By OMAR FORD
CD&Ds

Two new abstracts bolster CardioNet's (Conshohocken, Pennsylvania) CardioNet System's use to be expanded for the detection of atrial fibrillation (AF).

According to the studies, the system has the ability to detect clinically significant events in patients following ischemic stroke or surgical AF ablation procedures.

CardioNet reported the release of its new AF reporting package to enhance its current AF Management Program last October. The system offers a tool to physicians for the diagnosis, treatment and management of their AF patients. It also additionally provides physicians with a monitoring program to evaluate the clinical efficacy of catheter and surgical ablation procedures allowing improved management of these post-surgical patients.

The first iteration of the device was given FDA clearance back in 2002. The company said that the system hasn't received CE-mark approval.

The two studies are Cryo-Maze for Concomitant Atrial Fibrillation: Mid-Term Results using CardioNet Home Monitoring Testing by Evelio Rodriguez, MD, of the division of cardiothoracic and vascular surgery at the Brody School of Medicine, East Carolina University (Greenville, North Carolina), and "Atrial Fibrillation Detected by Mobile Cardiac Outpatient Telemetry in Cryptogenic TIA or Stroke," by A.H. Tayal, MD, of the Comprehensive Stroke Center at Allegheny General Hospital (Pittsburgh).

"There have now been 19 publications or abstracts related to the system," Aaron Goldmuntz, director of business development at CardioNet, told Cardiovascular Devices & Drugs. "This is just further validation of the clinical utility of this technology."

The study first utilized the CardioNet System for home monitoring of patients that underwent concomitant AF ablation to determine the efficacy of the procedure. The authors of the study noted that rhythm assessment after ablation with electrocardiogram (ECG) and/or Holter monitors has been shown to overestimate success, which led to their selection of the CardioNet System for the study. The study concluded that home monitoring with the CardioNet System should become standard of care after interventions performed to restore sinus rhythm in patients with AF.

The second demonstrates the feasibility of detecting AF in patients with stroke of undetermined etiology through prolonged monitoring. The study concluded that the CardioNet System detected a high rate of AF (23%) in patients that have experienced a transient ischemic attack or stroke for which the etiology was indeterminable through standard diagnostic evaluation methods.

Tayal, senior author of the study, commented: "Our study showed that mobile cardiac outpatient telemetry had a high rate of AF detection, including asymptomatic and short events, which may be a biomarker of prolonged and clinically significant AF. Such patients may benefit from anticoagulation and may not have been diagnosed with AF through standard methods."

Two additional studies utilized the CardioNet System for post-operative management and follow-up of patients that underwent surgical procedures to treat AF:

"Toward a Definitive, Totally Thoracoscopic Procedure for Atrial Fibrillation" – authored by John Sirak, MD, of the department of surgery in the Division of Cardiothoracic Surgery at Ohio State University (Columbus), and published in the Dec. 8, 2008, issue of The Annals of Thoracic Surgery.

"Surgical Correction Of Atrial Fibrillation With The Cryomaze Procedure: Long-term Outcomes Assessed With Continuous Outpatient Telemetry" – abstract presented by James Gammie, MD, University of Maryland Medical Center (Baltimore), at the Southern Thoracic Surgical Association's (Chicago) 55th annual meeting in November.

With nearly 20 published clinical papers and abstracts on the capabilities and efficacy of the CardioNet System, the company said it feels as if the system has been given a push in the right direction. One of the most important studies by far demonstrated the CardioNet System to be nearly three times superior in diagnosing clinically significant arrhythmias as compared to loop event monitoring, according to the company.

CardioNet says it provides ambulatory, continuous, real-time outpatient management solutions for monitoring relevant and timely clinical information regarding an individual's health.

Elsewhere in the product pipeline:

Abbott (Abbott Park, Illinois) is seeking to fill the treatment gap for treating coronary artery disease in narrower vessels, which accounts for about 10% of all procedures to treat lesions, with the start of a trial evaluating a 2.25 mm size of the company's Xience V everolimus eluting coronary stent system. "There are critical aspects in the design of this new Xience platform that represent improvements compared to larger stents," said Marco Costa, MD, PhD, director of the Center for Research and Innovation of Harrington-McLaughlin Heart and Vascular Institute, University Hospitals, Case Western Reserve University (Cleveland), and principal investigator of this new trial. "The first factor is the thickness of the struts," he said. "It's thinner compared to previous generations. That might translate into a better, more flexible device which is what we've seen in clinical practice. The amount of drug used is less, yet achieving similar or better outcomes. Our ability to treat is enhanced. That's the reason we're embarking on trying to reach small vessel sizes. Until recently we couldn't." Abbott won FDA approval of the Xience V stent for the treatment of coronary artery disease last July.

• Less than two months after FDA approval of Boston Scientific's (Natick, Massachusetts) Carotid Wallstent Monorail Endoprosthesis for patients with carotid artery disease who are at high risk for surgery, the first patient was enrolled in a 1,000-patient surveillance registry in December. Wallstent has the smallest free-cell area with a closed-cell stent design, according to the company. It has an ability to be re-constrained, allowing physicians to stop, re-constrain and re-deploy when necessary to get better placement. Scott Warren, group marketing manager, carotid solutions at Boston Scientific, said it is the only carotid artery stent system approved in the U.S. with an indication for bilateral carotid artery disease, meaning blockages in the carotid arteries on both sides of the neck. The stent is approved to be used along with the company's FilterWire EZ Embolic Protection System. The CABANA Study is a multi-center, U.S. surveillance registry designed to enroll a minimum of 1,000 patients at up to 150 sites.

Cheetah Medical (Portland, Oregon) reported FDA clearance for the NIBP functionality, provided by SunTech Medical (Morrisville, North Carolina), in its NICOM Reliant hemodynamic monitoring system. The NIBP option for the NICOM system platform and other feature enhancements add new parameters to provide a comprehensive suite of information for functional cardiac and systemic vascular monitoring - all without the need for invasive cardiovascular monitoring methods that are associated with increased potential costs and patient risks. The new parameters include noninvasive blood pressure, total peripheral resistance, stroke volume variation, cardiac power, and change in thoracic fluid content.

Epix Pharmaceuticals (Lexington, Massachusetts) reported FDA approval of Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels. Although MRA can be performed without the use of a contrast imaging agent, the company said Vasovist administration provides a clearer image in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs. The MRA is performed using MRI, which relies on magnetic fields to create highly detailed images of the inside the body. The active substance in Vasovist is gadolinium, a rare earth metal element that is detected by MRI scanners. When injected, gadoliunium interacts with water molecules in the body, giving a stronger signal and, in turn, a better picture. Vasovist now is approved for sale in 35countries.

Hiemstra Product Development (San Francisco) reported the introduction of hiQual, its electronic quality management system (eQMS). hiQual is Hiemstra's secure, web-based quality management system that is accessible to clients 24/7. The company says that the benefits of hiQual include increased productivity and improved communication by providing engineers immediate access to highly organized project documentation. A robust reporting engine monitors all business processes behind the scenes and provides statistical analysis for V&V. "With hiQual, Hiemstra now offers our clients a complete documentation package beginning with design and development through V&V and manufacturing," said Doug Hiemstra, president of the company.

King Pharmaceuticals (Bristol, Tennessee) said it has submitted a New Drug Application for CorVue (binodenoson) for injection to the FDA. CorVue is a cardiac pharmacologic stress SPECT (single-photon-emission computed tomographic) imaging agent intended for use in patients with or at risk for coronary artery disease (CAD) who are unable to perform a cardiac exercise stress test. In the NDA, King is requesting FDA approval of CorVue as an adjunct to non-invasive myocardial perfusion imaging (MPI) tests to detect perfusion abnormalities in patients with known or suspected CAD. The NDA includes two Phase III clinical studies that compared CorVue, a coronary vasodilator that is a selective agonist at the adenosine A2A receptor subtype, to adenosine, a current agent of choice for pharmacologic stress testing. The studies showed that CorVue achieved the primary endpoints for efficacy and tolerability, and has an improved side effect profile compared to adenosine. CorVue is being developed as an alternative to exercise prior to cardiac perfusion imaging for the diagnosis of coronary artery disease. It is designed to minimize side effects such as dyspnea, flushing, heart block, and chest pain.

Medistem (Chandler, Arizona) reported filing an Investigational New Drug application with the FDA to undertake clinical studies using its proprietary endometrial regenerative cells (ERC) in patients with critical limb ischemia. The IND application seeks permission from the FDA to administer ERC to 10 patients having specific inclusion/exclusion criteria and will focus primarily on gathering safety information; however, markers of efficacy will also be evaluated. The principal investigator of the proposed clinical trial is Michael Murphy, MD, of Indiana University School of Medicine (Indianapolis).

Medtronic (Minneapolis) reported the first enrollment in the company's FDA-approved clinical trial of its self-expanding (SE) Complete SE stent for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA). "Medtronic's clinical research program for peripheral arterial disease demonstrates a strong commitment to helping physicians and their patients," said the study's principal investigator, John Laird, MD, of the Vascular Center at the University of California, Davis. "Through three clinical trials currently underway, Medtronic is partnering with physicians worldwide to evaluate the safety and efficacy of its stents in the treatment of PAD." PAD patients have a two- to six-fold increase in cardiovascular mortality and a significantly increased risk of amputation, disability and diminished quality of life, the PAD Coalition reports. Approved by the FDA under an IDE, the SFA study is a prospective, multicenter, single-arm trial planned to enroll 178 subjects at up to 30 sites globally. Enrolling patients with symptomatic PAD in the SFA, the study has primary endpoints of major adverse events and patency of the stent at 12 months.

MiCardia (Irvine, California) reported the implant of its new Dynaplasty mitral valve repair device in two patients. The surgery marks the commencement of the company's study designed to provide data for CE mark of the Dynaplasty technology. Jochen Cremer MD, PhD, who led the cardiac surgery team for the implantation, said, "This is a new generation of dynamic repair device. It implanted easily using a conventional approach and the patients are doing well. We are excited to be participating in the DYANA study and believe Dynaplasty technology will address a major weakness of current devices, namely their inability to deal with changes in valve shape and function after the initial repair procedure."

OptumHealth (Golden Valley, Minnesota) said that it is providing a free personal health record (PHR) that is portable and can be shared with physicians, family member or others. The PHR is available through the web site www.myOptumHealth.com. Individuals can now transfer their PHR information from an OptumHealth-managed health portal directly into a Microsoft HealthVault account, which is a security-enhanced, Web-based consumer health platform. Information stored in HealthVault will be "portable" in that it will be available to members even if they change jobs or health plans. OptumHealth manages for employers and health plans, including UnitedHealthcare's myUHC.com. It enables individuals to store, maintain and retrieve their comprehensive health history in a secure and central location. With the ability to now transfer such information to Microsoft HealthVault, a broad range of health and wellness information such as physician visits, diagnostics and treatments will be pre-populated and combined with the member-generated information into one online location. Individuals transferring information into a HealthVault account can then share it, as desired.

Spectranetics (Colorado Springs, Colorado) reported FDA clearance for the Cross-Pilot laser support catheter. The Cross-Pilot is a laser support catheter for the 0.9 Turbo Elite Laser Ablation Catheter. The Cross-Pilot was designed to provide additional support for reaching distal lesions. The braid reinforced catheter construction and hydrophilic coating allow for better pushability through distal vessels and the angled tip allows for quicker access to branched anatomy. The Cross-Pilot Laser Support Catheter is currently offered in 125 cm length and straight and angled-tip configurations.

St. Jude Medical (St. Paul, Minnesota) reported the publication of a study on the St. Jude Medical Biocor Stented Tissue Valve – the second study published in recent months to report 20-year data showing excellent long-term durability of the Biocor tissue valve. Published in the January 2009 issue of the Journal of Thoracic & Cardiovascular Surgery, this prospective study compiles data from 1,712 patients, and is one of the largest published studies of tissue valves.

Visage Imaging (Carlsbad, California) said it has received FDA clearance to market its latest thin client product release, Visage CS 3.1. Visage says that this release brings significant enhancements to its prior offerings in cardiac and other tools, and includes new optional neuroradiology and oncology applications. The neuro option facilitates brain perfusion analysis in CT and MRI imaging, while the oncology option provides tools for analyzing, documenting, and comparing lesions for multiple modalities, including Standardized Update Value (SUV)- based analysis for PET-CT. In addition to the new application options, Visage CS 3.1 features numerous new and streamlined measurement and post processing tools such as advanced 3D segmentation, ROI-based analysis and time-value curves, and improved editing of cardiac LV models.

W.L. Gore & Associates (Flagstaff, Arizona) said that Peter Soukas, MD, interventional cardiologist from Caritas St. Elizabeth's Medical Center (Boston), enrolled the first patient in the Gore EMBOLDEN Clinical Study on Jan. 6. The first patient was recently symptomatic and over 90 years of age. The greater than 95% stenosis in the internal carotid artery was successfully stented under protection by the Gore Embolic Filter. Soukas said, "In spite of the near-total occlusion, the Gore Embolic Filter crossed easily and provided a stable platform for the remainder of the procedure. Moreover, the filter captured an impressive amount of embolic debris. One particularly large particle of plaque that was retrieved by the device would likely have put the patient at risk for a symptomatic event." The Gore Embolic Filter uses a diamond frame.

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