Karl Storz Endoscopy-America (Culver City, California) launched its Tricam 3D Imaging System with a live telesurgery transmission during the Society of Laparoendoscopic Surgeons (Miami, Florida) meeting in Las Vegas, Nevada, earlier this fall. Used for minimally invasive, endoscopic surgery, the system's advantage over some other 3-D systems is that it uses one camera that includes a single-channel, stereo telescope, which transmits images to the camera head. Most other systems use two cameras, said Jacqueline Benz, product marketing manager for Karl Storz.
"Every camera out there that has been used with endoscopic surgery prior to this has been 2-D," Benz said. "In other words, you lose the 3-D capability that a surgeon has when he's doing open surgery, because we all see in 3-D." She added, "With the minimally invasive surgery, they're looking at a monitor, so they've lost that 3-D, that depth perception that you have with the naked eye. What this camera does is try to imitate that."
Once the image is transmitted to the camera head, the camera then shutters rapidly between the right eye and the left eye and sends the 3-D image to the monitor. In order to view the 3-D image, a surgeon only has to wear a pair of special polarizing glasses that are similar to sunglasses, the company said. Benz said the reason Karl Storz used one camera is, "first of all, we wanted to design it ourselves, and we didn't want to have it from an outsider or third party."
The telesurgery demonstration, which originated in a surgery suite at Northside Hospital (Atlanta, Georgia), got a good reception among the 450 to 500 surgeons that Benz estimated saw the demonstration at the Las Vegas meeting. The surgeons in the audience were given the special polarizing glasses to wear during the telesurgery as surgeons on screen explained what was taking place.
"The comments were that they couldn't believe that the 3-D was that pronounced to them, especially on these large screens, the quality, the clarity, the detail, which speaks to the camera capabilities in our video camera," Benz said.
Elsewhere in the product pipeline:
American Medical Systems (AMS; Minneapolis, Minnesota) reported launch of the first product in its BioArc family of incontinence treatments, the BioArc SP Sling System, offering a choice of a biologic graft material matched with a self-fixating synthetic sling. A hybrid system, the BioArc SP sling is composed of synthetic and biologic materials, and is formed with the surgeon's choice of type, size and thickness of biologic tissue for urethral support customized to the patient's needs. The system uses the same suprapubic approach and benefits of a self-fixating polypropylene mesh as the AMS SPARC Sling System used in more than 50,000 procedures. The BioArc SP sling joins a set of minimally invasive surgical options that AMS has developed to treat urinary incontinence in women, including the Monarc Subfascial Hammock and the Sparc and In-Fast Sling Systems.
bioM rieux (Durham, North Carolina) received FDA clearance for its VIDAS D-Dimer extended range D-dimer assay to exclude the presence of suspected deep vein thrombosis and aid in the diagnosis of pulmonary embolism in outpatients.
Bio-Rad Laboratories (Hercules, California) received FDA 510(k) clearance for its D-10 Hemoglobin A1c system, which includes both the D-10 instrument and Hemoglobin A1c test kit. This fully automated system provides the same level of precision and throughput offered in the company's larger Hemoglobin A1c monitoring systems, the company said. Bio-Rad is a multinational manufacturer of life science research products and clinical diagnostics.
Boston Scientific (Natick, Massachusetts) has received marketing clearance in Canada for its Taxus Express2 paclitaxel-eluting coronary stent system. The company reported that Health Canada's Therapeutic Products Directorate approved the use of all sizes of the Taxus stent system and that it plans to launch the product immediately in that country. Taxus is designed to treat coronary restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. It has previously been approved for sale in Europe and other international markets and is awaiting approval by the FDA.
B. Braun Medical (Bethlehem, Pennsylvania) received FDA clearance for its Ultrasite Needle-Free IV system with power injectors up to 300 psi helping to prevent exposure to dangerous bloodborne pathogens in the radiology suite. B. Braun said it is the first company to receive FDA 510(k) clearance for this type of technology. The Ultrasite is a patented valve with a Positive Displacement Design that uses an internal plunger to expel fluid when the Luer taper is removed, preventing blood from being drawn back into the IV system. The company said the design offers exceptional flow rates while enabling it to be used across a variety of IV therapy applications.
Cambridge Heart (Bedford, Massachusetts) has begun the MASTER (Microvolt T-Wave AlternanS TEsting for Risk Stratification of Post MI Patients) clinical trial. The trial will target post-myocardial infarction (MI) patients whose hearts have been damaged by previous heart attacks. Funded in part by Medtronic (Minneapolis, Minnesota), the study will evaluate the ability of Cambridge Heart's Microvolt T-Wave Alternans (MTWA) Test in predicting which patients may be at greater near-term risk of sudden cardiac death and can therefore have the greatest benefit from ICD implantation. MTWA detects extremely subtle electronic fluctuations in a person's heartbeat that are not visible on electrocardiograms. About 1,800 patients will be enrolled in the MASTER trial. Results of the clinical trial are anticipated in 2006.
Candela (Wayland, Massachusetts) has received expanded wrinkle clearance from the FDA to market its Smoothbeam diode laser for the non-invasive treatment of wrinkles on the face. Smoothbeam remodels collagen in the upper layers of the skin to reduce the appearance of wrinkles and acne scars using its LASR process. Smoothbeam creates a mild thermal injury just below the skin's surface. The body's natural healing response stimulates the deposition of new collagen, smoothing out wrinkles and softening the appearance of acne scars, according to the company.
Canon (Irvine, California) said that Eye Q Sharp, a new software digital imaging and information management system that will deliver medical imaging network connectivity options and services for the company's Eye Q Digital Retinal Imaging System, has been introduced by the medical systems division of Canon U.S.A. The Eye Q Sharp debuted at the International Vision Expo in Las Vegas, Nevada. Canon said the Eye Q Sharp is the first Microsoft .NET open architecture-based product for clinical imaging applications. The system will enable users to capture instantly high-resolution digital images that can be reviewed, analyzed, printed and digitally communicated anywhere in the world.
Corgentech (South San Francisco, California) has completed patient enrollment in a pivotal Phase III clinical trial to evaluate its lead product, CGT003, a therapy for the prevention of graft failure following coronary artery bypass graft surgery. CGT003 is an E2F decoy, an oligonucleotide that binds to and inactivates the pivotal cell-cycle transcription factor E2F, administered in Corgentech's drug-delivery device. CGT003 also is being evaluated in a Phase III clinical trial for the prevention of peripheral arterial bypass graft failure. The FDA will require both the coronary and peripheral Phase III trials for approval, and has granted CGT003 fast-track status for those indications.
Cytogen (Princeton, New Jersey) reported the publication of clinical data showing that ProstaScint-guided prostate brachytherapy results in a high probability of actuarial four-year biochemical disease-free survival for patients with localized prostate cancer. The results, reported in the October edition of the International Journal of Radiation Oncology, were gleaned from a study of 80 patients who underwent radioimmunoguided (ProstaScint) permanent prostate brachytherapy.
Edwards Lifesciences (Irvine, California) has launched the Tricentrix holder system for use with the Carpentier-Edwards Perimount Plus mitral pericardial valve in the U.S. The system, used to hold and position the replacement valve during mitral heart valve surgery, makes it easier to implant the Perimount mitral tissue valve. The holder's ultra-low-profile design creates better visualization and operating space for the surgeon by allowing the valve to quickly and easily "parachute" into the precise opening of the patient's native valve. The holder offers one-piece removal and a quick-release handle, providing efficiencies that can help decrease operating time, Edwards said.
Evit Labs (McClellan, California) reported FDA approval for the Sonik LDI Nebulizer for asthma and chronic obstructive pulmonary disease. The Sonik LDI is based on an aerosolization process that is superior to existing nebulizers because it is significantly faster, portable, quiet, less expensive to manufacture, and convenient, the company said.
Guidant (Indianapolis, Indiana) reported completion of patient enrollment in its second clinical trial designed to evaluate carotid artery stenting as a minimally invasive alternative for patients who are ineligible for current surgical options or at high surgical risk. ARCHeR RX (Acculink for Revascularization of Carotids in High-Risk Patients) is a prospective, nonrandomized, multi-center, single-arm study that enrolled a total of 145 patients in five countries. The trial using Guidant's embolic protection device, the RX Accunet, and a rapid-exchange stent system, the RX Acculink carotid stent was designed to show equivalence in the safety and performance of Rapid Exchange (RX) versions of the devices with the over-the-wire Accunet and Acculink devices. The primary endpoint for the study is combined death, stroke and myocardial infarction at 30 days.
Guideline (Newtown, Pennsylvania) has developed Hand Guide, a hand-held obstacle detection device designed to increase mobility for individuals who are visually impaired. Hand Guide is designed to be used in conjunction with a cane or a guide dog by detecting objects up to four feet away in any direction in which it is pointed. When the device detects something, it signals a warning by vibrating or chirping. It detects stationary, hanging or moving objects or people without contact to either side and at any level including face or shoulder height, indoors or outdoors.
HydroCision (Andover, Massachusetts) said the FDA has granted marketing clearance for its SpineJet Curette device for open and minimally invasive spine surgery. It is the first surgical instrument to combine the tissue removal properties of a curette with the tissue consuming and evacuation power of the Hydrodrive fluidjet-based technology, the company said. The SpineJet Curette will provide spine surgeons with a powered device that will allow them to more quickly and effectively prepare the disc space for implantation of a fusion graft or an artificial disc or nucleus. The powered device will greatly reduce the number of instrument exchanges in the interbody space, thereby reducing potential patient complications.
IDev Technologies (Houston, Texas) has received 510(k) clearance from the FDA to market the AKonya Eliminator thrombectomy device in the U.S. The device is cleared for use in the declotting of synthetic dialysis grafts. The AKonya Eliminator is a non-motor driven mechanical thrombectomy device that places the degree of mechanical interaction back into the hands of the clinician, the company said. Axial and rotational manipulation of the device's Thrombasket, a woven mesh structure, serves as the mechanism of action for thrombus maceration. The device's high radial force and vessel wall compliance allow for removal of adherent clot or highly calcified lesions in various dialysis graft sizes.
Kensey Nash (Exton, Pennsylvania) said that it has initiated a clinical study of a new version of its TriActiv Balloon Protected Flush Extraction System for carotid stenting procedures. The new device represents an extension of the company's core TriActiv technology that is approved for sale in the European Union and is under clinical investigation in the U.S for treating diseased saphenous vein grafts. The TriActiv System for carotids was clinically tested for the first time and was successfully used to provide protection from potential stroke-causing emboli by actively removing debris during carotid stenting procedures.
MacroPore Biosurgery (San Diego, California) received FDA clearance to expand its marketing claims for SurgiWrap, its thin bioresorbable sheet platform technology. The newly cleared indication is for the minimization of soft-tissue attachment to SurgiWrap in case of contact with the surrounding viscera. This expanded marketing indication brings SurgiWrap closer to the European indications that allow MacroPore Biosurgery to market, in Europe, for the control of postsurgical adhesions. The company will now be marketing thin sheet products in the U.S. under the name SurgiWrap MAST.
Masimo (Irvine, California) reported the release of the 2004 Radical. The device debuts Masimo SET V4.1, a high-sensitivity, specificity and fidelity pulse oximetry technology; advanced probe off detection technology designed to minimize the risk of false measurement when the probe becomes detached from the patient; a high-resolution ClearVue blue LCD display technology; and the A6 alarm system, delivering up to 85 decibels of sound during alarm. The device is equipped with a detachable battery providing up to eight hours of use, as well as an optional extended battery giving up to 36 hours of battery life.
Milestone Scientific (Livingston, New Jersey) said the FDA has approved marketing of its SafetyWand disposable handpiece, an injection device that incorporates safety engineering sharps protection features to aid in the prevention of needlesticks. The SafetyWand is the first patented injection device to be fully compliant with OSHA regulations under the federal Needlestick Safety Act while meeting the clinical needs of dentists, the company said.
Neoprobe (Dublin, Ohio) received FDA clearance to begin commercial marketing of the Quantix/ OR system for the intraoperative measurement of blood flow. Quantix/OR consists of an angle-independent ultrasound probe that obtains signals directly from the blood vessel and measures blood flow in the vessel regardless of vessel size. The Quantix/OR simultaneously measures the internal diameter of the blood vessel and the velocity profile of the internal blood to calculate volume blood flow. Separately, Neoprobe reported the results of a clinical evaluation using its proprietary blood flow measurement technology published in the peer-reviewed journal Stroke. The article reported the clinical evaluation of patients at University of California at Los Angeles Medical Center, with the researchers testing the first generation of Neoprobe's Cardiosonix Quantix/ND system for the determination of blood flow volume in the internal carotid artery. The device is designed to allow neurosurgeons, vascular surgeons and intensive care unit or emergency room physicians to non-invasively assess global cerebral blood flow in real time. Quantix/ND consists of an ultrasound probe that obtains signals directly from the carotid artery in monitoring head trauma patients. In addition to neurosurgery applications, the Quantix/ND can be used to measure blood flow in vascular assessment applications such as femoral artery perfusion.
Onset Medical (Irvine, California) said the FDA has granted it clearance to begin marketing the Pathway Percutaneous Access device in the U.S. The initial clinical application for the Pathway device is the percutaneous nephrostomy procedure. By eliminating a number of surgical maneuvers, patient time in the operating room and expenses are reduced. The Pathway device is a new and different approach to percutaneous access technology. Thus far, early in vivo studies have shown that the Pathway Access Technology can allow the physician to achieve access to the different lobes of the kidney quicker, easier and with less trauma to the body than with conventional nonsurgical access approaches. Onset is performing a comparative clinical trial to prove the clinical superiority of the Pathway Access Technology vs. current, conventional access technology.
Orthovita (Malvern, Pennsylvania) has been granted a U.S. patent covering 14 separate claims related to the company's Aliquot Micro Delivery System, a catheter-based kit for the minimally invasive delivery of restorative materials used in bone repair, such as Orthovita's Cortoss Synthetic Cortical Bone Void Filler.
Proxima Therapeutics (Alpharetta, Georgia) said the first Canadian patient has been treated with its MammoSite Radiation Therapy System (RTS), under institutional review board protocol specified by both the Ville Marie Oncology Center and the Centre Hospitalier de l'Universite de Montreal (both Montreal, Quebec). With the speed of the five-day treatment, the patient was able to complete the therapy long before she would have begun traditional radiation treatments, which are administered daily for four to six weeks. MammoSite expands the range and flexibility of post-surgical treatment options for breast conservation therapy. For the appropriate patient, it delivers the prescribed dose of radiation directly to the site where tumors are most likely to recur. By internally delivering the radiation directly to the tissue surrounding the original tumor, the MammoSite RTS minimizes radiation exposure to healthy tissue, Proxima said.
QLT (Vancouver, British Columbia) said the FDA has granted fast-track review status to Visudyne therapy for both the occult with no classic and the minimally classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) patient populations. The company has completed patient enrollment in the pivotal Phase III trial of Visudyne therapy for the treatment of occult CNV due to AMD. QLT said it expects to have data available in the latter half of 2004. In addition, the first of 220 patients was initiated into the Visudyne Minimally Classic (VMC) trial. The VMC is a Phase III randomized, placebo- controlled, double-masked, multicenter clinical trial being conducted on patients with minimally classic CNV due to AMD. Visudyne therapy is developed and commercialized through the alliance of QLT and the ophthalmics business unit of Novartis Pharma AG (Basel, Switzerland).
Quinton Cardiology Systems (Bothell, Washington) said it has started shipping the new CardioVive AED under the Burdick (Deerfield, Wisconsin) brand name. The CardioVive AED provides continuous monitoring capabilities during and after resuscitation. The compact unit also features Rescue Ready technology, which performs daily automatic self-tests and monthly full-charge tests of its high voltage circuitry, to ensure that it is always ready for a rescue.
R2 Technology (Sunnyvale, California) has received FDA approval to market the ImageChecker DM computer-aided detection (CAD) system with OmniCAD technology. This technology provides an integrated solution to support CAD processing for both analog and digital mammography in a single Dual Mode unit, R2 said.
Trimedyne (Irvine, California) said it received FDA clearance to market its UroMAX Side-Firing Laser Needle for use with its Holmium lasers for the vaporization of tissues in urology; orthopedics; gynecology; ear, nose and throat surgery; gastrointestinal surgery; and general surgery. The new device is designed to enable a urologist to vaporize tissue of an enlarged prostate in about five minutes, which would make Trimedyne's procedure the shortest of any procedure for such application.
Vasca (Tewksbury, Massachusetts) reported that the U.S. Patent and Trademark Office has issued the company two additional patents in the field of dialysis access. Number 6,585,681, "Methods and Apparatus for Performing Flow-Through Peritoneal Dialysis," focuses on the use of the LifeSite technology for peritoneal dialysis and discloses an access technology that offers the potential for improved peritoneal dialysis delivery. Patent number 6,592,564, "Methods and Kits for Locking and Disinfecting Implanted Catheters," discloses the use of alcohol as a locking solution in catheters and the LifeSite System. The patents bring to 26 issued to the company in the U.S. Vasca says that the LifeSite Hemodialysis Access System "is the first totally subcutaneous hemodialysis access system commercially available to patients in the U.S."
Vascular Architects (San Jose, California) has received clearance from the FDA to market the aSpire Covered Stent and 718 Delivery System in the U.S. The device is cleared for use in treating tracheobronchial strictures. The aSpire Covered Stent provides greater lumen wall coverage than conventional metal stents, due to its spiral nitinol design which is covered with a thin layer of ePTFE, protecting the lumen from exposed metal, according to the company. The aSpire Covered Stent's spiral design delivers radial strength while preserving many of the native lumen's desired elements. The new 718 Delivery System separates stent apposition and deployment into two distinct steps, enabling precise deployment in a 7 Fr compatible system.
Ventracor (Sydney, Australia) said it has been issued two new patents. U.S. patent No. 6,609,883, titled "Rotary Pump with Hydrodynamically Suspended Impeller," includes features not previously claimed in earlier patents for its VentrAssist left ventricular assist system. The new U.S. patent relates to a hydrodynamically suspended impeller within a pump housing. In Australia, Ventracor has been granted Australian patent No. 760610, titled "A Rotary Blood Pump and Control System," by IPAustralia. The patent describes improvements to the VentrAssist and claims a new controller system specifically designed to work with VentrAssist.
Viatronix (Stony Brook, New York) has received FDA clearance for using V3D Explorer, its general-purpose 2-D/3-D medical imaging workstation, for X-ray modality data. The V3D Explorer workstation can process large and small radiology studies with precision and ease. A multi-purpose 2-D and 3-D viewing and post processing workstation, the V3D Explorer accepts DICOM-compliant images from several modalities, permitting radiologists to visualize patient's studies in any 2-D or 3-D projection for better understanding of anatomical relationships and pathological conditions. Separately, Viatronix said the company has received FDA clearance for using V3D Explorer, its general-purpose 2-D/3-D medical imaging workstation, for X-ray modality data. The V3D Explorer workstation can process large and small radiology studies with precision and ease. A multi-purpose 2-D and 3-D viewing and post processing workstation, the V3D Explorer accepts DICOM-compliant images from several modalities, permitting radiologists to visualize patient's studies in any 2-D or 3-D projection for better understanding of anatomical relationships and pathological conditions.
Vision-Sciences (Natick, Massachusetts) said that its Slide-On EndoSheath System, used in conjunction with flexible nasopharyngolaryngoscopes, has been found to be a cost-effective solution to enabling bedside endoscopic swallowing testing for dysphagia (swallowing disorders) in nursing home patients. The endoscopic swallowing test is an alternative to a modified barium swallowing study that can allow for a more lengthy evaluation as necessary. It eliminates the need for fluoroscopy or exposure to X-rays, and can be performed at the patient's bedside in any position.
WorldHeart (Ottawa, Ontario) said Health Canada has approved its submission to incorporate enhancements to its Novacor LVAS (left ventricular assist system). The refinements are intended primarily to enhance recipients' quality of life by having a quieter device and smaller, lighter, longer-lasting battery packs. These enhancements are commercially available in Europe and under review for approval in the U.S. by the FDA.
Zila (Phoenix, Arizona) has received approval for a U.S. patent covering the method by which its Zila Tolonium Chloride has been shown to detect pre-cancer and cancer cells. The patent is based upon in vitro studies of the Zila Tolonium Chloride mechanism of action. The U.S. Patent and Trademark Office has issued a notice of patent allowance for a method of detecting cancer by delivering an agent that is selectively retained by the mitochondria of pre-cancerous and cancerous epithelial cells. The patent claim is based on Zila Tolonium Chloride being retained by the increasingly negative mitochondria, identifying pre-cancer and cancer at its early stages.