG information both immediately before and after a symptom is detected; and the Auto-Trigger Looping-Memory monitors, also worn for up to 30 days, can self-activate (and also be manually activated) in the event of irregularities. The auto-trigger devices “produced twice the diagnostic yield of standard looping-memory devices and six times the yield of Holter devices,” the researchers said. LifeWatch reports more than 40,000 patients monitored on its LifeStar AF auto-trigger devices, and it is the exclusive provider of auto-trigger AF services. LifeWatch is a wholly owned subsidiary of Card Guard (Rehovot, Israel).

• Medwave (Danvers, Massachusetts), a developer of sensor-based, non-invasive blood pressure measuring systems, reported that a study titled “A Comparison of The Vasotrac With Invasive Arterial Blood Pressure Monitoring in Children After Pediatric Cardiac Surgery” was published in the May 2005 issue of Anesthesia & Analgesia. The researchers concluded that the arterial blood pressure measurements obtained from the Vasotrac system agreed with invasive arterial blood pressure monitoring in children after cardiac surgery and “may be an alternative for obtaining near continuous arterial blood pressure data non-invasively in this pediatric patient population.” Medwave’s Vasotrax Hand Held Monitor, the Vasotrac APM205A NIBP Monitor, the Vasotrac APM205A Model DS, and the MJ23 OEM Module are non-invasive blood pressure monitoring devices.

• Oculus Innovative Sciences (Petaluma, California) reported receiving its first 510(k) clearance from the FDA to market Dermacyn Wound Care, formulated with Microcyn Technology, as a medical device for moistening, lubricating and debriding acute and traumatic wounds and burns. Oculus described Microcyn as a super-oxidized, pH-neutral solution ready for use without requiring dilution or mixing, and needing no special handling or disposal. It is manufactured using a multi-chamber electrolysis process in which ionic species are selectively produced and isolated. This process allows for the production of a pH-neutral solution while minimizing the level of chlorine in the final product. Clearance as a medical device enables Oculus both to market its label claims and enter into negotiations with distributors for commercialization purposes. Dermacyn Wound Care, the first Microcyn Technology product for human use in the U.S., will be available to physicians in June, the company said. The company received CE-marking in November of 2004. It was certified as a Class IIb medical device for treating acute and chronic wounds (e.g. diabetic foot ulcers and burns) as part of a wound care regimen. Microcyn Technology received approval as a disinfectant, antiseptic and sterilant from the Mexican Ministry of Health in 2003 where the product is now commercialized and in use for the treatment of myriad wounds and burns. Dermacyn(TM) Wound Care also received regulatory approval this past November from the Therapeutic Product Directorate, the Canadian federal authority that regulates pharmaceutical drugs and medical devices, as a dermal wound irrigant that facilitates removal of wound debris as it cleanses and debrides.

• OsteoBiologics (OBI; San Antonio), a developer of tissue repair technologies, said it has received a Medical Device License (MDL) authorizing the marketing of its PolyGraft products in Canada and indicated for filling bone voids caused by trauma or surgery. PolyGraft technology provides a biologically and biomechanically stable scaffold during native tissue healing. The porous PolyGraft material is composed of a patented blend of polylactide-co-glycolide, calcium sulfate and polyglycolide fibers which can be fabricated into products such as granules, blocks, wedges and other preformed shapes. The PolyGraft family includes TruGraft BGS Granules, TruFit BGS Plugs, TruWedge BGS Wedge and the TruBlock BGS Block. OBI manufactures bioabsorbable polymeric scaffolds, films, and related instrumentation for the repair and replacement of bone, soft tissue and articular cartilage

• Siemens Medical Solutions (Malvern, Pennsylvania) introduced the Axiom Artis dBC Magnetic Navigation System, designed to improve the accuracy of catheter-based procedures. The technology features a configuration enabling use of the system either as a biplane angiography C-arm system or as a magnetic navigation system. It is based on Siemens’ Axiom Artis dBC, a flat detector biplane angiography system for diagnostic and therapeutic cardiac interventions, and its Axiom Artis dFC Magnetic Navigation System, which enables navigation of medical devices such as catheter- and guidewire-based devices within the heart and coronary vasculature. Combined, these features result in the Artis dBC Magnetic Navigation System, which the company calls “the world’s first biplane magnetic navigation system equipped with digital flat panel detectors in both planes,” and allowing the system to perform as either a biplane or a single plane magnetic navigation system. The system’s flat panel detector technology enables improved image quality by converting X-ray data into digital images, Siemens said. The Axiom Artis dBC system integrates Siemens most advanced digital fluoroscopic imaging system, the Axiom Artis dFC (Flat Panel Detector System), with the Stereotaxis (St. Louis) Niobe Magnetic Navigation System. Using computer-controlled permanent magnets external to the body for orienting the magnetic tip of specially designed catheters and guidewires, the system allows for 360-degree rotation of the catheter for greater precision and better movement.

• Spacelabs (Issaquah, Washington) said that a study published in the February 2005 issue of Blood Pressure Monitoring has validated the accuracy of its Ambulatory Blood Pressure (ABP) monitors over six years of continuous use. The Department of Medical Physics at the Western General Hospital (Edinburgh) conducted the study using a simulator to check the accuracy of the 15 Spacelabs ABP devices used by the hospital from 1998 to 2004, over a range of low, normal and high pressures. Of 1,920 sets of pressures measured, only one was outside accepted limits of the pressures expected from the Spacelabs recorders with the simulated waveforms – that one exceeding the limits by only 1 mmHg. “These findings complement repeated demonstrations of our monitors’ accuracy,” said Bill Neiger, Director of Business Development for ambulatory products at Spacelabs.

• St. Jude Medical (St. Paul, Minnesota) reported that the FDA has approved the IsoFlex P (polyurethane) bipolar, endocardial pacing lead built on the IsoFlex passive-fixation pacing lead platform, offers 55D polyurethane outer insulation, steroid-elution and advanced features designed to improve performance and device longevity. “The IsoFlex P lead demonstrated great pushability and handled very well for precise placement in the heart,” said Thomas Sullivan Jr., MD, of Internal Medicine Associates (Anderson, South Carolina). “It was easy to maneuver and thresholds were very stable.” The IsoFlex P lead enables significant flexibility in ventricular or atrial placement since manufactured in both straight and “J” shapes. Short tip-to-ring spacing is designed to minimize over-sensing to assure appropriate therapy. The small tip electrode surface (3.5 mm) helps provide higher lead impedance, which can reduce pacing current drain and extend the longevity of the implanted device. The tip’s semispherical surface also helps promote more stable thresholds. Reduced diameter size allows threading through a small 7 Fr (2.32 mm) introducer sheath, and the Fast-Pass coating facilitates insertion.