Vasomedical (Westbury, New York) said last month that it has begun a patient enrollment for a large multicenter, randomized, controlled trial on the efficacy of its Enhanced External Counterpulsation (EECP) system in patients with congestive heart failure (CHF). The Prospective Evaluation of EECP in Congestive Heart Failure (PEECH) trial, which will evaluate improvements in exercise capacity and quality of life, as well as the reduction in the need for certain medications that CHF patients are typically prescribed, is being conducted as part of an FDA-approved investigational device exemption (IDE) protocol. The company said the PEECH trial is expected to enroll 180 patients at 18 centers across the U.S. and take up to two years to complete, including a 6-month patient follow-up phase.
Results of an earlier 32-patient feasibility study were presented at the Heart Failure Society of America's annual meeting in September 2000. That study, designed to evaluate the safety of EECP in treating congestive heart failure, showed a sustained improvement in exercise capacity and quality of life in CHF patients immediately after and at six months following a course of treatment.
Vasomedical's EECP device is a noninvasive, outpatient therapy for the treatment of diseases of the cardiovascular system. It is a microprocessor-based device that delivers what it terms a "retrograde" arterial pressure wave to the heart. The company said this increases coronary perfusion and reduces ventricular overload. The treatment is seen as a means of offering relief to angina sufferers who no longer respond to medication or are poor candidates for invasive revascularization procedures such as bypass surgery or balloon angioplasty. The therapy serves to increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function.
During EECP therapy, a patient lies on a bed while wearing three sets of inflatable pressure cuffs, resembling oversized blood pressure cuffs, on the calves, the upper and lower thighs and buttocks. The cuffs inflate sequentially via computer-interpreted ECG signals, starting from the calves and proceeding upward during the resting phase of each heartbeat (diastole). When the heart pumps (systole), all three cuffs instantaneously deflate. This sequential squeezing of the legs creates a pressure wave that forces blood from the legs to the heart. This surge of circulation supposedly insures that the heart does not have to work as hard to pump large amounts of blood through the body, and that more blood is forced into the coronary arteries, supplying energy to the myocardium.
D. Michael Deignan, president and CEO of Vasomedical, said, "[This trial] is a crucial step toward establishing EECP as a vital, cost-effective option for treating CHF patients and expanding its applications beyond our core angina market."
The trial follows close on the heels of results of two other studies released during the American College of Cardiology (ACC, Bethesda, Maryland) meeting in March. The company said the results of those studies showed sustained angina relief with EECP therapy up to one year following treatment. It said those results confirmed earlier studies on the duration of benefit derived from EECP, and were among several studies presented demonstrating the effectiveness of EECP in treating coronary artery disease.
The precise mechanism of action is unknown, but Vasomedical says there is strong hypothetical evidence to suggest that EECP triggers a neuro-hormonal response that induces the production of growth factors and dilates existing blood vessels, thus fostering angiogenesis, the development of new collateral blood vessels. These tiny collateral vessels, it is theorized, then bypass current blockages and feed blood to areas of the heart that are receiving an inadequate supply.
Elsewhere in the product pipeline:
Affymetrix (Santa Clara, California) was granted a U.S. patent covering nucleic acid array scanners. The patent, titled, "Signal Detection Methods and Apparatus," encompasses an apparatus for detecting nucleic acids on a support containing oligonucleotides, polynucleotides or nucleic acids. It also covers a method of determining whether a fluorescently labeled nucleic acid binds to one or more different sequences at known locations, irrespective of the apparatus.
Agilent Technologies (Palo Alto, California) and Pulsion Medical Systems AG (Munich, Germany) received FDA 510(k) clearance of a jointly developed hemodynamic assessment tool based on Pulsion's established PiCCO technology. As part of a global alliance, Agilent and Pulsion have agreed to market a continuous cardiac output measurement technology, which is integrated into the latest release of the Agilent CMS 2001 acute care patient monitors. This continuous approach to hemodynamic monitoring introduces a new method for cardiac status and vascular volume monitoring, making these measurements available to a wider patient population, including small children. Because PiCCO requires only a central venous and an arterial catheter, the method avoids complications associated with right heart catheterization, according to the companies. The PiCCO method delivers information on cardiac output as well as hemodynamic parameters such as intrathoracic blood volume, which enables the user to guide fluid therapy.
Arrow International (Reading, Pennsylvania) said that two additional patients have received a LionHeart implant, the company's fully implantable Left Ventricular Assist System (LVAS). One patient received the device in Bad Oeyenhausen, Germany, where a total of six devices have now been implanted. The second patient received the device at the University of Pennsylvania Medical Center (Philadelphia, Pennsylvania) in mid-April. This was the second patient to enter the seven-patient U.S. feasibility trial authorized under an FDA investigational device exemption. The first U.S. recipient of the LionHeart received the device on Feb. 28 at Penn State Milton S. Hershey Medical Center (Hershey, Pennsylvania). This patient is progressing toward recovery following a second surgery for a condition unrelated to the functioning of the LionHeart. The company said that the device, which is capable of taking over the entire workload of the left ventricle, represents a significant advance in mechanical circulatory assist technology. Because the Arrow LionHeart is the first fully implantable "destination therapy" device, the patient is likely to experience an improved quality of life for an extended period of time. It is fully implanted in the body and does not replace the heart, but assists in the pumping function of the heart's left ventricle. The device is electrically driven by a wearable battery pack that transmits power non-invasively through the skin to charge internal batteries and power the blood pump.
BioCurex (Rancho Santa Margarita, California) recently introduced Histo-Recaf, its first diagnostic product for the detection of malignant cancer in tissue specimens or biopsies. The diagnostic kit is based on technology that the company said allows the differentiation of cancer cells from normal cells, as well as differentiating malignant tumors from benign tumors. The first test kits are being produced at BioCurex and will continue to be tested in the near term at international cancer centers. BioCurex has developed technology in the areas of cancer diagnosis, tumor imaging and therapeutics. The technology identifies a universal cancer biomarker or receptor known as RECAF, thereby allowing detection of malignant cancers from blood tests or tissue biopsies, said the company. The technology can also be used to image the location of the cancer and improve the present detection systems.
Boston Medical Technologies (Wakefield, Massachusetts) revealed the results of a study on heart rate variability (HRV) testing. According to Diabetes Technology and Therapeutics, Volume 3, Number 1, HRV is considered to be the most reliable and available indicator of autonomic nervous system function. The study, "Heart Rate Variability Measurement in Diabetic Neuropathy: Review of Methods," also reports reproducibility and normal ranges for the Anscore Health Management System, the company's system for quantifying HRV. The Anscore Health Management System was evaluated in a study on 212 healthy individuals, aged 20-80, who performed three standard heart rate variability tests: Metronomic Breathing, Valsalva and Stand. The system garnered normal range results that the company said illustrate the importance of having machine-specific reference values so that reliable test results can be obtained. The study also demonstrated the system's ability to pinpoint subtle decreases in HRV as a person ages. The company said there is a consensus on the use of HRV as a recommended component in the routine screening of autonomic dysfunction and for monitoring the progress of autonomic neuropathy. Boston Medical Technologies is developing office and hospital-based, noninvasive heart rate variability testing systems.
Cambridge Heart (Bedford, Massachusetts) and St. Jude Medical (St. Paul, Minnesota) have reported the launch of a new trial that will measure the ability of Cambridge Heart's Microvolt T-wave Alternans (TWA) technology to determine those candidates best suited for implantation with a cardioverter defibrillator (ICD). The specific endpoint of the prospective, multicenter trial, termed Alternans Before Cardioverter-Defibrillator (ABCD), is to determine whether the noninvasive TWA test is comparable to an invasive electrophysiology (EP) study in predicting the risk of life-threatening ventricular tachyarrhythmic events in patients meeting the criteria for ICD therapy. If this is proven, the broader implication for the ABC trial is that TWA testing could be used as an early warning signal supporting the need for ICD implantation and, further out, push increasing use of that life-saving therapy.
Cyberonics (Houston, Texas) said that results of a preliminary study show that vegus nerve stimulation (VNS) therapy may effectively normalize sleep abnormalities in depressed patients. Results of the study, led by Dr. Roseanne Armitage of the University of Texas Southwestern Medical Center (Houston,
Texas), were to be presented at the annual meetings of the American Academy of Neurology, the American Psychiatric Association and the Society of Biological Psychiatry. Four treatment-resistant depressed patients were evaluated once prior to implantation and again after receiving 10 weeks of VNS therapy with Cyberonics' NeuroCybernetic Prosthesis System. After receiving VNS, all of the study participants showed improvements in sleep disturbance, including decreased non-restorative Stage 1 sleep and intermittent wakefulness and increased Stage 2 restorative sleep.
Data Critical (Bothell, Washington) released its RhythmView, an integrated arrhythmia monitoring hardware and software package. The system allows cardiologists to set up a comprehensive 24-hour arrhythmia monitoring station in their office or hospital cardiac department, reducing, said the company, the need for outside arrhythmia monitoring services. RhythmView also provides cardiologists instant, mobile access to EKGs and patient data on a Compaq iPAQ Pocket PC. Based on the Paceart 2000 pacemaker follow up system, the RhythmView system integrates Data Critical's Paceart Division's Arrhythmia Management and CardioVoice monitoring software with patient event recorders and Compaq hardware, including the iPAQ. Data Critical makes wireless and Internet systems for communicating critical health care data.
Diametrics Medical (Anaheim, California) and Agilent Technologies (Palo Alto, California) have jointly developed a point-of-care diagnostics (POCD) information management system. The POCD information management system involves the integration and storage of data into the portable IRMA POCD instrument, or integrated into an Agilent multiparameter monitor by a Vuelink connection. Information includes patient test, date and time, operator and patient ID, oxygenation parameters and quality control (QC) results. Data can be uploaded from the care unit (or remote locations) through various connectivity options (Ethernet network, serial, modem or a combination) into the IRMA Data Management System (IDMS). IDMS also serves as a gateway to host systems, using automatic customized interfacing to upload patient test data to laboratory, clinical and hospital information systems. Agilent is the exclusive worldwide distributor for IDMS, which is manufactured by Diametrics.
Eclipse Surgical Technologies (Sunnyvale, California) said that its laser heart revascularization procedure won an important endorsement as a proven health benefit for patients from the Blue Cross and Blue Shield Association. Eclipse received confirmation from the Blue Cross/Blue Shield Technology Evaluation Center that the transmyocardial revascularization (TMR) laser procedure, "improves net health outcomes" when performed as an adjunct to coronary artery bypass graft surgery. In FDA-approved TMR, surgeons use a laser to drill a series of tiny holes in the heart muscle which are believed to stimulate new blood flow to the diseased area.
Enterix (Falmouth, Maine) reported the U.S. launch of !nSure FOBT, a new immunochemical fecal occult hidden blood test, at the Digestive Disease Week meeting in Atlanta, Georgia. !nSure is an immunochemical fecal occult blood test (FOBT) that detects occult blood originating in the colon and rectum. Tests for fecal occult blood are the only method of screening for colorectal cancer and pre-cancerous polyps that has been demonstrated in large-scale randomized clinical trials to reduce the incidence, morbidity and mortality associated with colorectal cancer. !nSure FOBT was designed to address the compliance-limiting deficiencies of existing FOBTs, the company said. The test is immunospecific for the globin portion of human hemoglobin, thereby avoiding false positive results caused by cross-reactive foods and upper gastrointestinal bleeding.
Guidant (Indianapolis, Indiana) implanted its first Contak Renewal system, what it termed "its most advanced heart failure therapy system." The device contains new diagnostic capabilities that are designed to help physicians better manage their patients' condition by capturing information that is relevant to physician decision-making. The device monitors heart rate variability, a tool designed to track and measure the status of heart failure patients. Additionally, the system uses data from an accelerometer sensor to track trends in patients' activity levels. Raymond Yee, MD, director of arrhythmia services at London Health Science Center (London, Ontario) performed the first implant of the device, in a 72-year-old woman suffering from idiopathic dilated cardiomyopathy. The device provides cardiac resynchronization therapy, which is designed to enhance pumping function, and defibrillation capability. Guidant also said it has received FDA approval for the Omnilink .018 Biliary Stent System. That approval came less than a month after Guidant received FDA approval of the RX Herculink Plus Biliary Stent System. The Omnilink is intended for the treatment of malignant biliary obstructions – blockages that form in ducts that carry fluids from the liver to the gallbladder or from the gallbladder to the small intestine.
Medwave (St. Paul, Minnesota) said it has released High Motion Tolerant (HMT) software for its Vasotrac Continual Non Invasive Blood Pressure Monitor. The technology means that accurate blood pressure values now can be obtained when the patient is moving or being moved. The HMT was demonstrated using a treadmill at last month's North American Society of Pacing and Electrophysiology meeting in Boston, Massachusetts. Medwave said that even slight movements can create significant challenges for the caregiver when attempting to obtain blood pressure values, especially with a cuff, but with the HMT software, a patient can be literally walking or jogging and still obtain accurate readings that are consistent, approximately every 15 heartbeats. Vasotrac is designed for measuring a patient's blood pressure on a continual basis. Medwave also said that Children's Hospital (Boston, Massachusetts) will perform a clinical study of the company's Vasotrac APM205A Continual Non-Invasive Blood Pressure Monitor, on children with cardiovascular concerns. Medwave recently submitted the Vasotrac to the FDA for 510(k) review allowing the company to market the Vasotrac specifically for pediatric use. That followed a study that was completed at Arkansas Children's Hospital (Little Rock, Arkansas). The purpose of the study is to provide further validation of the use of the Vasotrac APM205A CNIBP Monitor in use with children. The Vasotrac will be compared to the "gold standard" arterial catheter and traditional noninvasive blood pressure cuff that is found in many bedside patient monitoring systems and presently used with children. The Vasotrac is designed to measure a patient's blood pressure on a continual basis, with updates available approximately every 15 heartbeats. It is being marketed in several countries, including the U.S. for adult patients.
Meridian Bioscience (Cincinnati, Ohio) said it has filed both a U.S. patent application and an international application under the Patent Cooperation Treaty directed to the diagnosis of Helicobacter pylori-associated colic in infants and its treatment with antibiotic and other therapies. H. pylori infection has also been implicated in gastroduodenal diseases such as peptic ulcers, gastritis and stomach cancer. Meridian said it has been able to clearly demonstrate the correlation between H. pylori infection and colic symptoms in infants.
Micro Motors (Santa Ana, California), a division of Pro-Dex, a medical and dental products company, said it has successfully launched a battery-powered cranial screwdriver in conjunction with an exclusive three-year agreement it has entered into with a manufacturer and marketer of cranial-maxillofacial screws and plates used in cranial and facial surgery. Micro Motors said that the new screwdriver would replace the manual drive system currently used, enabling surgeons to more reliably place screws and plates during delicate reconstructive surgery.
Microsemi (Irvine, California) has launched a line of second-generation silicon carbide power Schottkys for use in niche commercial power applications, including implantable medical electronics and broadband base stations. The UPSC100 and UPSC200 Schottky rectifiers are rated at 100- and 200-volts, respectively. The company said these latest power products result from its developmental program designed to merge its Powermite packaging with the core strengths of silicon carbide. Microsemi said it will introduce a new line of silicon carbide Schottkys for use in implantable cardioverter defibrillators and other applications.
Myocor (Maple Grove, Minnesota) reported the first U.S. human implants last month of the Myocor Myosplint, an implantable device designed to improve cardiac performance and efficiency in heart failure patients by changing the size and shape of the heart. The first U.S. Myosplint patients were men diagnosed with Class III idiopathic dilated cardiomyopathy. The procedures were performed at the Cleveland Clinic Foundation (Cleveland, Ohio). In both procedures, three Myosplint devices, each of which consists of two pads that rest on the outside of the heart and are connected by a high-strength tension member, were placed down the length of the left ventricle. The device was used to draw the walls of the heart closer together, reshaping the heart and reducing its size by a prescribed amount. In both cases, the Myosplints were placed in approximately 45 minutes. The patients subsequently underwent procedures to repair leaking mitral valves and have since been discharged from the hospital. Up to 10 patients will receive Myosplint implants during a Phase I safety and feasibility trial authorized by the FDA and being conducted at the Cleveland Clinic Foundation and the University of Michigan Health System (Ann Arbor, Michigan). Myocor expects to begin a Phase II pivotal trial late this year. A European safety study began earlier this year, with a total of 14 human implants completed to date. The initial European implants were performed at University Heart Center (Leipzig, Germany) and Grosshadern Clinic (Munich, Germany). Heart failure affects about 13.5 million people in the U.S., Western Europe and Japan, with 1.4 million new cases diagnosed each year.
Nucletron BV (Veenendaal, the Netherlands), an international radiotherapy company, has received FDA clearance to begin marketing its new release of stereotactic planning software and multi-modality image fusion software for radiation therapy planning. Stereotactic radiosurgery is used for the treatment of small brain lesions where radiation therapy offers advantages over other treatment methods. The enhanced Nucletron radiosurgery planning software provides comprehensive and treatment planning for this complex and precise treatment method.
Odin Medical Technologies (Newton, Massachusetts) said research presented at the meeting of the American Association of Neurological Surgeons in Toronto, Ontario, shows that the most useful intraoperative magnetic resonance Imaging (iMRI) system brings good quality imaging where it needs to be – in the operating room – to the neurosurgeons who actually perform the procedures without restricting their access to the patient. In a comparative study of Odin's PoleStar N-10 iMRI and GE Medical Systems' Signa SP, neurosurgeon Rene Bernays, MD, of Zurich, Switzerland, reported that the PoleStar's dedicated neurosurgical system offers the power of real-time MR image guidance at less cost, high ergonomy and greater acceptance than its competition.
Ostex International (Seattle, Washington) has received U.S. patent No. 6,190,412, titled "TRAP-Coated Prostheses." The patent is directed to prosthetic devices, such as artificial joints and teeth, having hydroxyapatite-coated bone attachment surfaces to which tartrate-resistant acid phosphatase (TRAP) is adsorbed. It is believed that TRAP-induced stimulation of osteoclast recruitment results in osteointegration and enhanced bonding of the graft or prosthesis to the patient's natural bone. Ostex said it is investigating partnering with a larger company for further development and commercialization of the technology.
Phase Forward (Waltham, Massachusetts) has released the InFusion portal module as an extension to its InForm system, the standard platform for web-based clinical trial management. The InFusion portal links trial sponsors and investigators through a dynamic bi-directional information channel, facilitating the activities essential to building and managing Phase II and Phase III clinical studies. The InFusion portal delivers document management capabilities within a collaborative environment.
PhotoMedex (Radnor, Pennsylvania) said it has submitted a 510(k) application to the FDA to market the Xtrac laser system for the treatment of atopic dermatitis, or eczema. The company already has FDA approval to market the system for the treatment of psoriasis and vitiligo.
Possis Medical (Minneapolis, Minnesota) said the FDA has approved the re-start of patient enrollment in the TIME 1 (Thrombectomy In Middle Cerebral Artery Embolism) clinical trial for ischemic stroke, which is caused by blood clots occurring deep within the brain, resulting in death or substantially reduced quality of life. Possis has developed a highly miniaturized, flexible catheter, the NV150, to access the middle cerebral artery and rapidly remove clots. TIME 1 will enroll up to 30 patients at up to eight centers in the U.S. to determine safety of the device for that indication. As a result of the earlier treatment of five patients in TIME 1, there have been important refinements to both the device and to the trial protocol. The FDA has now approved these refinements.
Quantech (Eagan, Minnesota) said the Minneapolis Medical Research Foundation (MMRF; Minneapolis, Minnesota) has begun clinical studies of the Quantech FasTraQ instrument system and PrePaQ cardiac and pregnancy test cartridges in preparation for submission to the FDA. The FasTraQ system is designed to enable emergency department personnel to generate time-critical diagnostic test results on site in 10 to 15 minutes, rather than having to go through the more time-consuming process of sending test samples to the hospital's laboratory. The MMRF, which oversees research at Hennepin County Medical Center, will use two of Quantech's PrePaQ test cartridges in the studies – one containing a panel of the cardiac-marker tests, myoglobin, CK-MB and troponin-I, and one containing hCG, a test for the quantitative determination of pregnancy. Two blood samples will be drawn from each patient tested, with one sample going to the hospital laboratory and the other tested in the FasTraQ system. The results will then be compared in a statistical analysis. Quantech is completing development of its FasTraQ Emergency Department (ED) Patient Treatment Information Platform. The core of this platform is a diagnostic system that uses its proprietary surface plasmon resonance technology. The company has received clearance from the FDA to market for clinical use its tests for the cardiac enzymes myoglobin and CK-MB and the pregnancy enzyme hCG.
Quidel (San Diego, California) reported FDA clearance of its QuickVue Dipstik Strep A test. The new test is Quidel's first dipstick-style Strep A test and adds to the company's existing portfolio of Strep A tests, which includes the QuickVue In-Line Strep A test, QuickVue Flex Strep A test and the CARDS O.S. Strep A test. Quidel is a provider of point-of-care rapid diagnostic tests.
St. Jude Medical (St. Paul, Minnesota) reported the release of new electrophysiology catheters and guiding introducers that can assist clinicians in the diagnosis of paroxysmal atrial fibrillation. The 4 Fr Supreme Spiral SC catheters are deployed into the left atrium via specialized Fast-Cath Duo guiding introducers allowing physicians to circumferentially map the ostia of the pulmonary veins. St. Jude said the catheter's spiral-shaped curve tips can assist the physician in identifying preferential entrance or exit points where atrial fibrillation propagates into the left atrium. The new catheter system allows two catheters to be deployed through a single transseptal puncture for the simultaneous mapping of a set of pulmonary veins. The company also received premarket approval from the FDA for its Microny II SR+ AutoCapture Pacing System, which it said is the world's smallest pacemaker. Launch of the single-chamber, rate-responsive pacemaker will begin immediately, according to St. Jude, which also reported FDA approval of the Microny K SR pacemaker, a dedicated unipolar, single-chamber, rate-responsive device.
Stryker (Kalamazoo, Michigan) said the European Commission has granted marketing authorization for Osteogenic Protein 1 (OP-1) in the 15 member countries of the European Union. Osteogenic Protein 1 is Stryker's patented recombinant human protein, which induces bone formation. The approved product is a combination of the OP-1 protein and a collagen carrier. The product is wetted to form a paste that is surgically implanted into the bone defect. In Europe, the approved indication is for treating nonunion of the tibia of at least nine months duration, secondary to trauma, in skeletally mature patients, in cases where previous autograft has failed or use of autograft is unfeasible. Commercial launch of the product in the European Union is expected to begin in 3Q01.