Tensys Medical (San Diego, California) has moved beyond product introduction and into the first sale of its Tensys T-Line product, a non-invasive blood pressure monitoring device for use by anesthesiologists during surgery that its developers say gives information as good or better than the gold standard of a A-Line transducer, which involves the insertion of an arterial catheter.
The product was approved last November following the company's strategy of first getting 510(k) approval to get the technology approved and then refining it before moving to get the second 510(k) for the final product that it took to the marketplace in March, said CEO Michael Martin, who joined the company in November after holding senior management positions with companies including GE Medical Systems (Waukesha, Wisconsin).
Martin told The BBI Newsletter that "never" in his career had he seen a product being so widely adopted. "It happened so swiftly that the pipeline is 100-plus accounts and growing every day, and we've only been at this since March 21," he said last month.
St. Luke's Episcopal Hospital (Houston, Texas), home of the Texas Heart Institute, was the first hospital to purchase the T-Line product, which includes a transcutaneous sensor device placed over the radial artery. Each sensor is single-use. The device "locates and tracks the radial artery while continuously displaying a self-calibrated, arterial pressure waveform" using its patented Tensymetry technology. Before the product launch, the company said it was tested in about 500 surgical cases nationwide.
Elsewhere in the product pipeline:
Abbott Laboratories (Abbott Park, Illinois) introduced the LifeCare PCA3 Infusion System, a patient-controlled analgesia (PCA) device. PCA devices are designed to allow hospital patients to control the flow of their pain medication, within specified limits. A built-in bar code reader that works in concert with bar code-labeled Abbott prefilled vials that snap into the pump makes PCA3 the first PCA pump to incorporate this integrated safety feature.
Abiomed (Danvers, Massachusetts) has received FDA approval for commercial distribution of the company's new AB5000 Circulatory Support System drive and control console. The AB5000 console will drive one or two BVS 5000 blood pumps, either in the hospital or for transport of patients between hospitals. Incorporating an electronic interface, the AB5000 is designed to improve the convenience and ease of use of the current BVS blood pump. The first of Abiomed's planned new single-use blood pumps is intended to provide improved quality of life and mobility for post-cardiotomy and other short-term bridge-to-recovery patients, and is currently under review by the FDA.
American Medical Systems (AMS; Minnetonka, Minnesota) said its Monarc subfascial hammock has received FDA approval and will be available for commercial release in the U.S. by mid-year. Monarc is the fourth in a series of products AMS has developed to treat urinary incontinence in women, joining SPARC, In-Fast Ultra and the Artificial Urinary Sphincter to offer a broad set of minimally invasive surgical options. With Monarc, physicians introduce a supportive mesh subfascially during an outpatient procedure that takes just minutes to complete. This approach may eliminate the need for cystoscopy, the company said.
Andromed (Montreal, Quebec) received CE mark approval for its Androscope electronic stethoscopes and accessories, along with its Androsonix biological sound sensor. All products are also FDA- and Health Canada-cleared for sale for diagnosis of cardiac and pulmonary pathologies. The electronic stethoscope's advanced filtering provides clarity of sound and enhances physicians' ability to diagnose heart and lung pathologies, Andromed said. It enables users to remotely auscultate cardiac and pulmonary sounds. The electronic stethoscope also is equipped with a link port to capture sounds and transfer signals to a PC or a PDA for archiving and analysis. The Androscope i-stethos is designed to link up with the Androsonix, a non-invasive and single-use biological sound sensor that is the company's core technology.
BioLucent (Aliso Viejo, California) reported the launch of the Spot Compression MammoPad. The product comes in four different sizes and shapes and is designed to make spot compression views in diagnostic mammography more comfortable for women who undergo the procedure. Spot Compression MammoPad is most effective when it is applied to the spot compression paddle and is used in combination with the company's standard MammoPad, which is applied to the magnification tower or image receptor.
CardioTech International (Woburn, Massachusetts) has completed preparations for initiation of a human clinical trial for its CardioPass coronary artery bypass graft. The trial is scheduled to be initially conducted in Brazil and will involve several institutions. CardioTech began entering the patient recruitment phase last month and expects to perform the first human implant during the current quarter. Clinical endpoints for the pilot study are major adverse clinical events, myocardial infarction, urgent/elective intervention or death. The CardioPass graft is manufactured from CardioTech's ChronoFlex biodurable polyurethane and is intended for use as a synthetic substitute for the saphenous vein that is commonly used to bypass diseased coronary arteries, eliminating the need for a second simultaneous operation, the company said.
Carl Zeiss Meditec (Dublin, California) signed an agreement with Notal Vision (Tel Aviv, Israel) for worldwide distribution rights for a new perimetry device for the detection and management of age-related macular degeneration (AMD), the most common cause of severe, irreversible vision loss. Carl Zeiss Meditec plans to introduce the product in the U.S. this fall and in Europe and Asia sometime later. The technology developed by Notal Vision employs a concept known as hyperacuity to non-invasively detect the retinal lesions from AMD that can lead to loss of central vision.
CryoCath Technologies (Montreal, Quebec) said that two presentations made at last month's annual meeting of the German Cardiac Society in Mannheim, Germany, documented the clinical experience of two European cardiovascular centers using its Arctic Circler, a minimally invasive catheter designed to treat patients with atrial fibrillation (AF). Combined, the two centers have used the Arctic Circler to treat 147 veins in 43 patients with AF, refractory to drugs, representing about half of the total European experience with the product. Acute success rates reached 98% in one study and 92% in the other. The company is in the process of expanding the number of participating centers from the current eight to 18 centers by mid-year.
EDAP TMS (Vaulx-en-Velin, France) said that its high intensity focused ultrasound (HIFU) division, EDAP SA, was issued a Medical Device License for the Ablatherm from Health Canada. Ablatherm, using HIFU technology, treats patients who have been diagnosed with localized prostate cancer and would prefer a minimally invasive treatment option.
Endocare (Irvine, California) said that two new studies demonstrating the safety and effectiveness of cryoablation for treating renal (kidney) cancer were presented at the annual meeting of the American Urological Association. A total of 99 patients took part in the two studies that were conducted at several U.S. hospitals. In a long-term follow-up study of 76 patients treated by cryoablation for small renal cancers (median tumor size was 2.5 cm), the results showed that 93% of the patients showed complete radiographic resolution of their lesion with a disease-specific survival rate of 100%. The median hospital stay was two days and none of the patients developed delayed hemorrhage, urinary leaks or renal toxicity. The other study of 23 patients with 25 renal tumors (ranging in size from 1.5 cm to 10 cm) focused on the use of cryoablation for assisting in partial nephrectomy. The investigators concluded that cryoablation is an effective alternative for assisting in partial nephrectomy and facilitating the excision of localized renal masses.
EP MedSystems (West Berlin, New Jersey) received regulatory approval from its European Notified Body for the ViewMate intracardiac imaging system, allowing for sale of the ViewMate and associated disposable ultrasound imaging catheters within the 15 countries of the European Community. The company submitted its 510(k) filing to the FDA for the system in April. The ViewMate system consists of an advanced ultrasound imaging console with an image monitor and a thin disposable catheter fitted with a transducer on its tip. The system allows cardiologists and electrophysiologists to identify, diagnose and assist in the treatment of a number of heart abnormalities and conditions.
Guidant (Indianapolis, Indiana) launched the Multi-link Penta Coronary Stent System for the treatment of coronary artery disease in Japan. The system features Access-Link NK technology, a feature developed to allow the stent to be flexible enough to be maneuvered through a patient's vessels while still retaining the strength needed to prop open a previously blocked artery. The system is mounted on a delivery system with a balloon that is designed to allow the system to be more easily delivered to the site of the coronary blockage.
Gynecare (Somerville, New Jersey), the women's health division of Ethicon, a Johnson & Johnson company, introduced Gynecare Gynemesh PS, the first polypropylene mesh support material for female pelvic floor repair. The lightweight material offers permanent, yet soft and supple support in a variety of applications, including cystocele, rectocele and vaginal vault suspension. Gynemesh PS is 70% more flexible than standard mesh and the knitted construction allows the surgeon to easily cut the mesh into different sizes and shapes.
HealthTronics Surgical Services (Marietta, Georgia) said the FDA approved its high-energy OssaTron orthopedic shock wave device for the treatment of chronic lateral epicondylitis (also known as tennis elbow). It said the OssaTron is the only high-energy orthopedic shock wave device approved for one-time treatment of epicondylitis. The OssaTron already is approved for treatment of plantar fasciitis (heel pain) and now becomes the only such device approved for multiple indications, the company said. The FDA approved the device based on the results of a 225-patient, multi-center study in which 90% of treated patients received a benefit from the treatment and 64% had an "excellent" or "good" outcome.
HemoSense's (Milpitas, California) INRatio Prothrombin Time (PT) Monitoring System has been released for sale in the U.S. for patient self-testing at home and for use by medical professionals. INRatio tests and records the clotting time of blood via PT testing, which is the key blood test used for monitoring patients taking oral anticoagulants such as Coumadin. The Centers for Medicare & Medicaid Services (CMS) recently approved reimbursement for patients with mechanical heart valves, enabling greater access to PT self-testing at home. HemoSense said private insurance companies are expected to reimburse as well.
Imaging Diagnostic Systems (Fort Lauderdale, Florida) reported the submission of its premarket approval application to the FDA for its Computed Tomography Laser Mammography system. The system visualizes the blood supply of tumors without the use of X-rays and without breast compression. It is intended to be used as an adjunct to mammography, for women who have dense breasts and equivocal mammograms, where the system can provide the radiologist with additional information to guide biopsy recommendations. The company said the system is the first breast-imaging system that uses laser technology and patented algorithms to create 3-D cross-sectional images of the breast.
Inamed (Santa Barbara, California) said that Humana (Louisville, Kentucky) has expanded its coverage guidelines to include the Lap-Band System as a covered benefit for the treatment of morbid obesity. The company said that the system has been shown to significantly reduce the risk of co-morbidities associated with obesity such as diabetes, cardiovascular disease and hypertension, and may lower overall healthcare costs.
Karl Storz Endoscopy-America (Culver City, California) reported the release of the Digital Imaging Platform, featuring full serial digital interface video compatibility throughout for high-resolution, high-fidelity images. The Digital Imaging Platform includes the first all-digital camera system, the first image capture device with a large format touch panel interface, and the first medical-grade LCD flat-panel display to feature integrated digital imaging.
LuMend (Redwood City, California) launched its fifth-generation catheter platform, the Frontrunner X39 CTO Catheter. The X39 is about 50% smaller compared to previous generations. The company also reported safety data for blunt micro-dissection, the technology behind the Frontrunner family of catheters. The Frontrunner X39 Catheter is used to treat CTOs (complete blockages in the coronary arteries). It has a distal tip size of .039", with a 30% increase in distal tip opening power compared to previous generations. The company said that because of the catheter's small size, it handles like a guide wire. It uses controlled, blunt micro-dissection to gently separate atherosclerotic plaque, creating a passage through the CTO. That enables guide wire access and provides physicians with the opportunity to treat patients using less-invasive coronary procedures such as balloon angioplasty or stenting.
MacroPore Biosurgery (San Diego, California) said U.S. patent No. 6,531,146 has been issued for its SurgiWrap bioresorbable thin film. SurgiWrap has received CE mark approval to prevent postsurgical adhesions in cardiovascular, general, spinal and obstetric surgeries. In the U.S., it is approved for soft tissue support and reinforcement, and for adhesion prevention in specific ear, nose and throat procedures.
Mallinckrodt (St. Louis, Missouri), a Tyco Healthcare (Exeter, New Hampshire) business, said its Optimark contrast media is now the first magnetic resonance imaging agent that is FDA-approved for administration by power injection. Optimark contrast media is packaged in plastic Ultraject prefilled syringes compatible with Mallinckrodt's Optistar LE injector and glass vials in a range of sizes.
The FDA approved the Activa Dystonia Therapy System, or "brain pacemaker," made by Medtronic (Minneapolis, Minnesota) via a humanitarian device exemption. The brain implant is intended to help control some symptoms of dystonia, a rare, debilitating movement disorder. The deep brain stimulator already was approved for treating Parkinson's disease and essential tremor and now is approved for treating primary dystonia, which has no known cause. The approval broadens the system's use to people who get little or no relief with medication. The system consists of electrodes and a neurostimulator, with the electrodes implanted into the brain and connected by leads under the skin to the neurostimulator implanted in the chest. The neurostimulator sends a stream of tiny electrical pulses to the brain, suppressing symptoms. When the device is implanted in both sides of the brain, two separate systems are used. To turn the stimulator on and off, the patient touches a hand-held magnet over the neurostimulator. The FDA said it based approval of the system on a review of 34 scientific case studies in which 201 people with primary or secondary dystonia had the device implanted and received deep brain stimulation. Unlike primary dystonia, which has no known cause, secondary dystonia is caused by an underlying disease such as Parkinson's, a brain tumor or a stroke. The patients in the studies were followed for about one year. Around 2,000 people a year in the U.S. are expected to be candidates for the device.
Medtronic Sofamor Danek (Memphis, Tennessee) reported the first U.S. implant of the Maverick Artificial Disc, which kicks off the clinical trial of the device. The procedure was performed by Hallett Mathews, MD, of MidAtlantic Spine Specialists (Richmond, Virginia). The clinical trial is designed to evaluate the safety and effectiveness of the artificial disc and potentially support an application to the FDA. The device is designed to replace damaged discs in the lumbar, or low back region. The purpose of the clinical trial is to compare the outcomes of patients who receive an artificial disc with those of patients who undergo a traditional lumbar fusion.
NeoRx (Seattle, Washington) said the FDA has lifted the clinical hold on the company's Skeletal Targeted Radiotherapy (STR) product candidate for multiple myeloma, a cancer of the bone marrow. The decision followed NeoRx's submission of data from a dosimetry study of STR in which multiple myeloma patients were treated and detailed radiation dosimetry data were collected, as previously requested by the FDA. NeoRx continues to follow these patients for safety and efficacy results. Three-year survival data on the STR Phase I/II patients will be available by the end of 2003. NeoRx said it expects to submit a full Phase III study protocol before the end of the second quarter for the FDA's review.
Orthovita (Malvern, Pennsylvania) received investigational device exemption approval from the FDA allowing the company to begin a second pilot human clinical study to evaluate the use of Cortoss Synthetic Cortical Bone Void Filler in the treatment of vertebral compression fractures (VCF) using the kyphoplasty treatment technique, in which an inflatable bone tamp is used to attempt to reduce the fracture and create a void into which the biomaterial can be injected. Cortoss will be injected percutaneously through the skin into the fractured vertebra to stabilize and restore load-bearing capacity. The new U.S. study will assess the ability of Cortoss to provide both pain relief and improvement in function to the patient by providing stability to the fractured vertebra. The pilot study will be conducted at four sites and will enroll a total of 20 patients.
PerkinElmer (Boston, Massachusetts) reported the launch of the Delfia Celiac Disease Hybridization assay for ascertaining an individual's susceptibility to celiac disease, an autoimmune disorder that results in sensitivity to gluten, found in wheat, rye and barley. The test is suitable for use not only with liquid blood samples but also for blood samples on filter paper, which do not require prior extraction of DNA.
Roche Diagnostics (Pleasanton, California) said it has begun installation of its West Nile virus blood screening systems at leading North American blood centers, in preparation for clinical trials scheduled to begin on or before July 1. The company said the test, which uses its polymerase chain reaction technology to amplify the genetic material of West Nile virus to detectable levels, represents an important step in helping blood banks ensure the safety of blood and blood products used in transfusions and other medical procedures.
Smith & Nephew's Orthopedic Division (Memphis, Tennessee) reported the successful completion of the first minimally invasive total knee replacement surgery to be enhanced by high-precision, computer-guided navigation. Using minimally invasive surgical instruments joined with a software application developed with BrainLAB (Munich, Germany), the company said it has achieved an "unprecedented technological convergence that previews the future of joint replacement surgery." Performed by Dr. John Lange and Dr. Paul Schwartz of Shasta Orthopaedics and Sports Medicine (Redding, California), the procedure used computer-guided surgical navigation to provide highly accurate implant alignment and real-time vision of the surgical site through an incision 60% shorter than that of traditional total knee replacement. The shorter incision means less trauma to underlying muscle and soft tissues a benefit to patients that leads to a smaller scar, less post-operative pain and a faster return to physical activity.
SuturTek (North Chelmsford, Massachusetts) received FDA 510(k) clearance to market its FastClose Device for fascia closure, the first needle-protected suturing product. The device is the first wound closure technology product designed to protect surgeons, nurses, and operating room staff against the risk of suture needlesticks during fascia closure, the company said.
Urologix (Minneapolis, Minnesota) reported FDA approval of the new Cooled ThermoCath treatment catheter, used in conjunction with the Targis microwave generator. The company said the Cooled ThermoCath incorporates design features to enhance the treatment of benign prostatic hyperplasia (BPH) and will strengthen Cooled ThermoTherapy/TUMT as a leading minimally invasive treatment for BPH. Early results from clinical studies indicate rapid necrosis formation and outcomes achieved in 28.5 minutes.
VivoMetrics (Ventura, California) has introduced a pediatric version of its LifeShirt System for children ages 5 to 17. The first monitoring device for children of its kind, the pediatric LifeShirt System allows researchers and clinicians to view real-world physiologic data on young patients in a variety of settings. The company said it designed the pediatric LifeShirt System to meet an increased demand for effective monitoring of young patients, particularly in screening for obstructive sleep apnea. With the pediatric LifeShirt System, children can be screened for that condition and other sleep-related disorders at home.
W.L. Gore & Associates (Flagstaff, Arizona) said the Gore-Tex Intering Vascular Graft is now available in 4 mm to 6 mm, 4 mm to 7 mm and 6 mm sizes specifically configured for vascular access. The Gore-Tex Intering Vascular Graft provides easier handling and placement during vascular surgery and is the lowest profile, radially supported graft available today, the company said. The graft resists kinking and compression, due to an all-ePTFE, no-profile radial support concealed within its smooth wall. The grafts' radial support structure also allows them to conform exceptionally well to the native vessel.