Pall (East Hills, New Jersey) has won FDA approval for its Donor Blood Reinfusion System, which allows surgeons to withdraw, filtrate and reinfuse a patient's own blood with one device during surgeries. Not only does it reduce the number of devices needed for those procedures to one, but it also has the advantage of alleviating the need for donor blood, thereby avoiding the risk of infection associated with that procedure. "We're creating a new niche in the marketplace," Sam Wortham, president of the medical group at Pall, told The BBI Newsletter, adding that "the drive for this is to avoid having to use random donor blood."
The Donor system already is approved in the UK, Canada and throughout the Middle East. "Our biggest success so far has been in the UK," Wortham said, noting that it is due to concerns over risking contracting infections like "mad cow" disease through transfusions with donor blood. "Wherever we've seen the greatest sensitivity [to randomly donated blood], we've seen the greatest demand," he said.
Pall said the Donor Blood Reinfusion System mitigates transfusion risk with the incorporation of the Pall LipiGuard VS filter media technology into the system. The company said it is the "only reinfusion system where the filtration step is an integral part of the complete package."
Jerry Ortolano, vice president of scientific and laboratory services at Pall, said the medical community has long considered two alternatives for reinfusion to be adequate, i.e., either direct reinfusion of a patient's blood or washing the blood outside the body and reinfusing it. However, today it is known that the blood can undergo changes outside the body, such as red blood cells breaking up, or the blood could undergo activation, he said. "It turns out that in both conditions, both products are problematic," he said, citing indications that reinfusing such materials as fat globule can cause fat embolism syndrome during surgeries.
Ortolano said the other thing Pall has seen in its research is that blood reinfused during cardiac surgery can put a patient at risk for pulmonary dysfunction. The Donor system, in effect, is designed to lower the stressors on blood outside the body and therefore lower the risk for the patient once it is reinfused. "Since Donor is a closed system, it also reduces the risk of airborne contamination," the company said.
Pall suggested that orthopedic surgery would be a prime situation for use of the Donor system. It said there were about 1.5 million orthopedic surgeries for joint replacement in the U.S. in 2002, with that number expected to increase by 8% annually.
Elsewhere in the product pipeline:
Abiomed (Danvers, Massachusetts) reported that St. Luke's Medical Center (Milwaukee, Wisconsin) is the first hospital to purchase its AB5000 Circulatory Support System console technology, acquiring two of the systems. Abiomed reported FDA approval to market the AB5000 console on May 1, and it was displayed for the first time at the American Association for Thoracic Surgery (AATS) meeting in Boston, Massachusetts, in May. The AB5000 will drive and control one or two BVS 5000 blood pumps, either in the hospital or for transport of patients between hospitals.
Alveolus (Charlotte, North Carolina), a developer of non-vascular interventional stent technology, received approval last month via a 510(k) from the FDA on a new implantable device to be used specifically in interventional pulmonary stenting. This device, called the Stent Technology System (STS), is now commercially available in the U.S. Eric Mangiardi, president and CEO, told BBI that the company submitted its 510(k) on March 24, and that the approval came rapidly. Alveolus said the stent system is uniquely designed for the characteristics and challenges of specific body lumens. It developed the STS to open passageways blocked due to tumor growth and benign obstructive lumen conditions, such as strictures, stenoses or malacia (morbid softening of tissue). With the help of this new stent system, the company hopes that patients with these conditions or diseases will be able to breathe more freely.
Beckman Coulter (Fullerton, California) introduced Total IgE, a new diagnostic laboratory test to help physicians determine general allergic reactions. Available on the company's Immage immunochemistry system, the fully automated Total IgE assay is designed for the quantitative determination of Immunoglobulin E (IgE) in human serum and plasma. The Total IgE assay features a measuring range from 5 to 30,000 IU/mL, 24-month reagent stability and calibration stability of 30 days. The new assay expands the menu of the Immage system, which the company said helps labs consolidate instrument systems, reduce their number of send-out tests and lower costs. The Immage system is a fully automated, random-access immunochemistry system for the analysis of proteins. It features two on-board measurement methodologies: rate nephelometry and rate near-infrared particle immunoassay (NIPIA). Rate nephelometry is used for accurate analysis of proteins and drug analytes. Rate NIPIA increases the analytical sensitivity of the instrument to detect analytes at lower concentration levels, including digoxin, ferritin and C-reactive protein.The methodology also reduces interferences from biological substances, such as bilirubin and hemoglobin.
Biosite (San Diego, California) has begun full-scale market introduction of the Triage Cardio ProfilER, a new rapid diagnostic intended to aid in the evaluation of chest pain patients. By combining four markers of cardiovascular disease in one test panel, the 15-minute diagnostic is intended to provide physicians with a fast and convenient means of assessing chest pain patients for a variety of conditions in order to potentially enable earlier therapeutic intervention or disease rule-out. The ProfilER provides rapid, simultaneous, quantitative measurement of four disease markers creatinine kinase (CK-MB), myoglobin, all forms of troponin I and b-type natriuretic peptide (BNP) within 15 minutes. Based on the portable Triage MeterPlus testing platform, the Triage Cardio ProfilER can be performed at the point of care or in a laboratory. Once an initial test is performed, physicians can perform follow-up analyses with either Biosite's Triage Cardiac Panel or Triage BNP Test, which are more disease-specific and operate on the same platform as the Triage Cardio ProfilER.
Boston Scientific (Natick, Massachusetts) received 510(k) clearance from the FDA last month to market the FilterWire EX Embolic Protection System to treat saphenous vein graft (SVG) disease. The FilterWire EX system is the first filter-based system approved for SVG treatment in the U.S., in contrast to a competing device from Medtronic (Minneapolis, Minnesota), which temporarily occludes the vessel and uses vacuum pressure to retrieve the particles. SVG disease occurs when saphenous veins harvested from the leg for use in coronary artery bypass graft surgery develop atherosclerosis. The FilterWire EX system is a low-profile embolic filter mounted on a guidewire that is designed to reduce complications during balloon angioplasty and stenting procedures in SVGs. It captures embolic material that becomes dislodged during cardiovascular interventions.
CardioDynamics (San Diego, California) reported the publication of an international clinical study demonstrating the significance of the company's ICG technology for pacemaker optimization in Pace, a peer-reviewed publication in the field of electrophysiology. The independent study, conducted by researchers at the Queen Mary Hospital (Hong Kong), University of Hong Kong and St. Jude Medical (Sylmar, California), demonstrated the utility of the company's ICG technology to determine cardiac output (amount of blood the heart pumps each minute) during pacemaker optimization compared to the echocardiography/Doppler (echo) method. Although pacemaker optimization can significantly improve a patient's cardiac output, the vast majority of patients with dual-chamber pacemakers are not optimized with echo because it is a time-consuming, expensive and operator-dependent method. The study's investigators concluded, "Previous studies have shown that optimization of the AV (atrioventricular) interval can contribute up to 40% of the cardiac output. Therefore, it is an important step to maximize the hemodynamic benefits of cardiac pacing, especially during cardiac resynchronization therapy for congestive heart failure. This study demonstrates the feasibility and ease of use of the impedance technique to determine cardiac output during left ventricular pacing with close correlation with Doppler echo."
Carl Zeiss Meditec (Dublin, California), a subsidiary of Carl Zeiss Meditec AG, reported FDA clearance of the retinal nerve fiber layer (RNFL) normative database for its Stratus OCT (optical coherence tomographer) diagnostic device. The FDA notice was received just before last month's annual meeting of the Association for Research in Vision and Ophthalmology in Fort Lauderdale, Florida, where more than 120 presentations and posters discussed this emerging technology. The company said its RNFL normative database is the only device in its category to follow this review process, therefore providing clinicians with a higher level of confidence in judging a patient's condition. The Stratus OCT is the first instrument that permits doctors to see direct cross-sectional images of the retina, similar to CT scans of internal organs using a beam of light to rapidly scan the eye and generate an image without ever touching the patient. The technology behind the Stratus OCT eliminates the need to contact the eye, which improves patient comfort and allows the test to be performed in less time. For certain conditions such as age-related macular degeneration, the Stratus OCT is able to reduce or eliminate the need for fluorescein angiography for some patients. The Stratus OCT compares test results to its database of healthy subjects to determine whether the patient falls within normal ranges.
Cook Surgical (Bloomington, Indiana), a division of Cook, said its new Fanelli Laparoscopic Endobiliary Stent Set provides fast, cost-efficient laparoscopic endobiliary stent placement that eliminates the need for external tubes and drains following endoscopic retrograde cholangiopancreatography. The Fanelli Stent Set protects ductal closures and limits the risk of bile leakage. Contrast media can be injected throughout the stent placement procedure, even while the wire guide remains in place, using the sideport. Stent placement does not require choledochotomy. Under fluoroscopy, four integrated radiopaque markers ensure visual confirmation of stent positioning. The markers also confirm proper stent deployment by indicating when the delivery system has cleared the stent and can be withdrawn. To document stent placement, the Fanelli design also allows the user to perform a completion cholangiogram. The new stent set is intended for internal biliary drainage. Separately, Cook said it has been granted FDA clearance to sell its Zenith AAA Endovascular Graft System to physicians. U.S. sales of the third-generation stent-graft system for the endovascular treatment of abdominal aortic aneurysm (AAA) began immediately, the company said. Features of the Zenith AAA system include suprarenal fixation and a graft design that allows treatment of a wide variety of patient anatomies. The system treats AAA without the need for major surgery. Patients treated with the system require just two incisions to allow the insertion of two catheters into the femoral arteries in the groin. Once the catheters are guided into position through the patient's arteries, a fabric-covered, self-expanding metal stent-graft is deployed inside the weakened section of the aorta and the surrounding vessels to relieve pressure on the aneurysm.
CryoCath Technologies (Montreal, Quebec) said it has received the CE mark for Freezor MAX for the treatment of cardiac arrhythmias such as atrial flutter. Freezor MAX is the fifth cardiac ablation product CryoCath has commercialized in Europe. The company said Freezor MAX is a catheter that delivers more cooling power than Freezor and Freezor Xtra. It has a 30% larger lumen (9 Fr vs. 7 Fr), allowing for more refrigerant to be delivered to the catheter tip and the tip itself is 33% larger (8 mm vs. 4 mm and 6 mm). By providing the maximum amount of refrigerant over a larger tip, Freezor MAX allows physicians to make larger, deeper lesions, the company said. CryoCath said it expects to broadly launch the product across Europe, leveraging the 50-plus base of centers that already have a CryoConsole installed.
Cytyc (Boxborough, Massachusetts) said that the American Society of Breast Surgeons (ASBS) supports the use of ductal lavage as a cell-based risk assessment tool in high-risk and borderline risk women to assist them in making more informed decisions regarding risk reduction and management options. The ASBS reviewed its recently adopted official position statement on ductal lavage at its recent annual meeting in Atlanta, Georgia. Cytyc's FirstCyte Breast Test is a ductal lavage procedure that can be performed in an office setting in less than an hour. The cells collected with ductal lavage are analyzed in a laboratory to determine whether they are normal, premalignant or malignant.
Endologix (Irvine, California) has submitted the first two modules of its premarket approval (PMA) application for the PowerLink System for the less-invasive treatment of abdominal aortic aneurysms (AAA) to the FDA. The company recently completed enrollment in its pivotal clinical trial that supports the safety and effectiveness of the PowerLink System. The PowerLink System PMA application is comprised of four modules. The company expects to submit all modules and its final PMA application to the FDA in 3Q03.
Gen-Probe (San Diego, California) has initiated a clinical trial to evaluate the performance of the Tigris System, its fully automated, high-throughput instrument, in clinical laboratories. Results from the trial will be used to apply to the FDA for 510(k) clearance of the Tigris System for clinical diagnostics using the company's currently marketed Aptima Combo 2 Assay, an amplified nucleic acid test for the simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae, two leading causes of sexually transmitted diseases. This multi-center study will evaluate the performance of the Tigris System using clinical specimens. The trial is designed to evaluate equivalence of Aptima Combo 2 Assay results generated on the Tigris System, with results coming from the company's currently approved manual or semi-automated Direct Tube Sampling test systems.
Guidant (Indianapolis, Indiana) last month reported the first implant in its latest heart failure clinical trial. The newest U.S. trial is designed to determine the safety and efficacy of the EasyTrak 3 lead's new features, including its unique spiral shape. During the trial, the lead will be implanted in conjunction with the Contak Renewal 3 cardiac resynchronization therapy defibrillator (CRT-D), the newest generation of the company's CRT-D systems. Guidant said the Renewal 3 CRT-D builds on the success of the Renewal family and offers a wide range of diagnostics and therapies in a new smaller physiologic shape. The first implant of the EasyTrak 3/Renewal 3 system occurred at the University of Massachusetts Medical Center (Worcester, Massachusetts). Guidant also reported the European launch of its next-generation Rx Accunet Embolic Protection System for the treatment of patients with carotid artery disease. The Rx Accunet System recently received CE mark approval. The system consists of a guide wire with a filter, developed to trap embolic material that may be generated during the carotid artery stenting procedure. The filter is designed to allow normal blood flow during the procedure, while trapping embolic particles before they can travel to the blood vessels of the brain, potentially causing a stroke. The device is designed for use with Guidant's Acculink Carotid Stent System.
Gynecare (Somerville, New Jersey), the women's health division of Ethicon, a Johnson & Johnson company, said the FDA has provided premarket approval for the Gynecare Thermachoice III Uterine Balloon Therapy System, a device indicated to treat menorrhagia due to benign causes in premenopausal women. In evaluating Thermachoice III, it was found that it allowed for more even necrosis of tissue throughout the entire endometrium. The Thermachoice system offers a less-invasive option that allows women to preserve their uterus. It is used in an outpatient procedure that can be completed in less than 30 minutes. Compared with hysteroscopic procedures, uterine balloon therapy is much simpler for a physician to perform, the company said. Women typically return to their normal activity the day after treatment.
Imagyn Medical Technologies (Irvine, California), a developer of internal bioelectrical impedance technology, last month received 510(k) clearance to market its ECOM endotracheal cardiac output monitor in the U.S. The approval permits use of the system in patients who are orally intubated for an expected duration of 24 hours or less. ECOM is designed to measure cardiac output the volume of blood that the heart is able to pump per minute through an endotracheal tube, which is used to keep a patient's airway clear during the administration of anesthesia. The ECOM tube is characterized by an array of small electrodes imbedded on the balloon cuff that anchors the tube in the trachea. Once the tube is placed in the patient's airway, the company said the electrodes reside, anatomically speaking, "right around the corner from the ascending aorta, which is an ideal location from which to measure cardiac output." The system's electrodes sense the changes in electrical current with the arterial blood pumped for the heart. A proprietary algorithm in the system's software converts these changes into cardiac output, which is displayed on a bedside monitor for the anesthesiologist and surgeon to read.
Medical Services International (Edmonton, Alberta) said that through a subsidiary and with the help of International Product Services it has completed the registration of its VScan Rapid Diagnostic Test Kits for HIV1 and HIV2 in Vietnam and has received a license to be able to sell the VScan HIV 1 and 2 test kits in Vietnam.
Medtronic (Minneapolis, Minnesota) said it is distributing a Health Insurance Portability and Accountabilty Act-ready version of the Medtronic Paceart System that incorporates several new features designed to empower clinics to protect the privacy of patient data. The Paceart System is an arrhythmia information management system that allows clinicians to efficiently organize historical data about a patient's heart rhythm and the performance of his or her implanted device, which can contribute to a clinician's ability to make well-informed decisions about patient care needs. Medtronic also reported European regulatory approval of the Gatekeeper Reflux Repair System, a treatment for gastroesophageal reflux disease that uses biocompatible prostheses to mimic a normal functioning barrier between the stomach and the esophagus. The Gatekeeper System consists of an endoscopic delivery system and individual prostheses made of a biocompatible material (similar to the substance used in a contact lens).
Microsulis' (Hampshire, UK) microwave endometrial ablation (MEA) system for the treatment of menorrhagia received a unanimous recommendation of approval from the FDA's Obstetrics and Gynecology Devices Panel last month. Other approved options to treat menorrhagia which is chiefly characterized by abnormal bleeding in the uterus include radio frequency-based systems, lasers and cryoablation technology. Microsulis' U.S. trial for the technology was compared to patients undergoing radio frequency. A total of 655 patients in 11 investigational sites were studied between 1994 and 2001. The company received a CE mark in the UK for MEA in 1996, and approval also has been granted by Canada and Australia. MEA has been performed in more than 15,000 patients, company officials told the panel. The trial showed that MEA had an 87% success rate at reducing uterine bleeding compared to an 83% success rate for radio frequency. No unexpected side effects were reported. Microsulis said it would limit initial treatment in the U.S. to women with a minimum uterine thickness of 10 mm measured though ultrasound.
Nellcor (Pleasanton, California), a unit of Tyco Healthcare (Exeter, New Hampshire), introduced its new line of NdGO Disposable Manual Resuscitators that includes models with a built-in INdCAP colorimetric CO2 detector. The company said the combination resuscitator bag/CO2 detector provides a convenient, cost-effective way for clinicians and first responders to meet current clinical guidelines requiring the use of CO2 detection during intubation. The presence of CO2 in exhaled breath helps ensure the endotracheal tube is placed in the trachea and not the esophagus during intubation. INdGO resuscitators come in adult and pediatric sizes, both with and without the integral INdCAP CO2 Detector.
Nikon Instruments (Melville, New York) reported the first in its new Digital Sight series of high-resolution, stand-alone, network-ready color digital cameras. The camera's 5 million pixel CCD offers scientific and industrial microscope users the ability to capture extremely precise, detailed images that can be seen at the camera's own IP address. The stand-alone DS-5M-L1 captures high definition images at 2560 X 1920 effective pixels and is equipped with a 6.3", high-definition LCD monitor and pre-programmed imaging modes specifically designed for photomicrography applications. The DS-5M-L1 also allows the user to establish custom settings and provides tool functions that allow for count-marking and range measurement between two points on a specimen. Pre-programmed image modes allow the user to achieve optimum results in every observation method without spending time re-setting the camera for every photo session. It also features thumbnail display, allows for text and pen input and offers researchers the ability to superimpose saved images over a live image, allowing for easy comparison.
Orthovita (Malvern, Pennsylvania) said it has completed patient enrollment in its first U.S. study to evaluate the use of Cortoss Synthetic Cortical Bone Void Filler in the treatment of vertebral compression fractures of the spine. The vertebroplasty technique was used in this pilot study. Cortoss is a high-strength, biocompatible, self-setting composite specifically engineered to mimic the characteristics of the human body's weight-bearing cortical bone. Cortoss is approved for marketing under a CE mark in Europe for use in the augmentation of vertebral compression fracture procedures caused by osteoporosis and invasive tumors. The pilot study involving 20 patients at three sites will assess the ability of Cortoss to provide both pain relief and improvement in function by restoring weight-bearing strength and stability to the fractured vertebra. During the trial, Cortoss was injected through the skin into the fractured vertebra in the augmentation procedure known as vertebroplasty. Administered using a pre-filled, unit dose disposable cartridge, Cortoss has the capacity to stabilize and provide immediate weight-bearing support to the spine, the company said. Results from the study will be used to develop a large-scale study for the treatment of vertebral compression fractures.
Smith & Nephew Endoscopy (Andover, Massachusetts), a subsidiary of Smith & Nephew plc, reported the launch of the DORAweb Surgical Documentation System (Digital Operating Room Application), a program that integrates with Smith & Nephew's 635 Digital Image Management System to generate complete patient surgical reports using interactive medical imaging database applications. The DORAweb System was created to advance current clinical reporting productivity and help facilities manage costs by facilitating the rapid generation of a variety of endoscopic procedure information into comprehensive patient operative reports. The application can be accessed from any Windows-compatible web browser. Using any endoscopic camera, surgeons can capture still, surgical images with the 635 Digital Image Management System and automatically transfer to the DORAweb System. High-quality digital images can be exported in industry-standard formats with the DORAweb System for review, printing and archiving. Surgical images can also can be managed with text and graphic annotations, selective review and labeling and can be printed through any networked printer.
STAAR Surgical (Monrovia, California) reported that the May issue of Cornea, the Journal of Cornea and External Disease, published the findings of a study comparing the results of laser-assisted in situ keratomileusis (LASIK) and implantable contact lenses (ICL). The article concludes that ICL is safer, more effective and appears to be a viable alternative to LASIK, which uses corneal refractive excimer lasers, in the treatment of moderate to high myopia. In the article, the postoperative results of 210 eyes implanted with the ICL are compared with the postoperative results of 559 eyes on which LASIK surgery was performed. After six months, the study indicated that 7% of ICL patients had gained two or more lines on the standard eye chart of BSCVA, while only 3% of LASIK surgery patients had gained two or more lines and 2% of LASIK patients had actually lost two or more lines on the chart. After six months, the predictability of the ICL procedure was much higher, with 90% of patients within 1 diopter of attempted correction and 65% within 0.5 diopters. LASIK surgery had statistically significantly less favorable results, with only 76% of patients within 1 diopter of attempted correction and 53% within 0.5 diopters after six months.
Suros Surgical Systems (Indianapolis, Indiana) said that women classified at high risk for breast cancer now have the chance to find the smallest breast abnormality at the earliest possible stage of development and have it biopsied in 30 minutes without leaving the magnetic resonance imaging (MRI) suite and without undergoing surgery for a diagnosis. The ATEC breast biopsy system has adapted its technology to become the first and only vacuum-assisted breast biopsy device on the market capable of use under MRI. The system performs effectively under MRI because it is pneumatically powered, or air-driven, making it usable in the presence of the magnetic imaging field. Tissue samples can be acquired every 3.5 seconds with the ATEC, 10 times faster than with other vacuum-assisted breast biopsy systems.
Vascular Solutions (Minneapolis, Minnesota) received FDA 510(k) clearance for the Vari-Lase endovenous laser procedure kit, used in endovenous laser therapy for reflux of the great saphenous vein, commonly referred to as varicose veins. While vein stripping is still performed on over 100,000 patients each year in the U.S., a new non-surgical procedure using endovenous laser energy to treat and close the diseased vein has emerged as a preferred alternative. Recent clinical data on endovenous laser therapy has demonstrated excellent clinical results and outstanding patient satisfaction compared to surgical vein stripping.
W. L. Gore & Associates (Flagstaff, Arizona) and Medinol (Tel Aviv, Israel) reported the results of the NIRTOP clinical study conducted by Medinol. The multi-center study was conducted in 15 sites worldwide and included 305 patients. Medinol said the trial results confirm the clinical superiority of the Nirflex Stent. The stent has the lowest late loss rate of 0.65 mm a figure lower than any other bare-metal stent, the company said. Average reference vessel diameter in the study was 2.74 mm (2.5 mm-4.0 mm). Target lesion revascularization rate was in the single-digit range 4.4% at 180 days, 7% at 210 days and 8.9% at 270 days. The companies said these results position the Nirflex as the best-performing bare metal stent in the marketplace. esults of the NIRTOP trial were presented during a Medinol/Gore-sponsored symposium at the EuroPCR conference in Paris.