With the market introduction of a new plate used for cervical spine fusions, surgeons and patients in the U.S. now will have the choice of a new resorbable biological material, a feature not found in traditional metal implants. The device, called the Mystique resorb- able graft containment system, is made by the Medtronic Sofamor Danek (Memphis, Tennessee) unit of Medtronic (Minneapolis).
The company said the Mystique plate is the first implant of its kind for spinal surgery. When surgery is needed to alleviate nerve or spinal cord compression, a surgeon may perform a procedure called an anterior cervical discectomy and fusion. In this procedure the surgeon makes a small incision in the front of the neck to reach the cervical spine. The disc is removed and the space is filled with bone graft.
The Mystique plate is used for stabilizing the weak bony tissue around the fusion, preventing bone graft dislodgement and facilitating healing. The new plate is flexible and made of material that dissolves in the body within 18 to 36 months after implantation. The device is made of Hydrosorb PLDLA co-polymer. This co-polymer consists of 70% Poly (L-lactide) and 30% Poly (D,L-lactide).
“The implant itself was developed and designed with a key supplier of ours, Macropore Biosurgery [San Diego], said Jeff Urbany, director of marketing for Medtronic Sofamor Danek’s cervical stabilization business. He told The BBI Newsletter that Medtronic has an exclusive distribution agreement with Macropore for use of this particular Hydrosorb material for spinal applications. “We co-developed the design of the implant the screws [and] the instruments in conjunction with Macropore,” he said. “It’s their recipe, but we’ve taken that recipe and applied it to spine surgery.”
Macropore recently changed its name to Cytori Therapeutics, but as part of the reorganization re-tained the name Macropore Biosurgery for the division of the company that manufactures the Hydrosorb family of FDA-cleared bioresorbable implants.
More than 10 years of clinical experience and research have shown that implants manufactured from PLDLA materials provide clinicians with a higher level of surgical versatility, the company said. “This material has been used in the body for quite some time,” said Urbany, including in craniofacial surgery and in some other orthopedic applications
Elsewhere in the product pipeline:
• ArthroCare (Austin, Texas), a company developing minimally invasive surgical products, reported receiving FDA clearance for its Parallax Acrylic Resin with Tracers-Ta Bone Cement Opacifier for applications in the fixation of fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions and malignant les-ions, with an estimated 750,000 people a year diagnosed with vertebral compression fractures. Parallax Acrylic Resin with Tracers-Ta Bone Cement Opacifier, designed to enhance the ability to track the flow of bone cement under fluoroscopy, consists of pre-measured polymethyl-methacrylate, barium sulfate and proprietary tantalum disk opacifiers. These particles create visible dark dots that clearly show cement flow and placement within the bone cavity, increasing patient and procedure safety.
• Beckman Coulter (Fullerton, California) has laun- ched its Integrated Cytometry Solution (ICS), which combines the company’s FC 500 flow cytometer with the new FP 1000 sample processing system. The company said the new solution, now being shipped to its customers, is the first integrated system to offer laboratory information system (LIS) connectivity. Suited for high-volume clinical reference laboratories, ICS stream- lines workflow and tracks samples throughout the testing process, Beckman Coulter said, from receipt and preparation, to acquisition and analysis of data, to reporting results. It said that approach helps laboratories standardize their flow cytometry testing processes, resulting in an increase in efficiency, accuracy and operator safety. The company said flow cytometry is widely used to provide automated analysis of various blood cell populations. It is commonly used in in vitro diagnostics to identify and enumerate certain cell populations that are key indicators of diseases, including HIV, leukemia and lymphoma.
• Biosite (San Diego) reported that the FDA has granted a Clinical Laboratory Improvements Amendment (CLIA) waiver for its Triage BNP test, which it said would result in “substantially expanding” physicians’ access to the test, designed for the diagnosis and assessment of patients with symptoms of heart failure. The Triage BNP Test is a rapid immunoassay blood test that aids in the diagnosis of congestive heart failure, assessment of disease severity and in the risk stratification of patients with acute coronary syndromes. Biosite said the CLIA waiver would expand access to the test among physicians’ offices and decentralized hospital sites of service, allowing more patients to benefit from the 15-minute blood test. “This is a significant competitive advantage for us,” said Biosite Chairman and CEO Kim Blickenstaff, adding that it is “significant reduction of barriers.” He noted that there are no other companies with CLIA waiver for the BNP test.
• Biotronik (Lake Oswego, Oregon) reported that the first U.S. implantation of its Lumos DR-T implantable cardioverter defibrillator (ICD) was performed at Loyola University Medical Center (Chicago) by Niraj Varma MD, director of cardiac electrophysiology laboratories at Loyola. The Lumos defibrillator was recently approved by the FDA. Biotronik said it is the first ICD that automatically transmits intracardiac electrograms (IEGMs) via radio frequency (RF) communications and allows the physician to view that vital patient information on a secure web site at any time, from anywhere. The IEGM provides beat-by-beat heart rhythm information similar to that of a surface ECG. The company has incorporated that data into its Home Monitoring communications technology. In the instance of a cardiac event such as a ventricular arrhythmia, the wireless system incorporated in the Lumos ICD will automatically and transmit the record to the physician’s office without any patient involvement required. Biotronik’s Home Monitoring system provides automatic, instantaneous transmission of data from both pacemakers and defibrillators to the physician at the time of a cardiac event or change in the implant status.
• CardioTech International (Wilmington, Massachusetts) reported that its wholly owned subsidiary, Gish Biomedical (Rancho Santa Margarita, California), has received FDA clearance for its auto transfusion and cardiotomy reservoir products with GBS (Gish Biocompatible Surface) Coating for the cardiopulmonary surgery market. The GBS Coating is a covalently bonded heparin-based coating composed of heparin and hyaluronic acid, or hyaluronan. Hyaluronan is a hydrophilic biopolymer that occurs naturally in the human body.
• Celera Genomics (Alameda, California) published what it called novel findings linking genetic variations in four genes with an increased risk for myocardial infarction (MI), or heart attack. None of these gene variants have previously been associated with MI, and they could lead to the identification of new coronary heart disease (CHD) mechanisms. The paper will appear in the October issue of the American Journal of Human Genetics. Celera Diagnostics, a joint venture between the Applied Biosystems Group and Celera Genomics Group of Applera, conducted the study in collaboration with researchers at Quest Diagnostics (Lyndhurst, New Jersey), the Cleveland Clinic Foundation and the University of California, San Francisco. Celera Diagnostics evaluated DNA samples from more than 3,000 individuals in three studies to compare patterns of genetic variation in people with a history of MI to those with no history of CHD. The results were replicated in all three studies.
• Cook (Bloomington, Indiana) said it would launch the Zenith Renu abdominal aortic aneurysm (AAA) ancillary graft – calling it an “industry-unique device” – following receipt of FDA approval. The company said the Zenith Renu is the “first device for secondary endovascular intervention in the U.S.” Cook said the device is the first designed specifically for secondary endovascular intervention in patients who have received prior endovascular repair of infrarenal abdominal aortic aneurysms. The Zenith Renu device is available in two configurations, a main body extension and a converter. Cook also said that all of its polyurethane Turbo-Flo Peripherally Inserted Central Venous Catheters (PICC) have received clearance from the FDA to be marketed for use with power injectors for delivery of contrast media in computed tomography (CT) studies. The company said the new indication means hospitals can eliminate the need to stock two kinds of PICC lines.
• CryoCor (San Diego) reported that it has been notified that the FDA has completed its initial review of the company’s atrial flutter premarket approval (PMA) application and is entering the next phase of its review. The company submitted the final module of its PMA in July, that containing the clinical safety and efficacy data from a 160-patient U.S. clinical trial. The company’s goal is to receive FDA approval in 2006.
• Cybernet Medical (Ann Arbor, Michigan), a developer of electronic recordkeeping and biometric monitoring technology supporting outpatient care, reported receiving U.S. patent 6,875,174, which with three other U.S. patents covers broad implementation of the MedStar Internet and telephone-based telemedical products and the web-based electronic medical record services that support them. The MedStar system integrates secure web-based electronic patient records, interactive voice response, patient activity log and vital signs measurement that supports management of hypertension, cardiac diagnostics, congestive heart failure, diabetes, COPD, asthma and wound care management.
• Cytyc (Marlborough, Massachusetts) reported that the FDA has approved a premarket approval supplement for the ThinPrep Pap Test related to the detection of endocervical and endometrial glandular lesions. The enhanced labeling cites multiple peer-reviewed publications that report on the improved ability of the ThinPrep System to detect glandular disease vs. the conventional Pap smear. The labeling further states that the results of these studies are consistent in showing more frequent biopsy confirmation of abnormal glandular findings by ThinPrep technology compared to conventional cytology. The ThinPrep Pap Test is the only cervical cancer screening technology to gain expanded labeling claims related to the detection of glandular abnormalities. According to the company, the ThinPrep Pap Test is currently the most widely used method for cervical cancer screening in the U.S. and also is the only liquid-based cytology approved by the FDA for HPV testing and the only cytology system approved by the FDA for chlamydia and gonorrhea testing directly from the ThinPrep collection vial.
• Given Imaging (Yokneam, Israel) has introduced Rapid 4, which it said is the most advanced version of its Rapid software for use with the PillCam Platform. The company said Rapid 4 offers new physician-friendly features and diagnostic tools making it easier to read and interpret the videos captured from the PillCam SB and PillCam ESO video capsules. The new features include QuickView, which allows the physician to perform a fast, sequential and intelligent preview of suspicious images when present in the video stream as well as their location in the video prior to performing a full reading; Rapid Atlas, which allows the physician to quickly compare the on-screen video image with known small bowel and esophageal reference images stored in the database; Automatic Viewing Mode, which provides an aid for more efficient diagnostic review through a smoother image transition, making review of a video more comfortable for the reader; and Circumference Scale, a tool to help estimate circumferential involvement of a finding detected by PillCam ESO or PillCam SB such as an esophageal varix or a small-bowel ulcer. Rapid 4 has not yet been cleared for sale in the U.S.
• Guidant (Indianapolis) reported that the FDA has approved its Contak REnewal 3 RF cardiac resynchronization therapy defibrillator (CRT-D) for heart failure patients and the Zoom Latitude programmer. The Renewal 3 RF CRT-D is Guidant’s first wandless cardiac resynchronization therapy device. The Zoom Latitude programmer is a next generation programmer designed to interface with devices that include remote monitoring capability, such as the Renewal 3 RF, as well as the current global implant base of Guidant devices. This wireless system is designed to save physicians and patients time during implant and at follow-up, with device interrogations that can be three times faster than Guidant’s previous programmer. Guidant plans to introduce these products in the U.S. during 4Q05. The company said that both devices are the cornerstones of the Latitude Patient Management system. The anticipated advantages of this system include speed, convenience and patient care.
• Inovio Biomedical (San Diego) reported that a presentation highlighting the applicability of its MedPulser selective electrochemical tumor ablation system to treat melanoma took place at the 6th World Congress on Melanoma in Vancouver, British Columbia. Inovio is commercializing a cancer therapy that uses its MedPulser selective electrochemical tumor ablation system in conjunction with Bleomycin, an approved anti-cancer drug, to locally treat solid tumors. The presentation concludes: “Treatment with electroporation with intralesionally administered Bleomycin appears to have been an effective and practical therapy option for our patient and potentially for cutaneous and subcutaneous tumors in general. Electroporation is reported to be an effective therapeutic tool for a number of tumor types, e.g. epithelial, non-epithelial and metastases or primary tumors of the skin.” The therapy is currently under evaluation in a multi-center trial in Germany, the Netherlands, Sweden, and the UK, Inovio said.
• IntraLase (Irvine, California), a manufacture of ultra-fast lasers, related software and disposable devices used to create a corneal flap, the first step in LASIK surgery for the correction of vision, said it has received a new 510(k) clearance from the FDA for use of the IntraLase FS30 femtosecond laser in creating the corneal resections performed in lamellar keratoplasty and penetrating keratoplasty procedures. The IntraLase FS30 laser is the first and only laser to receive clearance for use in penetrating keratoplasty, the company said. The clearance allows use of the IntraLase FS30 laser to create deep corneal incisions and the full-thickness resections required for penetrating keratoplasty.
• Invacare (Elyria, Ohio) has introduced the HomeFill II, a portable oxygen system that allows patients on oxygen therapy to fill their own oxygen cylinders at home without waiting for deliveries. “[Traditionally], the home care provider will put the oxygen concentrator in the patient’s home, and then they will typically deliver cylinders, let’s say once a week, because if I go out for four hours in the day I might use up one of those cylinders, so I may use up to seven, eight, 10 cylinders in a week,” said John Ledek, vice president of Invacare’s respiratory group. He said HomeFill increases patient mobility because patients with chronic obstructive pulmonary disease, for example, where continuous oxygen is the accepted treatment, no longer have to worry about running out of oxygen if they use up more oxygen by being more mobile. With the HomeFill system, the patient usually has two cylinders that he or she can refill. Invacare said the cylinders contain enough oxygen to provide oxygen therapy for up to five hours each.
• The Kodak Molecular Imaging Systems (New Haven, Connecticut) unit of Eastman Kodak (Roch-ester, New York) has introduced two new digital imaging systems for in vivo molecular imaging research in fields such as cancer, heart disease or drug discovery. The Kodak Image Station In-Vivo F and FX systems feature Kodak’s digital image capture technology for highly sensitive optical imaging of biological processes at a molecular level. The In-Vivo FX system includes a digital X-ray imaging module in addition to its optical imaging capability. Molecular imaging identifies molecular abnormalities that are the origin of disease at a very early stage, which can expedite the development of therapeutic pathways that could help cure that disease.
• Medtronic (Minneapolis) reported the U.S. introduction of the SelectSecure Lead System, which received approval by the FDA in early August. The company said the Model 3830 lead is the world’s thinnest bipolar lead, adding, “Its lumenless design allows for flexibility and a smaller body size (4.1 Fr) without sacrificing insulation thickness.” Medtronic said the SelectSecure system is the industry’s first lead designed to enable physicians to reach selective sites of the right heart, using a deflectable catheter to allow positioning of the lead in select locations in either the right atrium or ventricle. The SelectSecure pacing lead and SelectSite catheter can be used with pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy (CRT) devices, including CRT-pacemakers and CRT-defibrillators. Medtronic said leads typically have been designed to be placed in the apex of the right ventricle (RV) or right atrial appendage, but recent studies have shown that right ventricle apical pacing may cause mechanical and electrical dyssynchrony, which in turn may increase the patient’s risk of atrial fibrillation and heart failure hospitalizations.
• Mentor (Santa Barbara, California) reported that it has launched in the U.S. its new Self-Cath Hydrogel intermittent urinary catheter for the management of bladder control and urinary retention. Launches in international markets are planned soon. The Self-Cath Hydrogel features micro-bead lubricant coating that reduces urethral friction, while the introducer tip is designed to reduce the risk of urinary tract infections. The hybrid design of the catheter, combined with contact-free catheter usage and a telescoping extension sleeve, are intended to provide additional protection against cross contamination of the catheter, which can lead to infection. The compact, pocket-sized packaging presents a significant improvement over conventional catheters in maintaining privacy and ease of use, Mentor said.
• Olympus (Melville, New York) said it received FDA clearance for its C-reactive protein (CRP) latex assay as an independent cardiac risk marker. It said that measurement of CRP “can have a role in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.” The company said that “high sensitive application measurements, when used in conjunction with traditional clinical laboratory evaluations, may be useful as an independent marker of prognosis for recurrent events in patients with either stable coronary disease or acute coronary syndromes.” The Olympus CRP Latex assay offers three applications covering a variety of measuring ranges to quantify C-reactive protein in human serum, including normal (5 mg/L to 170 mg/L), sensitive (cardiac) (0.5 mg/L to 20 mg/L) and highly sensitive (neonatal) (0.05 mg/L to 2.00 mg/L). The assay is designed for use on Olympus’ full line of chemistry-immuno analyzers, including the AU400/400e, AU600, AU640/640e, AU2700 and AU5400.
• Osteotech (Eatontown, New Jersey), a provider of human bone and bone connective tissue for transplantation and a manufacturer of biomaterial and implant products for musculoskeletal surgery, reported the release of the Graftech Lordotic Cervical Spacer, the newest addition to the company’s Graftech Bio-Implant product line. The Graftech Lordotic Cervical Spacer features 7 degrees of lordosis, and, along with the Graftech Cervical Spacer, is engineered from dense cancellous tissue. Osteotech said its two cervical spacer alternatives would provide surgeons with a number of choices to conform to a patient’s spinal anatomy. The Graftech Lordotic Cervical Spacer is available in a range of heights and sizes and uses existing instrumentation already available to surgeons.
• Power3 Medical Products (The Woodlands, Texas), a proteomics company engaged in the discovery of protein footprints, pathways and mechanisms of diseases, said it has filed a provisional patent application with the U.S. Patent and Trademark Office for the company’s blood-based Alzheimer’s disease (AD)-specific diagnostic test. The patent application is being filed in conjunction with research institutions in the Houston area, with Power3 having an exclusive license to commercialize the technology involved. The application is in support of the company’s planned third pre-IDE application to be filed with the FDA to seek their guidance on aspects of the approval process for the diagnostic tests being commercialized by the company. The test separates the proteins present in a patient’s blood sample, analyzes a panel of protein biomarkers using proteomic techniques, and determines whether or not the patient has AD based on the quantity of the biomarkers in the patient’s sample combined with biostatistical analysis. The company said it also intends to extend the technology to high-throughput immunodiagnostics suitable for clinical laboratories and physicians’ offices. Power3 also said it has discovered a group of breast cancer protein biomarkers in preliminary studies of blood serum, and the company’s hope is that it will lead to an early screening test for breast cancer could be developed based on the discovery as a replacement for mammography. The company said that by monitoring the blood serum concentrations of those proteins and then subjecting the results to biostatistical analysis, Power3 scientists believe they will be able to use the biomarkers to discriminate among women with breast cancer, those with benign breast disease, and those with no detectable breast cancer.
• Respirics (Raleigh, North Carolina) has rece-ived FDA 510(k) clearance to market MD Turbo, an accessory device for use with pressurized meter dose inhalers (MDIs). The device is scheduled for commercial release later this year. The company said MD Turbo addresses two of the biggest problems associated with the use of MDIs – coordination of inhalation and actuation of the drug canister, and accounting for the amount of medication remaining in the canister. When used in conjunction with a number of commercialized MDIs, the device enables patients to actuate their inhalers by simply breathing in. The company said this breath-actuation feature can reduce the timing errors many patients experience when they attempt to use their inhalers manually. MD Turbo also includes an electronic dose counter that shows patients how many doses remain in their inhalers. MD Turbo will be available by prescription by year-end.
• Roche Diagnostics (Pleasanton, California) said the results of the ALTS (ASCUS/LSIL Triage Study for Cervical Cancer) clinical trial, which were published in the July 20 issue of the Journal of the National Cancer Institute, support the use of genotyping certain human papillomavirus (HPV) high-risk types, particularly HPV16. The company said HPV genotyping may be important to assessing the risk of developing pre-cancerous conditions or cervical cancer in women with either ASCUS (an ambiguous type of cellular abnormality formally called “atypical squamous cells of undetermined significance”) or LSIL (mildly abnormal cells formally called “low-grade squamous intra-epithelial lesions”) results of Pap testing. Roche provided research reagents that led to providing geno- typing information for the study. Its Linear Array HPV Genotyping Test, which has received CE-mark certification for in vitro diagnostic use in the European Union, includes both the low- and high-risk genotypes.
• Siemens Medical Solutions (Malvern, Pennsylvania) has received FDA 510(k) clearance for the Arcadis Avantic, a new mobile C-arm system. The new mobile surgery C-arm is best suited for advanced imaging requirements in trauma and spine surgery, general surgery and urology, orthopedic surgery and pain management, gastroenterology and vascular surgery. The Avantic has 20 kW of power – the strongest in the industry, according to the company – up to 250 mA output and a 13-inch image intensifier. The new design also features reduced weight and smaller footprint requirements, Siemens said. A compact, swiveling operating panel and color-coded brake and control elements enable easy system movement and operation, according to the company. The product is based on syngo, Siemens’ intuitively operated software platform for different modalities.
• Smith & Nephew Orthopaedics (Memphis, Tennessee) reported the launch of AchieveCAS for computer-assisted knee implant surgery. AchieveCAS is a computer system with custom-designed software, infrared camera and surgical instruments. The system is designed to allow the surgeon to navigate a total knee during surgery, allowing surgeons to more precisely place implants, particularly within smaller incisions, through enhanced guidance and visualization. The system allows for the more accurate alignment and placement of a Smith & Nephew implant and may extend the implant’s lifespan by reducing uneven wear, the company said. AchieveCAS already is available for hip implants. The launch is part of a five-year exclusive business relationship between Smith & Nephew and Orthosoft (Montreal), a company specializing in software development for computer-assisted surgery.
• St. Jude Medical (St. Paul, Minnesota) reported the first implant of the SJM Biocor stented tissue valve in the U.S. The company received FDA approval of the heart valve, its first stented tissue valve in the U.S. market, in early August. The first U.S. implant of the device was performed on Aug. 12 by James Taylor, MD, a cardiothoracic surgeon at St. Francis Hospital (Roslyn, New York). “I was very pleased with Biocor’s ease of implantability,” said Taylor. “The FlexFit stent combined with the low post height to greatly ease placement of the valve.” In addition to the SJM Biocor aortic and mitral models, the company has received FDA approval for the SJM Biocor Supra stented tissue aortic valve, a supra-annular valve im-planted above the annulus, the supporting structure at the base of each aortic valve leaflet.
• Third Wave Technologies (TWT; Madison, Wisconsin) reported FDA clearance of its Invader UGT1A1 molecular assay for in vitro diagnostic use, making it the first pharmacogenetic test to be approved by the agency for use as a companion diagnostic to a specific drug therapy. The drug is Camptosar, a chemotherapy product used to treat colorectal cancer. The FDA, which one analyst said was the motivator behind the test, said the test “will help doctors make personalized drug treatment decisions for some patients,” joining what the agency called “a growing list of genetic tests used by physicians to personalize treatment decisions.” The Invader UGT1A1 test is cleared for use to identify patients who may be at increased risk of adverse reaction to the chemotherapy drug Camptosar (irinotecan) by detecting and identifying specific mutations in the UGT1A1 gene that have been associated with that risk, the company said.
• Toshiba America Medical Systems (TAMS; Tustin, California) has introduced the Famio ultrasound system, a high-end, gray-scale 2-D system. TAMS said, “superior image quality is achieved through Famio’s smart technologies, including the Digital Continuous Beam Former and Tissue Harmonic Imaging.” The company said the compact and mobile design of Famio “is ideal to suit the needs of physician office settings, where space is at a premium.” The system includes ergonomically designed transducers for “optimal sensitivity and resolution from near to far field in any clinical situation,” and TAMS said its plug-and-play feature ensures the system can immediately contribute to the productivity of the practice.
• Trimedyne (Irvine, California), a manufacturer of lasers and fiber optic devices for minimally invasive surgical procedures, said it has begun marketing the new VaporMAX Side-Firing Laser Device for use with its high-power, 80-watt Holmium laser for the treatment of benign prostatic hyperplasia, or enlarged prostate. Trimedyne said its VaporMAX device vaporizes tissue faster than other currently marketed side-firing laser devices, based on animal tissue laboratory testing and published data, minimizing procedure and operating room time. It said testing has shown the VaporMAX device to be more durable than other side-firing devices, enabling even large prostates to be treated with just one VaporMAX device, further reducing the cost of the procedure. The company also said that the VaporMAX device qualifies for the new, higher Medicare reimbursement rate under Ambulatory Payment Classification Code 2525.
• TriPath Imaging (Burlington, North Carolina) and Ventana Medical Systems (Tucson, Arizona) said that TriPath has received 510(k) clearance from the FDA for the Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu. HER-2/neu protein analysis aids in the management of breast cancer patients and is used by physicians to aid in prognosis and prediction of therapy outcomes for breast cancer. In May, the companies reported 510(k) clearance for VIAS when used with the Ventana Estrogen Receptor and Progesterone Receptor assays.
• Vascular Solutions (Minneapolis) reported 510(k) clearance from the FDA for the Pronto-Short extraction catheter and the subsequent immediate launch of the product through its direct U.S. sales force. The Pronto-Short is a product line extension of the Pronto extraction catheter designed to remove inter-arterial thrombus through a proprietary catheter using syringe aspiration. It is designed for use in de-clotting arterial-venous grafts and fistulas that are used in hemodialysis procedures. CEO Howard Root said, “Due to their frequent use, dialysis grafts and fistulas are prone to clotting, with each patient requiring on average one de-clot procedure each year. Since these grafts and fistulas are relatively large and since direct percutaneous access is used to perform the de-clot procedure, a larger and shorter version of the original Pronto catheter is required for this procedure.” He said the Pronto-Short combines these features with the company’s Silva tip to offer “a very simple, unique and low-cost approach to removing thrombus in A-V grafts and fistulas.” The company estimates the U.S. market opportunity addressed by the Pronto-Short to be about $100 million annually.
• ViaCell (Cambridge, Massachusetts), a clinical-stage biotechnology company, reported the publication of results of a preclinical study demonstrating that administration of stem cells sourced from umbilical cord blood and using ViaCell’s process significantly improved heart function in an in vivo model of myocardial infarction. The results of the preclinical study, sponsored by ViaCell and conducted in association with the Toronto General Research Institute at Toronto General Hospital, have been published in the Aug. 30 Cardiovascular Surgery Supplement of Circulation, the journal of the American Heart Association. As described in the publication, four weeks after cell transplantation, engrafted human unrestricted somatic stem cells were detected in the infarct region of the heart, and the implanted cells were shown to improve regional perfusion and wall motion of the infarct regi-on compared to controls. In addition, ejection fraction increased in the transplant group compared to a decrease in controls.
• VivoMetrics’ (Ventura, California) LifeShirt is being used in a study to help determine the effects of post-traumatic stress disorder (PTSD) on cardiologic response in young children and parents who were affected by the 9/11 terrorist attacks. The LifeShirt will be used by the Mount Sinai School of Medicine‘s Child and Family Resilience Program and the Jewish Board of Family and Children’s Services’ Center for Trauma Program Innovation (both New York). “The interesting thing about it is as far as we know this is the first study that’s going to be objectively gathering physiologic data during the mother-child interaction,” said Elizabeth Gravatte, vice president of sales and marketing for VivoMetrics. The Center for Trauma Program Innovation is a specialized program designed to develop and implement programs for the treatment of traumatized children and youth served by New York City’s mental health and social service providers. The LifeShirt is non-invasive and continuously collects, records and analyzes a range of cardiopulmonary parameters, the company said. It is lightweight and has embedded sensors that collect pulmonary, cardiac, posture and activity signals. Data collected by integrated peripheral devices measure blood pressure, blood oxygen saturation, EEG/EOG, periodic leg movement, temperature, end tidal CO2 and cough.
• Xenogen (Alameda, California) launched its IVIS 3D Imaging System, which it said is the first 3-D biophotonic imaging system, at the 4th annual Society for Molecular Imaging (SMI; Kerrville, Texas) meeting in Cologne, Germany. The IVIS 3D Imaging System is “a camera that’s capable of taking multiple view images” of what is taking place inside a live mouse for drug development and gene expression studies, the company said. The device allows researchers to use “real-time imaging to monitor and record cellular and genetic activity within a living organism,” according to Xenogen.