As part of its ongoing association studies in several cardiovascular indications, Celera Diagnostics (Alameda, California) has presented data linking genetic variations in two genes with increased risk for myocardial infarction (MI), commonly known as heart attack. The presentation on the study, conducted in collaboration with researchers from the Cleveland Clinic Foundation (Cleveland, Ohio) and the University of California, San Francisco, was made at the International Vascular Biology Meeting in Toronto, Ontario.

Myocardial infarction was one of the first areas that Celera Diagnostics began to examine in association studies in late 2002, it said.

"We think that the ability to predict risk for deaths from a first heart attack is an unmet medical need in the sense that while there are certain known or standard risk factors like smoking, high blood pressure or being overweight or[having] high lipids," Tom White, PhD, chief scientific officer at Celera Diagnostics, told Cardiovascular Device Update, "[but] they don't account for all the heart attacks that occur in people who may have genetic risk factors."

In fact, White said, it is believed that about 40% of all first heart attacks occur in people without a known risk factor, and about one-fourth of those heart attacks are fatal. So people without the common risk factors may be walking around at risk for a fatal heart attack without even being aware of their danger.

The two genetic markers, or single nucleotide polymorphisms, presented in Toronto include a SNP in the aquaporin 10 gene (AQP10), which is associated with a two-fold increased risk for MI, the company said. The second SNP is in KIAA1462, a gene of unknown function. Celera Diagnostics said that each of these SNPs "confers a risk for MI comparable to conventional risk factors."

Elsewhere in the product pipeline:

Advanced Magnetics (Cambridge, Massachusetts) reported the presentation of data on ferumoxytol, the company's investigational magnetic resonance angiography (MRA) contrast agent, at the American Society of Neuroradiology meeting in Seattle, Washington, last month. Clinical investigators presented data on the use of ferumoxytol-enhanced MRA to measure carotid artery disease. The authors reported that ferumoxytol "provided excellent delineation" of the carotid arteries in patients and volunteers and concluded that "ferumoxytol-enhanced MRA has the potential to improve the accuracy and precision of measurements of carotid artery disease compared with current MRA methods." Ferumoxytol is currently in Phase II clinical trials for use as a contrast agent in MRA.

Akers Biosciences (Thorofare, New Jersey) said it has received FDA clearance for its rapid test for Heparin/Platelet Factor-4 (HPF-4) antibodies. The HealthTEST HPF4 Antibody Assay is designed to identify patients at risk for developing heparin-induced thrombocytopenia and thrombosis syndrome, a severe allergic-like side effect associated with the use of the anticoagulant heparin. The company said it would market the HealthTEST HPF4 to hospitals where heparin is administered during surgical and other medical procedures. The rapid manual assay can be easily performed when immediate results are required.

Angiotech Pharmaceuticals (Vancouver, British Columbia) has completed enrollment in its vascular wrap study, nearly six months earlier than anticipated. The company began enrollment in the trial last October. Patients suffering from poor blood flow to the legs often have surgery to bypass the plaque that obstructs the artery. Typically a vein, artery or synthetic graft is sewn into the blocked artery in front of, and just beyond the obstruction, allowing blood flow to circumvent the diseased area. Unfortunately, the sites where the graft is attached to the artery called the anastomosis are subject to scarring and narrowing, also known as stenosis, leading once again to compromised blood flow and causing pain, disability or potentially even loss of the limb. Angiotech has developed a treatment solution to prevent the obstructing scar from forming at the site of the bypass connection. The study involves the placement of paclitaxel wraps around the distal anastomosis (i.e., the anastomosis downstream from blockage or the one farthest down the leg) in patients needing implantation of a synthetic bypass graft.

Bayer HealthCare Diagnostics (Tarrytown, New York) said its BNP (B-type natriuretic peptide) test for cardiac patients has received FDA approval for two additional claims: the prediction of survival in patients after myocardial infarction in conjunction with other risk factors, as well as assessment of heart failure severity in patients diagnosed with congestive heart failure (CHF). Bayer's BNP test originally received FDA clearance in June 2003 for a fully automated test for use in the diagnosis of acute coronary syndrome. Bayer said that there are "significant differences" in the BNP values in normal individuals vs. heart failure patients in all four New York Heart Association (NYHA) classifications for CHF, including the least-severe Class I. The proportional increase in BNP concentration is approximately twofold as heart failure severity increases from Class I to II, II to III, III to IV, the company said. "This differentiation led to the FDA clearing the Bayer BNP test as a tool in the assessment of severity in heart failure patients." The BNP test has a greater than 99% negative predictive value in ruling out heart failure, Bayer said.

Biophan Technologies (Rochester, New York) reported details of a study on pacemaker safety released at the Heart Rhythm Society annual meeting in San Francisco, California, in May. The study indicated that a standard pacemaker lead, attached to a pacemaker, will heat up at temperatures varying from as low as 2.2 degrees C to as high as 29.2 degrees C in a standard magnetic resonance imaging (MRI) machine. Examination of the pacemaker electronics revealed that the exposure to the MRI procedure introduced several anomalies into the operation of the pacemaker, which also could interfere with proper pacemaker performance. The study also evaluated several of Biophan's solutions to the heating problem, including an RF filter, which consistently reduced the heating to within acceptable FDA guidelines under all MRI test conditions.

Cambridge Heart (Bedford, Massachusetts) reported the receipt of patent No. 6,735,466 from the U.S. Patent and Trademark Office, titled "Analytical signal method for analysis of T-wave alternans." The company also received a notice of allowance for the patent from the European Patent Office. Cambridge Heart's Analytical Spectral Method is a digital signal processing component of its core microvolt T-wave alternans technology. It further enables the accurate analysis of the patient's electrocardiogram for the identification of individuals at risk of sudden cardiac death.

CardioGenesis (Foothills Ranch, California) reported that a team of physicians who have performed and developed a variety of approaches to transmyocardial revascularization (TMR) concluded in an article featured in the June edition of The Heart Surgery Forum that TMR is a clinically proven, safe and effective therapy for addressing some of the most difficult angina and revascularization cases. "Minimally invasive approaches, including off-pump approaches and limited thoracotomies to enhance patient benefit and expand patient eligibility, are becoming a routine part of TMR strategy," said study author Louis Samuels, MD. "Future applications in this regard include the use of port access to minimize patient pain and recovery time and to avoid sternotomy in young patients."

Cholestech (Hayward, California) reported FDA clearance of its High Sensitivity C-Reactive Protein (hs-CRP) test. The American Heart Association and the Centers for Disease Control and Prevention recommend that in individuals determined to be at intermediate risk of coronary heart disease, measurement of hs-CRP may help direct further evaluation and therapy in the primary prevention of cardiovascular disease. The new hs-CRP test cassette can be used on the company's existing Cholestech LDX System once a simple software upgrade has been completed. The clearance will allow the company to market the product to moderately complex laboratories in the coming months once scale-up of the manufacturing process is completed. Cholestech also said it plans to seek CLIA-waived status for the hs-CRP test.

The FDA has cleared Cook's (Bloomington, Indiana) next-generation Zenith Flex AAA Endovascular Graft for U.S. distribution. The company also released two-year data on the original Zenith abdominal aortic aneurysm (AAA) device, which was cleared by the FDA last year. According to Cook, the Zenith Flex AAA graft system features several significant innovations over the previous iteration of the Zenith device originally approved for sale in the U.S. in May 2003. These advanced features include more widely spaced stent bodies to allow the device to conform to tortuous anatomy. The new design also decreases the Zenith FLEX stent-graft's kink radius by 40% to 68%, allowing the device to bend around tighter turns in the aorta with less chance of kinking. Before market launch of the new Zenith endograft, the company said it is waiting to receive FDA clearance on a new delivery system that takes full advantage of the endograft's advanced features. The next-generation H&L-B One Shot delivery system features Cook's new Captor Hemostatic Valve to inhibit blood reflux and air aspiration. It also features a Flexor introducer that uses a unique sheath construction to combine optimal flexibility with maximum resistance to sheath kinking or compression.

Digirad (San Diego, California) reported the introduction of its Cardius-1M system, which it said represents a significant advance in nuclear cardiac imaging by offering physicians greater flexibility through an upgradeable mobile platform that is expandable with evolving practice needs. The Cardius-1M system is comprised of a solid-state nuclear gamma camera, an upright imaging chair, an acquisition/processing station, and Digirad's third-generation Solidium solid-state detector. The lightweight system offers a small footprint, which allows it to fit into a 7 foot x 8 foot space without the need for room renovations. The company said the upright and open architecture of the patient chair used with the Cardius-1M system can increase patient comfort and reduce the incidence of claustrophobia. The Cardius-1M system is designed for compatibility with other Cardius series imagers.

LuMend (Redwood City, California) said it is launching the Frontrunner XP Chronic Total Occlusions (CTO) Catheter platform as part of its new peripheral vascular strategic initiatives. The XP family of catheters is based on the Frontrunner X39 coronary CTO Catheter and is designed to provide enhanced performance in crossing occlusions in the peripheral vasculature. The new 4.5 Fr Frontrunner XP CTO Catheter is designed to address the demands associated with the specific anatomical and lesion characteristics often found in the peripheral vasculature. The XP, which can be delivered through a 6 Fr guide catheter, incorporates a more flexible shaft designed to optimize delivery performance, enhanced tip shape-ability and an improved polymer formulation designed to improve handling and crossing performance. The XP is available in lengths of 90 cm and 140 cm.

Medtronic (Minneapolis, Minnesota) reported that it has launched the InSync cardiac resynchronization therapy system in Japan, bringing a new therapy for people suffering from heart failure to another major global market. InSync is an implantable device about the size of three large stacked coins that helps resynchronize the left and right sides of the heart so that it pumps blood more efficiently. Medtronic said it is the only company offering cardiac resynchronization therapy to patients with heart failure in Japan. Separately, Medtronic reported the European market release of the InSync Sentry cardiac resynchronization therapy defibrillator (CRT-D). Medtronic said the InSync Sentry is the first CRT-D device with automatic fluid status monitoring, which can be programmed to alert patients and clinicians to changes in fluid accumulation in the lungs and thoracic cavity. The OptiVol Fluid Status Monitoring feature measures changes in intra-thoracic impedance, an indication of a patient's changing fluid volume. Physicians set a threshold for each patient, and when the threshold is crossed, the patient and clinician are alerted, providing for the possibility of earlier clinical assessment. InSync Sentry offers a small size (40 cc), with increased longevity and delivers 35 joules of energy. The device maintains cardiac resynchronization therapy during changing patient conditions.

Possis Medical (Minneapolis, Minnesota) reported that it has received two marketing clearances from the FDA. The AngioJet Xpeedior 120 catheter and the AngioJet Power Pulse Spray Ancillary Kit have been cleared for the infusion of physician-specified fluids into the peripheral vascular system. The FDA also cleared the 0.014" GuardDOG Occlusion Guide Wire System for use in the peripheral vasculature to facilitate the infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. The company expects both of these products to undergo initial market testing at a limited number of clinical sites during the current fiscal quarter, and they are expected to be in full commercial release beginning in August.

QRS Diagnostic (Plymouth, Minnesota) reported that the U.S. Patent and Trademark Office approved a new patent on its design of medical devices contained in computer cards. U.S. patent No. 6,712,762 is a continuation of patent No. 6,159,147, which QRS received in December 2000. QRS uses its patented technology to encode the intelligence of physiological data acquisition and analysis into computer cards, used in spirometry, pulse oximetry, diagnostic electrocardiography and blood pressure monitoring.

Rafael Medical Technologies (Dover, Delaware) has received CE mark approval for the SafeFlo Retrievable Vena Cava Filter for the prevention of pulmonary embolism as well as for the VascuGrasp Retrieval System, a foreign body retrieval device used to remove the SafeFlo filter from the vena cava. The SafeFlo filter is based on shape-memory Nitinol wires and a design that provides an alternative anchoring mechanism to the standard strut-based filter design. SafeFlo's low-profile, vessel-friendly design affords simple and safe filter implantation with the ability to fully deploy, retrieve and reposition prior to detachment, the company said. As a retrievable or "optional" filter, SafeFlo has been demonstrated to be fully retrievable up to 21 days post-implantation. Rafael Medical said it expects to launch SafeFlo and VascuGrasp in selected European markets later this year.

Revivant (Sunnyvale, California) reported that five centers are participating in the AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial to evaluate the safety and effectiveness of its AutoPulse Resuscitation System, an FDA-approved external device that is portable and designed to provide consistent automated chest compressions during cardiopulmonary resuscitation. During the one-year study, half of the patients will receive manual chest compressions and the other half will receive compressions with the AutoPulse. Patients who survive and agree to continue to participate in the study will be followed for three months after the event. At the conclusion of the study, the researchers will compare the two methods to see which group of patients had a better outcome.

Spectranetics (Colorado Springs, Colorado) said it has received conditional approval from the FDA to begin the Extended FAMILI clinical trial, which will study the use of the company's excimer laser catheters to treat heart attack patients. The goal of the study is to determine if treating the heart attack with the laser restores blood flow and reduces the infarct size. The feasibility trial will enroll 80 patients at up to 20 multinational sites. The trial has been initiated in Europe, and 13 patients have been enrolled at five sites. For each patient, study endpoints include the re-establishment of blood flow in the blocked artery creating the heart attack, the ability of blood to flow into the heart muscle as seen on the electrocardiogram and the amount of tissue damaged by the heart attack.

St. Jude Medical (St. Paul, Minnesota) said the FDA has approved a premarket approval supplement creating new labeling for the Angio-Seal vascular closure device. The new labeling allows clinicians to re-stick 1 cm proximal to the same location of a previous Angio-Seal device in less than 90 days. The labeling change is based on a study published in the February 2003 Catheterization and Cardiovascular Interventions. The company also reported shipment of the 4 millionth Angio-Seal device in May, which it said is continued evidence that active vascular closure is becoming a worldwide standard of care.

Toshiba America Medical Systems (Tustin, California) reported that it has received FDA marketing clearance for its C-panel flat-panel detector (FPD). Designed specifically for cardiac imaging, C-panel FPD technology delivers high-resolution dynamic imaging for cardiovascular intervention and diagnostic exams, while also providing greater flexibility for dose reduction. The C-panel FPD is a field-upgradeable component for Toshiba's Infinix CC-i System.

Trimedyne (Irvine, California) reported the issuance of U.S. patent No. 6,740,107, which covers new, minimally invasive laser devices designed to treat mitral valve regurgitation. Trimedyne's patent covers designs for two new laser devices to treat this condition; one for use by surgeons during bypass surgery, and one for use by cardiologists in the cath lab through a puncture in an artery in the groin.

Vasamed (Minneapolis, Minnesota) reported that the U.S. Patent and Trademark Office granted it a method patent for a new pulse oximeter that incorporates signals from a laser Doppler velocimeter (LDV) and an impedance cardiograph (ICG) to accomplish the measurement of oxygen saturation. Both LDV and ICG are used in products owned by Vasamed.

Ventracor (Sydney, Australia) said several hospital ethics committees in Australia and New Zealand are currently reviewing the final protocols for the CE mark trial of its VentrAssist implantable left ventricular assist system, with agreements expected in May and June. In the UK, clearance from the government's regulatory authority, in addition to the Ethics Committee approval, is required to start the trial. The company said an additional submission is currently being finalized.

Zoll Medical (Chelmsford, Massachusetts) said the FDA has granted marketing clearance for the new pediatric capability in its automated external defibrillator, the AED Plus. This capability, for children up to 8 years of age, is now available to customers and distributors in the U.S. and worldwide. The pediatric capability includes voice prompts that tell rescuers what type of electrodes are connected, so that the proper electrodes are used for adults or children. Separate and specific algorithms for adults and children are used to analyze a victim's heart rhythm. Pediatric-specific energy levels also have been incorporated. Electronics in the AED Plus adjust defibrillating energy levels automatically so that suitable doses, when needed, are delivered.

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