Reflecting the company's new emphasis on the interventional sector, Abbott Laboratories' (Abbott Park, Illinois) last month reported two major forward steps in the product development program of its Abbott Vascular (Redwood City, California) unit. In early April, Abbott Vascular reported that the first patient in the U.S. to be enrolled in its landmark clinical trial to assess the benefits of using stents in the neck arteries of likely stroke patients who have not shown symptoms of the disease was treated at the Hoag Heart and Vascular Institute at Hoag Memorial Hospital Presbyterian (Newport Beach, California).
The ACT I study, also known as the Carotid Angioplasty and Stenting vs. Endarterectomy in Asymptomatic Patients with Significant Extracranial Carotid Occlusive Disease Trial, is the first trial to study the potential benefits of minimally invasive carotid stenting in patients who normally would undergo a carotid endarterectomy (CEA) to prevent stroke. CEA is the current "gold standard" of treatment in asymptomatic patients, along with medication and lifestyle modification.
Stroke represents the third-leading cause of death and the No. 1 cause of disability in the U.S. with more than 700,000 Americans suffering strokes each year. Nearly 90% of all strokes stem from insufficient blood supply to the brain, a condition caused by narrowing or blockage of embolic blood vessels.
ACT I is a multi-center, randomized study to compare carotid artery stenting to carotid artery surgery in asymptomatic patients i.e., those who have not displayed symptoms of stroke, but who are at risk who normally would be referred for surgery.
"This important clinical trial challenges the final frontier in carotid therapy by comparing carotid stenting with standard CEA in asymptomatic patients," said Subbarao Myla, MD, medical director of cardiovascular research at the Hoag Heart and Vascular Institute and the principal investigator for the ACT I study. "This has enormous importance since approximately 75% of carotid surgery in the country is done on such patients," he added.
The FDA recently approved carotid artery stenting for patients who require immediate intervention to prevent stroke, but it is limited to those who have medical conditions that deem them too high-risk for surgery (i.e., previous stroke or transient ischemic attack, congestive heart failure, unstable angina and severe lung disease).
Abbott Vascular also reported last month that it had submitted a premarket approval (PMA) application to the FDA for its StarClose Vascular Closure System, what it termed a "next-generation" vessel closure system specifically designed for the mechanical closure of femoral arteries following catheterization procedures, such as angioplasty and stent placement.
The StarClose is designed to quickly and securely deliver a flexible nitinol clip to mechanically appose or bind the surface of a femoral artery together following a catheterization procedure. StarClose received CE certification in February 2004, and was officially launched outside of the U.S. last year.
Tony Chou, MD, an interventional cardiologist and general manager of vessel closure technologies at Abbott Vascular, said that if approved, the StarClose represents the next revolution in the company's vascular closure offerings. "Our analysis has shown that StarClose is a device that was as safe as manual compression with an extra vascular approach and a design that could potentially minimize the risks associated with other methods of femoral artery closure."
Integrated Vascular Systems (IVS; Sunnyvale, California) originally developed the StarClose clip technology and Abbott acquired IVS in September 2003. Chou noted that the company already sells the Perclose suture-mediated closure system, which it acquired with its 1999 acquisition of Perclose (also Redwood City). Another product in the company's vascular closure portfolio is the Chito-Seal topical hemostasis pad, which expedites clot formation and accelerates hemostasis. That product was launched in 2002.
Elsewhere in the product pipeline:
ACI Medical (San Marcos, California), a biomedical engineering firm developing technologies to treat vascular conditions, reported positive results from a new, independent study that found its ArtAssist device to be an effective method for improving the long-term walking capacity and quality of life for patients with walking impairment due to arterial disease. Published in the March issue of Annals of Surgery, the study examined 41 patients who had been diagnosed with leg pain caused by poor circulation, a condition known as intermittent claudication. An experimental group was given the ArtAssist, ACI Medical's in-home device that increases arterial blood flow through compression cuffs covering the foot, calf and ankle. The patients used the device daily for five months. They also were given aspirin and asked to exercise unsupervised. A control group only received aspirin and exercised unsupervised. The study's authors determined that intermittent pneumatic compression therapy to the foot and calf through the ArtAssist device significantly improved the walking ability of patients. Their pain-free walking distance increased by a median of 197%. Results from the study also found the group using the ArtAssist device benefited from a better quality of life than the control group as measured by their physical functioning, bodily pain, vitality, social functioning, and the perception of general and mental health.
Alliance Medical (Phoenix), a reprocessor of single-use medical devices, reported the FDA has cleared the final two 510(k)s filed by the company in response to the agency's supplemental validation submission request. The two clearances cover reprocessed electrophysiology (EP) catheters by Daig and EP Technologies. The company said the FDA's decision to grant Alliance the 510(k) clearance illustrates the company's compliance with the Medical Device User Fee and Modernization Act of 2002. Once reprocessed, the diagnostic EP catheters are intended to be used for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
AngioScore (Alameda, California), a developer of angioplasty tools for interventional cardiologists and radiologists, reported the completion of the U.S. clinical trial for its flagship AngioSculpt Scoring Balloon Catheter in coronary lesions and the conclusion of follow-up on the 200 patients in the trial. The multi-center clinical trial is a prospective clinical study of the safety and efficacy of the AngioSculpt scoring balloon catheter in 200 patients undergoing angioplasty to treat coronary artery disease. The study examines acute outcomes when the AngioSculpt scoring balloon catheter is used for the treatment of a hemodynamically significant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion. Principal Investigator Martin Leon, MD, associate director of Cardiovascular Interventional Therapy at Columbia University Medical Center and chairman of the Cardiology Research Foundation (both New York), said, "The AngioSculpt Scoring Balloon Catheter is a promising new approach to dilatation of challenging lesions and potentially a valuable adjunct to drug-eluting stents, facilitating precise stent placement and complete expansion."
AnorMED (Vancouver, British Columbia) said it has filed an investigational new drug application with the FDA for approval to begin its clinical program for AMD3100 in cardiac patients. The filing is the first step in evaluating the potential of AMD3100, a stem cell mobilizer, to help repair damaged heart tissue in patients who have suffered heart attacks. "We are excited about the possibility that our lead drug candidate, AMD3100, may have additional therapeutic applications beyond the ongoing Phase III study for stem cell transplant in cancer patients," said Dr. Michael Abrams, CEO and president.
Biopure (Cambridge, Massachusetts) reported completing enrollment in the Phase II human clinical trial in Europe evaluating the safety and feasibility of its investigational oxygen therapeutic Hemopure [hemoglobin glutamer - 250 (bovine)] in patients undergoing elective coronary angioplasty. Generation of trial data, it said, will conclude at the end of April after all enrolled patients complete a 30-day follow-up period. Biopure said it is hopeful that the clinical trial investigators will be able to present preliminary results in May at the late-breaking session of the EuroPCR conference in Paris. The clinical trial was designed as a randomized, double-blind, dose-finding, multi-center study to assess the safety and feasibility of Hemopure in patients with coronary artery disease. In related preclinical research published in the April issue of the American Journal of Physiology - Heart and Circulatory Physiology, researchers at Louisiana State University (New Orleans) reported the results of an animal study of Hemopure.
Cambridge Heart (Bedford, Massachusetts) reported that it has received FDA clearance to begin marketing in the U.S. of its new Heartwave II System for the measurement of Microvolt T-Wave Alternans (MTWA), and that the product is now available. The Heartwave II System is a stand-alone device to measure MTWA to help predict an individual's risk of sudden cardiac death. Unlike the original Heartwave System, the Heartwave II does not require a host stress exercise system to control the treadmill or to monitor the patient's ECG (electrocardiogram) or electrical activity of the heart. Running on a Microsoft Windows XP operating system, the look and feel of the Heartwave II is more familiar for the user, the company said. The Pentium processor included in the Heartwave II can process information up to 15 times faster than the original Heartwave, and its increased memory capacity can store 300 times more patient studies.
CHF Solutions (Brooklyn Park, Minnesota) reported the launch of the Aquadex FlexFlow System, its next-generation technology used to treat fluid overload in patients with renal failure, post-surgical fluid overload, metabolic disease or congestive heart failure. The new system offers greater flexibility and precision in setting blood-flow and fluid-removal rates, the company said. It introduced the Aquadex FlexFlow at the annual conference of the International Society for Heart and Lung Transplantation (Addison, Texas) in Philadelphia earlier this year. The Aquadex FlexFlow is used to perform Aquapheresis, a procedure to safely and predictably remove excess salt and water from fluid-overloaded patients. With the system, physicians have more choices in venous access sites and expanded catheter capability, CHF said.
Corautus Genetics (Atlanta) reported that as the result of its scheduled interim safety analysis, the independent data monitoring committee (DMC) recommended the continuation of GENASIS (Genetic Angiogenic Stimulation Investigational Study), Corautus' Phase IIb clinical trial to evaluate the safety and efficacy of Vascular Endothelial Growth Factor-2 (VEGF-2) for the treatment of patients with severe angina. The planned interim safety analysis was conducted after the first 54 patients were treated in the trial. Based upon their review of the available data, the DMC recommended continuing the GENASIS trial. GENASIS is a randomized, double-blinded, dose-ranging and placebo- controlled Phase IIb multi-center clinical trial, which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. In the GENASIS trial, defined doses of VEGF-2 in the form of "naked" plasmid DNA, a non-viral delivery vector, are delivered to diseased heart muscle tissue via the Boston Scientific (Natick, Massachusetts) Stiletto endocardial direct injection catheter system.
Corgentech (South San Francisco, California) and Bristol-Myers Squibb (Princeton, New Jersey) reported top-line results from PREVENT IV, a Phase III clinical trial evaluating the use of edifoligide (E2F Decoy) to prevent vein graft failure following coronary artery bypass graft surgery. The companies said treatment with Corgentech's E2F Decoy failed to meet the trial's primary and secondary endpoints. E2F Decoy was generally well tolerated in the 3,014-patient trial. The complete data from the PREVENT IV trial will be presented in future publications and presentations by the study's clinical investigators. Bristol-Myers Squibb said it has advised Corgentech that it will be terminating the collaboration on the E2F Decoy, consistent with the terms of their agreement.
Criticare Systems (Milwaukee) reported introduction of the Veris MRI monitoring system, a joint development effort with Medrad (Indianola, Pennsylvania). This program began in 2003 as a multi-year agreement with the goal of developing an advanced monitoring system specific to MRI applications. Veris is the first MR monitor with five-lead ECG waveform monitoring and is compatible with 3T MRI environments. The system brings an array of features and accessories, including those designed for pediatric and neonate patients, to MRI environments of up to 3T. Veris can also be equipped with gas technology through the integration of the Criticare respiratory analyzer. It is available in six configurations to meet specific customer needs for anesthesia, sedation, cardiac MR, research and basic patient monitoring.
Enpath Medical (Minneapolis) reported that it has received CE approval from the European Union to begin marketing its steroid epicardial lead in Europe for one of its two contract customers for this product. It said it expects sales to the European market to commence immediately. The company anticipates CE approval on a second version of the steroid epicardial lead for its other contract customer in the next several weeks. Enpath also reported that the FDA has indicated it will require prospective human clinical data prior to approving the company's submission of its steroid epicardial lead.
EPIX Pharmaceuticals (Cambridge, Massachusetts) reported initiation of a Phase II proof-of-concept trial for EP-2104R, its injectable MRI agent designed to detect blood clots throughout the body. In a Phase I trial, completed late last year, EP-2104R was well-tolerated by healthy subjects at all doses. The Phase II proof-of-concept program is being conducted at multiple sites worldwide to further test safety and test preliminary efficacy of EP-2104R for the evaluation of blood clots in patients presenting with strong suspicion of clots from thrombo-embolic disease. EP-2104R-enhanced MR imaging will be compared to other diagnostic imaging tests to determine the location and size of blood clots. About 40 patients are expected to be enrolled in the trial. EPIX is collaborating with Schering (Berlin) in the development of EP-2104R.
ImaRx Therapeutics (Tucson, Arizona) said the first patient has been treated in a new Phase II clinical trial evaluating the safety and effectiveness of SonoLysis for the treatment of acute ischemic stroke. SonoLysis, which combines external ultrasound and ImaRx's nanobubble, is designed to clear blood clots quickly and without the use of invasive surgery or potentially dangerous lytic drugs. "Our SonoLysis nanobubbles are injected intravenously to accumulate at the site of a blood clot. With the application of ultrasound, the bubbles are designed to pulsate and break apart to physically impact and destroy the clot," said Evan Unger, MD, president and CEO of ImaRx. "SonoLysis has the potential to clear clots more quickly than the current standard of care, which is important because faster treatment can help minimize the neurological damage and disability caused by strokes." ImaRx's multi-center trial is a 40-patient, randomized and blinded study.
Kensey Nash (Exton, Pennsylvania) has begun enrollment in the ASPIRE (for Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) study for its new TriActiv FX System. ASPIRE is a multi-center, prospective registry, designed to support regulatory clearance of the TriActiv FX System in the U.S. for a saphenous vein graft (SVG) indication. The company recently reported receipt of FDA and CE mark approval for its FX System. Kensey Nash said the system incorporates several ease-of-use design enhancements to the TriActiv System platform, including a new balloon inflator that simplifies catheter exchanges during the procedure, and a monorail flush catheter to enhance device usage and reduce procedure time. About 20 centers will participate in the study, which will enroll 100 patients.
Medtronic (Minneapolis) reported the recent introduction of the Attain Select 6238 TEL Guide Catheter Set that aids in the safe and effective implantation of device leads in the veins that serve the left side of the heart for the treatment of heart failure. The Attain Select products, now available in the U.S., Europe and Canada, are highly specialized to give physicians a range of choices as they work from outside the body to select the most appropriate cardiac veins leading to the heart's lower left chamber and safely maneuver an insulated lead through them to carry electrical impulses from an implanted cardiac resynchronization therapy device. The set includes catheters in three shapes: one shaped with its tip in a 90-degree curve and another with a 180-degree curve; and a straight catheter to aid in cannulation of the coronary sinus or in crossing partially blocked or narrowed veins. The catheters of the new set offer stiffness, the ability to deliver contrast media, and clear fluoroscopic trackability. Their softer tips are designed to reduce risk of trauma to blood vessels and their smaller inner lumens (0.040" diameter) provide precise tracking over any guidewire with up to a 0.035" diameter. The Attain Select catheters are designed to fit inside current Medtronic Attain catheters that are used for coronary sinus cannulation.
Medtronic Vascular (Santa Rosa, California) said that it has obtained CE mark approval on its Valiant Thoracic Stent Graft with Xcelerant Delivery System for commercial release in Europe. Valiant is a robust, next-generation stent graft built on the company's thoracic endovascular clinical history, which includes more than 16,000 implanted grafts. The Valiant system is more conformable than earlier-generation devices and the new delivery system enables precise transluminal deployment of the stent graft. It also offers more size and end configuration options. The Valiant thoracic system also will offer covered graft lengths of up to 20 centimeters for maximum lesion coverage and the use of fewer graft segments to complete procedures. The company said its commercialization of the Valiant system outside the U.S. would be phased in over the spring and summer.
Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said that it has submitted to the FDA an amendment to its corporate investigational new drug (IND) application for Lymphoseek. The amendment submission included updated results from clinical and preclinical evaluations completed to date with Lymphoseek. In addition, Neoprobe's submission included a complete draft of a proposed multi-center clinical evaluation of Lymphoseek and the Investigator's Brochure for the conduct of the study. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in a variety of tumor types. In connection with the establishment of the corporate IND for Lymphoseek, the FDA provided guidance that it would prefer to have Lymphoseek evaluated in a multi-center clinical study to confirm the findings observed by the University of California, San Diego researchers. The initial multi-center trial would then be followed by a confirmatory Phase III study using the final cGMP material. Neoprobe said it intends to begin enrollment in the first of the two multi-institutional studies as soon as the appropriate regulatory and institutional review board clearances are received.
St. Jude Medical (St. Paul, Minnesota) reported that it has received FDA approval to activate V-V (ventricle to ventricle) timing in all models of its Epic HF and Atlas+ HF CRT-Ds (cardiac resynchronization therapy defibrillators). St. Jude said it is the only company with FDA approval for V-V timing in CRT defibrillators. Patients implanted with these devices now have the therapeutic option of V-V timing programmability, which is designed to optimize the benefits of resynchronization pacing. This upgrade is made possible by a programmer software enhancement, and can be enabled during a patient's regular visit with a clinician. The feature had previously been available only in certain models of the St. Jude Medical Epic HF and Atlas+ HF CRT-Ds. The V-V timing feature allows physicians to adjust the delay between ventricular outputs, as well as choose which chamber is paced first. Patients who do not respond to simultaneous pacing may benefit from the sequential timing offered by V-V programmability.
Toshiba America Medical Systems (Tustin, California) said clinical researchers at Beth Israel Deaconess Medical Center (BIDMC; Boston) reported the completion of the first chest pain evaluation using electrocardiogram-gated (ECG-gated) imaging performed with the Toshiba Aquilion 64. Featuring advanced multi-detector computed tomography (CT) technologies, the Aquilion 64-detector CT uses Toshiba's 64-row Quantum detector, which enables the Aquilion CT scanner to acquire 64 simultaneous slices of 0.5 mm for precise volumetric imaging of any region of the body during a breath-hold under 10 seconds. At BIDMC, a patient with chest pains and significant shortness of breath during exertion was scanned with the recently installed Aquilion 64 to determine if the symptoms were related to a problem with the lungs or the heart. "We are just beginning to realize the full potential of using the Aquilion 64-slice CT, and we fully expect a leap in image quality from the previous 16- and 32-slice CT technology," said Melvin Clouse, MD, professor of radiology and director of research at BIDMC. Clouse recently discussed the results of the latest clinical studies performed with the Aquilion 64 at Snowmass 2005: Imaging with CR and MR meeting in Colorado in February.
Tensys Medical (San Diego), a leader in real-time blood pressure management, reported the introduction of the TL-150, a continuous, non-invasive blood pressure monitoring system with accuracy clinically proven equivalent to an arterial line. The company said the TL-150 introduces significant technological advancements over the original T-Line system, including improvements such as reduced set-up time and improved motion tolerance. The non-invasive, beat-to-beat capability of the new TL-150 enables continuous monitoring of even the most difficult surgical patients and provides the confidence of real-time feedback on the impact of interventions for optimal blood pressure management, Tensys said.
Thoratec (Pleasanton, California) reported that the first patients have been enrolled in the destination therapy and bridge-to-transplantation (BTT) arms of the Phase II pivotal trial for its HeartMate II LVAS (left ventricular assist system) device. This is in addition to the 25 BTT patients that were enrolled in the Phase I trial. Thoratec said that several of the participating centers have received institutional review board approval to participate in the study. The HeartMate II is a next-generation heart-assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure. Separately, Thoratec reported that a Chicago man is the first in the nation to receive the HeartMate II Left Ventricular Assist (LVAS) device in a destination therapy clinical trial. The procedure was performed by Mark Slaughter, MD, director of the mechanical assist device program at Advocate Christ Medical Center (Oak Lawn, Illinois). The HeartMate II is an implantable, continuous-flow device designed to provide long-term cardiac support for patients who are in late-stage heart failure. The national pivotal trial will determine the safety and efficacy of the device as DT in late-stage heart failure patients and will involve 200 total patients at up to 40 sites, randomizing the HeartMate II to the HeartMate XVE LVAS. Thoratec's HeartMate XVE is the only commercially available LVAS FDA-approved for DT. In a separate arm of the study, the HeartMate II will be evaluated as a bridge-to-transplant (BTT) for late-stage heart failure patients who are eligible for cardiac transplantation but in need of temporary support until a donor heart becomes available. Up to 25 sites will enroll a total of 133 patients in the BTT arm.
Toshiba Medical Systems (Tokyo) reported the beginning of patient evaluations in what it said is the industry's first multi-center clinical study on coronary computed tomography angiography (CTA) imaging using 64-slice CT technology. Initial results of the study will be released in 2006. In November 2004, Toshiba launched CorE 64 (Coronary Evaluation on 64), an international collaboration with its partners to investigate the use of multislice CT as the primary diagnostic tool for detecting cardiovascular diseases and disorders, as compared to cardiac catheterization. The patient evaluations will involve non-invasive diagnostic imaging of cardiac patients using Toshiba's CT technologies, such as the Aquilion CFX 64-slice CT, 64-row Quantum Detector and SURECardio and SUREPlaque applications for a period of several months, as well as regular meetings with the study group to measure and discuss the clinical effectiveness of cardiac CT imaging against cardiac catheterizations. Separately, Toshiba America Medical Systems (Tustin, California) said clinical researchers at Beth Israel Deaconess Medical Center (BIDMC; Boston) reported the completion of the first chest pain evaluation using electrocardiogram-gated (ECG-gated) imaging performed with the Toshiba Aquilion 64.