Roche Diagnostics (Indianapolis) received FDA clearance last month for what the company says is the first and only natriuretic peptide test to be green-lighted by the FDA for risk assessment of cardiac events in people with stable coronary artery disease. The test is designed to run on Roche’s Elecsys systems and Modular Analytics E170 immunoassay analyzers.
“This additional application for use of NT-proBNP provides significant opportunities to help patients and their physicians learn more about their cardiac status and their cardiac risk,” said Mike Samoszuk, MD, chief medical officer of Roche Diagnostics, in a statement. “Millions of people in the U.S. have a high risk of developing cardiac events, because they have stable coronary artery disease.
He added: “Since this is an early marker of cardiac involvement in these disease processes, once a person is identified to be at cardiac risk, they can work with their physician to determine the best treatment and therapy early on. Laboratory tests like this are changing the way physicians approach patient care.”
A spokeswoman for Roche said that the FDA clearance was granted based on “three large studies with a total of 2,997 subjects.” Researchers measured proBNP levels and followed patients for a mean follow-up of five years. Ischemia is considered to cause the heart to release NT-proBNP, she said, thus providing an indicator of damage or other problems putting the individual at risk.
“After adjusting for other co-variables (age, gender, body mass index, lipids, etc.), Elecsys NT-proBNP remained a strong independent predictor of cardiovascular morbidity and mortality,” she said, including angina, heart attack and heart failure.
The proBNP test also is cleared as an aid in the diagnosis of individuals suspected of having congestive heart failure and as a marker of risk for patients with acute coronary syndrome and congestive heart failure, the company said.
Elsewhere in the product pipeline:
• American Bio Medica (Kinderhook, New York) said it has begun offering a point of collection drug screen that detects the presence or absence of buprenorphine in a urine specimen. Buprenorphine is a drug being used in a new office-based treatment for addiction to prescription pain relievers and other opiate drugs, including heroin. While the drug is intended to aid in addiction treatment, buprenorphine is potent (20 to 50 times the analgesic potency of morphine), has a long duration of action and does not need to be injected, therefore the potential for abuse is high, according to American Bio. The screening product is currently available to non-clinical markets, and the company said it plans to submit the screen for buprenorphine to the FDA for clinical marketing clearance.
• Angiotech Pharmaceuticals (Vancouver, British Columbia) reported last month that it has launched a U.S. pivotal study examining an anti-microbial central venous catheter (CVC). The study enrolled its first patient in Rapid City, South Dakota, and will involve about 600 patients at 20 centers in the U.S. The multi-center trial is designed to evaluate the efficacy of a CVC coated with the drug 5-Flourouracil (5-FU), a non-traditional anti-infective agent, to prevent bacterial colonization. One of the complications associated with CVC implantation is infection, which can occur when bacteria contaminate the surface of the cath-eter. The CVC trial is a randomized, single-blind, active-controlled, two-arm, multi-center clinical study. The lead trial site is the University of Massachusetts Memorial Medical Center (Worcester), with Stephen Heard, MD, as principal investigator.
• Applied NeuroSolutions (Vernon Hills, Illinois), which is developing products to diagnose and treat Alzheimer’s disease (AD) based on a novel hypothesis of AD pathology, said that according to a study soon to be published in Neurobiology of Aging an increase in a specific, abnormal brain protein appears to herald the onset of AD. The study noted a correlation between the increasing levels of the tau protein in the brain with a rise in the severity of dementia and cognitive impairment. This increased level of tau protein appeared prior to the development of neurofibrillary tangles, which are the hallmark lesions of Alzheimer’s disease. The study analyzed post-mortem brain tissue samples of 81 people, ranging from those with no indication of cognitive impairment to those diagnosed with AD. Applied NeuroSolutions is seeking to commercialize a diagnostic test to detect AD that measures the amount of an abnormal protein, p-tau 231.
• Arrow International (Reading, Pennsylvania) has introduced the maximal barrier precautions tray, a new central venous catheter (CVC) insertion kit. The tray, available in 10 different configurations, provides a comprehensive array of tools to prevent central line infections. Patient protection components of the tray include an insertion checklist to help healthcare workers comply with all relevant guidelines, a ChloraPrep Applicator for preparing the insertion site, a 68” by 110” full body drape, and catheters that feature ARROWg+ard antimicrobial technology, which features a combination of silver sulfadiazine and chlorhexidine impregnated into the catheter surface.
• ArthroCare (Austin, Texas) said study results released at the recent International Cartilage Repair Society 6th Symposium show the use of low-temperature bipolar radio frequency, ArthroCare’s Coblation technology, may aid in the repair of the avascular region of the meniscus of rabbits following injury and suture repair. During the study, 20 New Zealand White rabbits with meniscal injuries in the avascular region had suture repair while 26 were treated with suture repair and Coblation technology. No evidence of healing was observed in the suture-only menisci. However, 54% of the menisci treated with Coblation in addition to suture repair showed some evidence of healing after nine days. When given 28 days, it resulted in a 70% healing rate.
• Baxter Healthcare (Deerfield, Illinois) said it has received marketing clearance from the FDA for the TricOs T Bone Void Filler, indicated for voids or gaps in bone that are not intrinsic to the stability of the bony structure, including bone defects from surgery or traumatic injury. The clearance of TricOs T represents the company’s first commercially available orthobiologic product in the U.S. TricOs T is a combination of hydroxyapatite-coated beta tricalcium phosphate granules and a fibrin matrix based on Baxter’s Tisseel VH fibrin sealant contained in one convenient kit. TricOs T provides a 3-D osteoconductive environment for the formation of new bone. The product also is biocompatible, allowing it to be resorbed by the body over time. The company expects full market availability for the product in the U.S. to occur in the second half of 2006.
• BD Diagnostics (Baltimore) reported that the FDA has granted clearance for a robotic system called the BD Viper System that can essentially mimic the laboratory movements of a lab technologist for in vitro infectious disease molecular diagnostic testing. BD (Franklin Lakes, New Jersey), said the BD Viper System is an approach to laboratory automation using an industrial class of robotics known as Selective Compliance Assembly Robot Arm (SCARA). That classification indicates that the robot is multi-jointed, similar to the human arm, the company said. Ric Hughen, director of marketing for molecular diagnostics for BD, said that the system “attacks lab automation from a pick-and-place standpoint similar to what a technologist does with a hand pipetter.” He added: “They pick something up with a pipetter and they move it to another location and dispense it, and you’ve not been able to do that historically, because the equipment was either inaccurate or unreliable or both.” The reason such “1950s-type technology” was unreliable was because it relied on pumps, reagent tubing and syringes – all components that are eliminated with the Viper system. The BD Viper System automates previously manual and semi-automated steps of the BD ProbeTec System, first marketed in 1998, which is the only commercially available real-time DNA amplification assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Viper also is approved for Legionella, another pathogen. “Incubations, amplification and detection all occur on the BD Viper System, with repetitive pipetting labor delegated to the robot,” the company said.
• Biosite (San Diego) reported submitting a 510(k) premarket notification with the FDA for diagnostic tests for myeloperoxidase (MPO), a biomarker of inflammation in the walls of coronary arteries. Biosite said it plans to offer a single Triage MPO Test and a second generation Triage Cardio ProfilER Panel that will include MPO. The company said it believes the addition of MPO to the Triage Cardio ProfilER Panel can advance the diagnostic and prognostic utility of the product, used for emergency assessment of chest pain patients. The panel currently measures the levels of troponin and its complexes, along with CK-MB, BNP and myoglobin in blood and is used as an aid in the diagnosis of myocardial infarction, diagnosis and assessment of severity of congestive heart failure and risk stratification of patients with acute coronary syndromes.
• BioSphere Medical (Rockland, Massachusetts), a pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations, reported that its embolic delivery system products, EmboCath Infusion Catheter and Segway Guidewire, were approved by the Medical Device Department of the State Food and Drug Administration of the People’s Republic of China for clinical use in embolization procedures. In China, BioSphere plans to sell both its delivery system products and the company’s Embosphere Microspheres for embolization procedures. The use of Embosphere Microspheres for embolization is currently under review by the Chinese regulatory authorities based on a clinical trial using Embosphere Microspheres in a treatment protocol for patients with primary liver cancer. The company said it expects market clearance for the use of Embosphere Microspheres in China during the first half of 2006.
• BioSyntech (Laval, Quebec) said that its BST-CarGel was the subject of a study published in the December 2005 issue of the Journal of Bone and Joint Surgery. The study describes the ability of BST-CarGel to repair damaged cartilage in the knees of sheep. According to the study authors, BST-CarGel demonstrated statistically superior cartilage repair compared to the control. BST-CarGel is currently being tested in a multi-center, randomized clinical trial being carried out in Canada.
• CAS Medical Systems (Branford, Connecticut) said the FDA has cleared for marketing its new Model 750E Series Monitor. Coming just six months after the launch of the 750C Monitor, the 750E incorporates either 3- or 5-lead ECG with impedance respiration along with the company’s MAXNIBP (Motion Artifact Extraction) non-invasive blood pressure technology, a choice of Masimo (Irvine, California) SET Pulse Oximetry or Nellcor (Pleasanton, California) OxiMax Pulse Oximetry, and Oridion Systems (Jerusalem, Israel) Microstream Capnography. The company said it plans to launch the product within the first quarter of 2006.
• CryoCor (San Diego), focused on the treatment of cardiac arrhythmias, reported an update to the status of its atrial flutter premarket approval (PMA) application with the FDA. The FDA has recently notified the company that it continues to actively review its PMA following the submission of additional data in October. The company’s current expectation is that it remains on its original timeline in seeking approval from the FDA to market its Cardiac Cryoablation System in the U.S. for the indication of atrial flutter. The Cardiac Cryoablation System is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue.
• CryoLife (Atlanta), a biomaterials and biosurgical device company, reported that it has received FDA approval for a new 10ml disposable syringe for BioGlue Surgical Adhesive. The 10 ml BioGlue Syringe provides surgeons with an effective adhesive in an easy-to-use, self-contained, disposable syringe, ideally suited for complex cardiovascular surgery procedures. Currently available in Europe, the 10ml BioGlue Syringe will be introduced to the U.S. market late in 1Q06. The BioGlue Syringe already is available in the U.S. in 2 ml and 5 ml volumes. BioGlue is a two-component adhesive that creates a flexible, mechanical seal, independent of the body’s clotting mechanism, within 20 to 30 seconds, and reaches its maximum bonding strength in two to three minutes.
• FlowCardia (Sunnyvale, California), a manufacturer of recanalization systems to treat chronic total occlusions (CTOs), reported FDA 510(k) clearance and market release of the VP Wire and VP Sheath Product families. The VP Wire and VP Sheath are designed to facilitate the introduction and navigation of balloon catheters and other interventional devices in PTA and PTCA procedures. The supportive 0.014” VP Wire will be available in 165 cm and 300 cm lengths in a soft and standard platform. The VP Sheath is a thin-walled 6 Fr catheter introduced through any 8 Fr guide catheter or sheath creating an extended, supportive pathway for interventional devices. FlowCardia also reported that more than 80 of the required 125 patients have been enrolled in the pivotal phase of the FACTOR Trial, the company’s U.S. clinical trial for the Crosser CTO Recanalization System. The Crosser System uses high frequency mechanical vibration to quickly cross CTOs, allowing subsequent balloon angioplasty and stent placement. The company said it expects to complete pivotal phase enrollment in 2Q06.
• Ingen Technologies (Calimesa, California), which markets OxyAlert and Secure Balance, reported that its newest product, OxyView, is complete and will be ready to be sold to medical markets worldwide in February. OxyView is a lightweight pneumatic gauge that provides visual safety warning of oxygen flow to hospitalized patients. The device is attached to the oxygen tubing just below the neck and informs the nursing staff of oxygen flow rate near the patient.
• Intelligent Medical Implants (IMI; Zug, Switzerland), a neuro-prosthetics device company, reported that its first-generation Learning Retinal Implant System, containing a 50-electrode device, has been successfully implanted in two patients. The company said clinical testing will begin on schedule this month, and said it remains on schedule to initiate a pivotal clinical trial this year with its 231-electrode Learning Retinal Implant. The Learning Retinal Implant System replaces the signal-processing functions of a healthy retina and provides input to the retinal nerve cells that, in turn, provide input to the optic nerve and the brain. In a previous multi-site European clinical study performed with a single electrode, researchers reported that 19 of 20 totally blind persons (95%) were able to see a small point of light.
• Inverness Medical Innovations (Waltham, Massachusetts) reported receiving FDA 510(k) clearance to market its Albumin Cobalt Binding test for detection of Ischemia Modified Albumin (IMA) on the Roche Diagnostics (Indianapolis) Cobas Integra 700 and Cobas Integra 800 chemistry analyzer systems. Shipments on those platforms will begin during 1Q06. When used in conjunction with electrocardiogram and cardiac troponin tests, IMA assists in the early evaluation of acute coronary syndromes in patients presenting to hospital emergency departments with chest pain.
• Kensey Nash (Exton, Pennsylvania), a manufacturer of absorbable biomaterials-based products, said it submitted an application to the FDA for 510(k) clearance for its ThromCat Thrombectomy Catheter System, a thrombectomy catheter used to remove thrombus or blood clots from a patient, with an initial indication for use in AV grafts and fistulas. The company said it plans to study use of the device in additional vessels this year. The disposable catheter system incorporates HeliFlex technology, an internal rotating helix that creates a vacuum to draw thrombus into the catheter and macerate it, while simultaneously flushing to aid in its removal. The ThromCat System will be sold through Kensey Nash’s direct U.S. endovascular sales force.
• Medical Carbon Research Institute (MCRI; Austin, Texas), has instituted a new study it hopes will show that its On-X Prosthethic Heart Valve will enable a significantly reduced amount of anticoagulation drug therapy. MCRI reported FDA approval of the Reduced Anticoagulation Clinical Trial of the On-X Prosthetic Heart Valve trial and internal review board okay. Clyde Baker, president of MCRI, said pursuit of this kind of study is a “natural progression” for use of the On-X, based on 10 years of implant experience since its early-90s approval, the data from these uses and a variety of usage circumstances, including “confirmatory” trials. The company reports more than 40,000 On-X valves implanted since 1996. The trial will enroll 1,200 patients, focusing on three groups of disease severity: low-risk aortic valve replacement patients, higher risk aortic valve replacement patients and mitral valve replacement patients. (Higher risk patients those with heart rhythm problems, left ventricular dysfunction, previous thrombo-embolism and condition of hypercoagulability.)
• Medical Tactile (Los Angeles) has launched the SureTouch Visual Mapping System, a sensing device currently cleared only for documentation of clinical breast exam results, but that in about a year CEO Steve Weiss hopes ultimately will be FDA-approved for diagnostic screening of breast lesions. “I don’t know for sure, because it’s up to the FDA when they review our request, but it could take probably in excess of a year [to get a PMA},” Weiss said. He said he expects the FDA to require the Medical Tactile to conduct clinical trials involving between 500 and 1,000 women. Based on the company’s tactile sensing technology, the SureTouch Visual Mapping System uses sensors that are designed to detect lesions as small as 5 mm to improve the sensitivity, specificity and objectivity of manual breast palpation exams. The company said that such exams are the “most accessible first line of defense” against breast cancer for most women. Medical Tactile was founded in 2002 on the basis of the SureTouch breast palpation technology, which was developed at Harvard University (Cambridge, Massachusetts) by Jae Son, PhD, the firm’s chief technology officer.
• Mediscience Technology (Cherry Hill, New Jersey) reported filing an investigational device exemption application with the FDA’s Center for Devices and Radiological Health. The filing is subject to evaluation by the FDA to determine when a proposed human clinical pilot study of the company’s cervical cancer detection radiometer may begin. The clinical objectives are to demonstrate the device’s ability to distinguish between tissues that are normal, benign, precancerous low grade, precancerous high grade and cancerous. The results will be compared to the PAP test and tissue biopsy and will be evaluated for clinical adverse events. The pilot study will enroll 400 patients in a multi-center trial of sensitivity and specificity of the company’s precancer/cancer detection ratiometer device. Two groups of 50 to 75 patients each will be tested to define the spectral characteristics of the normal and cancerous cervix. The remaining population will be tested to define intermediary states between normal and various stages of cancer.
• Micrus Endovascular (Sunnyvale, California) reported market launch of its .018-inch-diameter microcoil, Cerecyte 18, which expands the company’s Cerecyte product line to include additional microcoils that enable the treatment of large cerebral aneurysms. Cerecyte 18 incorporates the same bioactive technology used in the company’s other Cerecyte microcoils, which independent researchers suggest may improve outcomes, as presented at the 8th Congress of the World Federation of Interventional and Therapeutic Neuroradiology. Micrus manufactures both implantable and disposable medical devices used in the treatment of cerebral vascular diseases.
• Nanogen (San Diego) said it has expanded its molecular reagent product portfolio to include two new products to detect sequences for respiratory viral pathogens: a multiplex solid-phase hybridization set of reagents that can be employed to develop and validate assays for the detection of the sequences of six human respiratory viruses prevalent during flu season; and a research-use-only (RUO) real-time PCR probe and primer set for the identification of the influenza A and B viruses. The NGEN RVA analyte specific reagent (ASR) product can be used to develop and validate assays to detect the sequences of and differentiates among influenza A and B, respiratory syncytial virus and parainfluenza 1, 2 and 3. Assays validated using NGEN RVA ASR can be carried out with various sample types, and, once validated by the laboratory, can be used as a clinical diagnostic test. The product was developed in cooperation with Prodesse (Waukesha, Wisconsin), a supplier of molecular-based reagents for infectious disease targets, and is available in the U.S. as an ASR for which analytical and performance characteristics are not established.
• Novare Surgical Systems (Cupertino, California) said it is targeting its newly introduced line of EndoLink articulating surgical instruments for total laparoscopic hysterectomy (TLH), the newest, most advanced approach for removing the cervix and uterus employing minimally invasive “keyhole” surgery. The FDA-cleared, single-use, hand-held surgical instruments are the first to provide surgeons with six degrees of freedom not available with conventional, rigid instruments for performing laparoscopic procedures, without the need for computer-aided instruments or robotics. EndoLink instruments articulate with wrist-like left/right and up/down movements inside the closed surgical field, thereby allowing surgeons to use the full spectrum of their traditional open surgery skills for laparoscopic operations.
• Osteotech (Eatontown, New Jersey) reported that the FDA has cleared the company’s fifth 510(k) submission for its family of DBM products. This 510(k) submission, which covers Osteotech’s Grafton DBM Gel, Putty, Flex, Matrix and Crunch, cleared these tissue forms for use in dental, oral and cranio/maxillofacial procedures. In these procedures, Grafton DBM is intended to be used to fill and/or augment bone defects that may be surgically created or created by traumatic injury to the bone. Grafton DBM is an osteoinductive and osteoconductive, demineralized bone product that is uded for bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure and is remodeled and replaced by host bone during the healing process.
• ProRhythm (Ronkonkoma, New York) reported conditional approval by the FDA allowing the company to proceed into the pivotal phase of the investigational device exemption trial for the treatment of symptomatic, paroxysmal atrial fibrillation (AF) using its HIFU (high-intensity focused ultrasound) Ablation System. The pivotal trial, known as “focusAF,” will involve U.S. cardiac electrophysiology centers that specialize in the treatment of AF. Enrollment in the trial is expected to begin in 1Q06.
• ReGen Biologics (Franklin Lakes, New Jersey) reported that it has decided to change course, electing to pursue an FDA 510(k) application for its collagen scaffold device – called CMI – instead of the more rigorous and costly premarket application (PMA) pathway it previously indicated it would follow and for which it had, in fact, been conducting a clinical trial. The company said the 510(k) clearance would allow it to more quickly advance to the market in the U.S. its family of collagen scaffold products, including an application of the ReGen collagen scaffold for the meniscus – a crescent-shaped cartilage pad on the tibial plateau of the knee. The company said that predicate devices, including surgical patches were recently cleared, including two in 2005. ReGen said it believes the CMI targets a large portion of the estimated 860,000 partial meniscectomies procedures in the U.S. – a meniscectomy being a procedure in which the torn or damaged tissue is removed. The company said it believes CNI provides an alternative solution that addresses the problems cause by a loss of tissue, such as osteoarthritis of the knee.
• Smith & Nephew Orthopaedics (Memphis, Tennessee) reported the launch of the Legion Revision Knee System, featuring the company’s oxidized zirconium alloy material, Oxinium. The Legion Revision Knee System is designed for revision knee procedures, and offers the potential for reduced operating time, as well as the additional durability of Oxinium. The Legion system’s Oxinium component – the only revision implant option on the market that addresses the metal-sensitive patient – offers maximum biocompatibility and the potential for better performance in a revision environment, the company said. Smith & Nephew Orthopaedics also reported the launch of the Trigen Hindfoot Fusion Nail (HFN), the most recent addition to the Trigen Intramedullary Nail System. The Trigen HFN is indicated for degeneration, deformity or trauma of the hindfoot, as well as failed total ankle replacement and failed ankle arthrodesis. The Trigen Hindfoot Fusion Nail is inserted through the heel to keep the ankle in correct position and allow the bones to fuse into a solid structure. This minimally invasive technique was designed to reduce blood loss and patient exposure to blood-born pathogens. As with other implants in the Trigen Nail System, the Trigen HFN offers simplified instrumentation to reduce the amount of time and space required in the operating room.
• Smiths Medical MD (St. Paul, Minnesota) reported that it has received FDA 510(k) clearance for its new CADD-MS 3 Ambulatory Infusion Pump for micro infusion therapies. Based on the Deltec Cozmo insulin pump platform, the small, lightweight CADD-MS 3 ambulatory infusion pump features multiple programming options for a broad application of micro infusion therapies, security pass codes for set up and programming, and programming menus that the company said are easy to use and follow. The CADD-MS 3 pump is indicated for IV, subcutaneous, epidural and intrathecal routes of delivery for therapies requiring small doses of medication.
• Spacelabs Medical (Issaquah, Washington), a provider of patient monitoring systems, reported the availability of a wireless networking option for its UltraviewSL compact monitors that is capable of operating on a hospital’ existing wireless infrastructure while coexisting with other wireless applications. Spacelabs is initially launching its wireless connectivity solution in the U.S. and Canada; worldwide distribution is planned for early 2006. The UltraviewSL 2400 wireless monitor is compliant with 802.11b, the WiFi standard that has gained acceptance within healthcare institutions worldwide. Spacelabs also is introducing a field upgrade kit to enable existing UltraviewSL compact monitors to operate in a wireless environment. The new monitor has full network compatibility with all existing Spacelabs UltraviewSL, Ultraview and PCMS centrals and bedside monitors.
• SpectraScience (Minneapolis) reported that it has received notification from the European Patent Office that a patent will be issued for its “Optical Biopsy Forceps and Method of Diagnosing Tissue.” The company has developed its WavStat Optical Biopsy System for use by physicians in diagnosing tissue to be normal, pre-cancerous or cancerous. The WavStat System is currently approved by the FDA for use in detecting cancer in the colon. Other applications are being test
• SpectRx (Norcross, Georgia) reported that it has built and successfully tested its first pre-production, non-invasive cervical cancer detection device, a device that, if approved, could immediately shift a market long dependent on Pap testing. The device, which was developed in part by SpectRx, identifies cancers non-invasively by analyzing light reflected from the cervix. The instrument contains “major components” planned for use in commercial production and will be used to complete the ongoing FDA pivotal clinical trial necessary for regulatory approval. Begun in March 2004, the pivotal trial has used an “alpha” prototype device. “Completion of this beta device, and single-patient-use disposables, is a major milestone in the process of bringing this unique technology to market,” said Mark Faupel, president and chief operating officer of Guided Therapeutics, a company spun off from SpectRx to commercialize its cervical cancer detection device, in a statement. “We are pleased with the initial technical performance of the pre-production device and single-use disposable, both of which will benefit from advances in our patented technology and component optimization.” He also said that Guided Therapeutics expects to place the first new device in the pivotal clinical trial early this year. “These new devices will allow us to close out the human data collection phase of the FDA trial and begin preparation of the important clinical data section of the premarket approval,” Faupel said.
• ThermoGenesis (Rancho Cordova, California), a developer of enabling technologies for cell therapeutics, said the FDA’s Center for Biologics Evaluation and Research notified the company that it was reviewing the company’s premarket application (PMA) for CryoSeal FS. The PMA submission was based on clinical results from a Phase III trial evaluating the safety and efficacy of CryoSeal FS as an adjunct to hemostasis in liver resection surgery against a control, Instat, a collagen absorbable hemostat. The multi-center randomized and blinded clinical trial of 150 cancer patients showed that CryoSeal FS demonstrated superiority to the Instat control by causing statistically significant quicker time to hemostasis vs. the control group. If approved, CryoSeal would be the only fibrin sealant produced from the patient’s own blood on the market and an alternative to conventional fibrin sealants derived from bovine tissue and pooled human bloods which currently are used in a wide range of surgeries.
• TyRx Pharma (Monmouth Junction, New Jersey), a developer of combination medical devices and drug delivery products using tyrosine-derived polyarylate polymers, said that the FDA granted 510(k) clearance for its new bioresorbable polymer-coated surgical mesh product. TyRx expects to launch this new surgical mesh in 1Q06. The TyRx bioresorbable polymer surgical mesh is indicated for the repair of hernias and other abdominal fascial or muscular deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result.
• Trimedyne (Irvine, California), a maker of lasers and fiber optic devices for minimally invasive surgery, reported receiving FDA clearance for its new VaporMAX Fiber for use with the company’s Holmium Lasers for its FDA-cleared indications, including the treatment of enlarged prostates. The clearance also covers marketing the VaporMAX Fiber for use with Holmium Lasers with a compatible connector made by others. Trimedyne’s VaporMAX Side-Firing Laser Fibers vaporize an average of 3 grams of soft tissue per minute over 60 minutes of use, which is faster than other currently marketed laser devices, based on laboratory testing of animal tissue and published data, the company said.
• Wright Medical Group (Arlington, Tennessee) reported the launch of its wear-reducing A-Class Polyethylene Liner for the Lineage Acetabular Hip System. Recently granted marketing clearance by the FDA, Wright’s A-Class Polyethylene Liner is produced with a proprietary crosslinking process, reducing the potential for dissolution of adjacent bone due to osteolysis. Laboratory testing has shown that the A-Class Polyethylene Liner reduces the generation of wear debris by up to 94% when compared with current Lineage polyethylene liners.
• Xoft (Fremont, California), a developer of new technologies for the practice of radiation oncology through electronic brachytherapy, which uses proprietary miniaturized X-ray tube technology, reported that it has received clearance from the FDA for the Axxent Electronic Brachytherapy System for the treatment of breast cancer. The Axxent system uses disposable micro-miniature X-ray radiation sources to deliver ionizing radiation treatment directly to tumor beds. In its first indication for use, the Axxent system can be used to deliver a course of radiation therapy for early-stage breast cancer. The company said it gives radiation oncologists the flexibility to deliver radiation at multiple energy levels, while at the same time eliminating the need for heavily shielded environments so that it can be used in a broader range of clinical settings. As a platform technology, the Axxent Electronic Brachytherapy System is designed to address a variety of oncological and non-oncological indications.
• Xtent (Menlo Park, California), developer of what it calls next-generation “customized” DES technology, last month reported the first procedures in its CUSTOM II trial that is examining the ability of its system to do multi-vessel stenting and long lesion stenting as an alternative to the use of multiple stents. Key to this system is the use of a single stent train capable of deploying the DES into multiple placements or into long lesions without using several stents or several stents in overlapping fashion. Xtent reported that for the first time “in the history of coronary stenting,” a single catheter was used to treat multiple lesions in multiple coronary arteries in a human patient. The company further announced that physicians have treated a second patient with “the longest coronary stent of any kind ever delivered with a single catheter.” The procedures were performed by Eberhard Grube, MD, chief of cardiology at Siegburg Heart Center (Siegburg, Germany) and principal investigator for Xtent's CUSTOM II clinical trial.