The number of patients who could benefit from cardiac resynchronization therapy (CRT) with and without defibrillator backup could dramatically increase if results of a new worldwide clinical trial sponsored by Medtronic (Minneapolis, Minnesota) are positive. The REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) trial is being undertaken to determine whether CRT can help limit the downward spiral of heart failure in people who currently have mild or even no symptoms but poor heart pumping function. Previous studies have shown that CRT reduces symptoms and improve exercise capacity in people with more advanced forms of heart failure.
CRT is currently indicated for patients with moderate-to-severe heart failure. The REVERSE trial will evaluate patients who have mild symptoms, or who were previously symptomatic but currently are without symptoms. All will have poor heart pumping function, ventricular dysynchrony and meet other criteria. Approximately 60% of patients with heart failure have mild or no symptoms. However, even with current conventional treatment, death or progression to a more symptomatic class is almost certain for these patients.
"Right now, CRT is only indicated for the more advanced forms – Class III and IV patients New York Heart Association [NYHA]," Scott Papillon, senior public relations manager for Medtronic, told Cardiovascular Device Update. "This is going to be looking at the [NYHA] ones and twos to see if they can benefit from it." He noted that the 2,521-patient Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which was sponsored by Medtronic and the National Institutes of Health (Bethesda, Maryland), showed that the use of a defibrillator appeared to benefit Class II heart failure patients even more than Class III patients. While he noted that the study didn't look at CRT per se, it was an encouraging development whose results could translate to CRT.
"Many people have had their lives transformed by CRT and now have new hope for a better life," said Cecilia Linde, MD, associate professor at the Karolinska Institute (Stockholm, Sweden), the world-wide principal investigator of the REVERSE trial. "Not only will this trial attempt to determine if a larger class of patients might benefit from cardiac resynchronization, but it will shed light on the cost-effectiveness of this therapy. This should help healthcare systems make the best possible use of their resources."
Heart failure is responsible for 1 million hospitalizations a year in the U.S. alone, more than all forms of cancer combined, and a similar number in Europe. It affects roughly 22 million people worldwide. Cardiac resynchronization therapy helps resynchronize the beating of the heart, often with dramatic quality of life improvements for many heart failure patients.
Trial investigators will implant Medtronic's InSync family CRT pacemakers or CRT defibrillators in more than 500 patients at approximately 100 centers in Europe, the U.S. and Canada. Physicians will select the appropriate device to be implanted based on the patient's specific indication. On a randomized basis, two-thirds of the participants will have CRT turned on, and the other one-third will have CRT turned off to serve as a control group. All patients in the study will receive optimal drug therapy and will be followed for at least a year. At the end of the follow-up period, patients in the control group will begin receiving CRT therapy. All patients involved in the trial have a broad range of underlying causes for their heart failure, including those with and without a previous heart attack or coronary heart disease.
Papillon said the trial is similar to Guidant's (Indianapolis, Indiana) ongoing MADIT-CRT trial, which also is designed to test whether CRT devices with defibrillator backup will slow the progression of heart failure in patients with impaired heart function and little or no symptoms. However, he said Medtronic's trial has a broader patient population because it includes both ischemic and non-ischemic patients and said that the ejection fraction and QRS rates are different between the studies.
The primary endpoint of the study is a clinical composite score that measures key outcomes such as mortality, hospitalization for worsening heart failure, quality of life and symptoms. Secondary endpoints include changes in the size of enlarged hearts and costs to the healthcare system.
Elsewhere in the product pipeline:
AccessClosure (Mountain View, California) reported completion of enrollment in the pivotal U.S. clinical investigation designed to evaluate the safety and efficacy of the Matrix VSG System, a synthetic wound-healing hydrogel designed to seal femoral artery punctures after interventional and diagnostic endovascular procedures. Between December 2003 and June, a total of 500 patients were randomized to either the Matrix VSG System or to standard compression at 13 medical centers. Another 127 patients were treated with Matrix VSG during the roll-in phase of the trial. The technology also has been used in Germany for sealing femoral artery puncture sites during two limited clinical investigations involving 112 patients. The Matrix VSG System involves the simultaneous injection of two synthetic fluid components into the tissue tract of the vascular access site. Once delivered, the fluids mix subcutaneously to form a hydrogel sealant over the arterial access site, around the artery and in the tissue tract. The fluids are comprised of fully synthetic and non-thrombogenic polyethylene glycol (PEG), a biomaterial commonly used in medical devices and pharmaceutical products. The PEG hydrogel is designed to be fully absorbable in the body in less than 30 days, leaving behind only a completely healed puncture site.
Biosite (San Diego, California) has devised a new point-of-care panel that will be used to aid in the diagnosis of patients who present at emergency departments with shortness of breath, with the company saying that more than 10 million people present at EDs each year with a combination of chest pain and shortness of breath, or dyspnea. Called the Triage Profiler Shortness of Breath panel, the new diagnostic symptom panel is intended to "accelerate and improve emergency department evaluation of shortness of breath," the company said. Gillian Wotherspoon, hospital segment manager at Biosite, said the company began working on the shortness-of-breath panel two to three years ago. "There exists a need within the marketplace to quickly differentiate causes of shortness of breath, because the underlying causes potentially can be so catastrophic. In many cases, shortness of breath presents in the elderly, who have co-morbidities and the diagnosis is very unclear." Toward the goal of getting a clearer picture, the Triage Profiler Shortness of Breath panel tests for levels of five biomarkers: B-type natriuretic peptide (BNP), D-dimer, myoglobin, CK-MB and cardiac troponin I. All five markers are cleared by the FDA based on clinical evidence, but it was Biosite's concept to package them together in one device. The test, which provides results in 15 minutes, aids in the diagnosis of myocardial infarction, the diagnosis and assessment of severity of congestive heart failure, the assessment and evaluation of suspected disseminated intravascular coagulation (including pulmonary embolism) and the risk stratification of patients with acute coronary syndromes.
Boston Scientific (Natick, Massachusetts) reported the worldwide launch of its Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch for vascular or cardiac patch grafting. The company said the Hemashield Platinum Finesse patch has 50% improved porosity over the existing Hemashield Finesse Patch and provides excellent hemostasis, or a reduced amount of bleeding after closing the incision. The patch is tapered and pre-trimmed for greater efficiency and conforms to the host vessel for improved handling. It features a thin profile with a high degree of suture strength for a smooth, secure closure with sutures that will remain intact, even at the edge of the patch, the company said.
Cardiac Science (Irvine, California) received FDA 510(k) clearance to market its new Powerheart G3-Automatic automated external defibrillator (AED), calling it "the first fully-automatic AED in the Powerheart product line." The new-generation AED has been designed for public places, corporate settings and in-home use. A rescuer need only listen to the Powerheart's voice instructions explaining how to attach the device to the heart attack victim. There are no buttons to push or additional action required. The Powerheart analyzes the patient's condition to detect a life-threatening heart rhythm and, when appropriate, delivers a defibrillation shock or shocks to restore the heart to normal rhythm. The company cited the features of "robust Rescue-Ready self-testing technology [and] advanced detection algorithms in a package that promises maintenance-free operation."
Cook (Bloomington, Indiana) reported receiving the first clearance in the U.S. to begin investigational use of a fenestrated endovascular graft for complex abdominal aortic aneurysms (AAAs). The FDA approved investigational use of its Zenith Fenestrated AAA Endovascular Graft to treat abdominal aortic or aortoiliac aneurysms. The fenestrated device is customized to meet the anatomic needs of each individual patient, incorporating scallops at the top and openings in the graft wall – called fenestrations – that allow it to be implanted precisely in the aorta across adjacent blood vessels without blocking blood flow through those vessels. The graft is fabricated from woven polyester vascular graft material hand-sewn to self-expanding Z-stent bodies. It is customized to meet each patient's aortic anatomy, which can be challenging due to tortuosity, length or size. Without this fenestrated graft, the company said, surgeons would have to put a fabric tube down through the aorta that would block the renal arteries and several other small blood vessels that come off of the aorta. The agency approved Cook's investigational device exemption application for clinical studies at five U.S. medical institutions involving 25 patients. The device is based on Cook's Zenith AAA endovascular graft design, a device that was cleared for sale in the U.S. in May of last year. The system is already approved for sale in Australia and is available as a custom device in Europe.
Corautus Genetics (Atlanta, Georgia) reported that the FDA has approved the start of its Phase IIB clinical trial for the treatment of severe cardiovascular disease. The trial will be a national, randomized, double-blinded, dose ranging and placebo controlled study of up to 404 patients in up to 20 centers in the U.S. evaluating the efficacy and safety of defined doses of Vascular Endothelial Growth Factor-2 (VEGF-2) to be percutaneously delivered via Boston Scientific's Stiletto endocardial direct injection catheter. The trial will enroll qualified patients with Class III or IV angina. Patient enrollment is expected to begin during the third quarter.
Creative Clinical Concepts (Denver, Colorado) said an aspirin resistance test from its AspirinWorks subsidiary is now available nationwide. The test, also known as AspirinWorks, is suited for patients on long-term aspirin therapy and can be ordered by any doctor's office or hospital laboratory in the U.S., the company said. The urine test measures an individual's response to aspirin dosage, allowing physicians to adjust the dosage or recommend alternative therapy. Creative Clinical Concepts said more than 20 million Americans take aspirin regularly to help prevent heart attacks and strokes, but up to 25% or more are resistant to aspirin or taking an inadequate dosage.
CryoCor (San Diego, California) has received conditional approval to begin a U.S. pivotal clinical study to treat paroxysmal atrial fibrillation under an investigational device exemption granted by the FDA. The purpose of the pivotal study is to evaluate the safety and efficacy of the CryoCor Cardiac Cryoablation System, a minimally invasive medical device that employs cryogenic energy and a single-use cardiac catheter. Investigators at up to 25 clinical sites in the U.S. will use CryoCor's system – intended to selectively freeze cardiac tissue to block conduction of the abnormal electrical signals causing atrial fibrillation and return the heart to its normal rhythm.
Devax (Irvine, California) reported the initiation of the Axxess Plus Clinical Study for the company's Axxess Drug-Coated Stent System. The Axxess system is the first bifurcated stent design to elute an anti-restenonic drug. The study is a multi-center trial to evaluate both the acute and long-term clinical utility of the Axxess Stent System for the treatment of bifurcated lesions in native coronary arteries. Within the past week, two patients were treated with the Axxess Stent System in two clinical centers in Germany. The system was successfully implanted in both patients with no acute complications. Devax said it expects to add up to 15 international centers in the study over the next few months and complete patient enrollment by the end of the year. All patients will receive six-month follow-up angiography to evaluate long-term outcomes.
Epix Medical (Cambridge, Massachusetts) reported initiation of its post-new drug application clinical program with the first injection in a multi-center trial of MS-325 for high-resolution vessel imaging. MS-325 is a magnetic resonance imaging blood pool contrast agent designed for vascular applications. The study's goal is to improve high-resolution imaging with MS-325 as the first step in the characterization of vascular wall structures and vulnerable plaque. The product has been co-developed by Epix and Schering AG (Berlin, Germany), with Epix saying MS-325 may be an alternative to invasive X-ray angiography for diagnostic vascular imaging.
GE Healthcare (Waukesha, Wisconsin) reported the commercial introduction of the LightSpeed VCT, or volume CT (computed tomography), which one product manager called "the beginning of the volume CT generation of CT scanners." The new device will be available later this year. "What we mean by [VCT] and what has actually been defined ... in the scientific literature, as far as volume and what volume CT means, is it is the combination of wide-volume coverage at thin slice, so the ability to do both simultaneously," said Scott Schubert, global product manager for the LightSpeed VCT. "That's always been the strength of CT, to be able to acquire thin slices, but now with the LightSpeed VCT system, we're able to acquire four times the volume coverage on the 64 channels compared to the coverage that was available on 16-slice scanners." He said that GE's product is the "world's only 64-channel CT system" that enables "breakthrough clinical applications, particularly in cardiovascular emergency room situations, trauma studies and neurovascular studies. [Those] are what we've heard from thought leaders are the significant breakthrough areas where volume CT makes a dramatic clinical difference."
The FDA has cleared for marketing Intuitive Surgical's (Sunnyvale, California) da Vinci surgical system to assist in coronary artery bypass surgery in which there is direct access to the chest using standard open chest technique (sternotomy) or a smaller surgical incision (thoracotomy). The device already is cleared for general laparoscopic gall bladder and reflux disease surgery, for general non-cardiac thoracoscopic chest surgery, and for thoracoscopically-assisted cardiotomy procedures (including, for example, mitral valve repair). This indication broadens the use of the system, allowing surgeons in the U.S. to perform coronary artery bypass graft (CABG) surgery with small incisions. Ben Gong, vice president of finance and treasurer for Intuitive, said that while the system already is being used for CABG procedures under the company's thoracoscopic approval, "surgeons in the U.S. will [now be able to] use this system to bring down the internal mammary arteries, and that's the first part of a CABG procedure." Prior to this approval, he said surgeons would make a small incision and then they would do the anastomosis on the heart with traditional hand-held instruments. Lonnie Smith, president and chief executive officer of Intuitive, said the approval allows U.S. surgeons to offer their patients "an attractive alternative to traditional cardiac surgery." Douglas Murphy, MD, chief of cardiac surgery at St. Joseph's Hospital (Atlanta, Georgia) and an investigator in the trial, said, "We can now perform robotic cardiac revascularization in its entirety, from internal mammary artery harvest to performing the critical anastomosis with unparalleled precision." The da Vinci system consists of a surgeon's viewing and control console having an integrated, high-performance InSite 3-D vision system, a patient-side cart consisting of three or four robotic arms that position and precisely maneuver endoscopic instruments and an endoscope, and a variety of articulating EndoWrist Instruments.
Lifestream Technologies (Post Falls, Idaho), a manufacturer of home cholesterol monitors and professional screening devices, said the results of an independent accuracy and precision study showed that the Lifestream Cholesterol Monitor's results proved as accurate as test results received from a physician's office. The study compared the Lifestream monitor against three professional methods: a physician's office lab system, a local independent lab, and the Abell-Kendall method, the U.S. government accuracy and precision standard for all cholesterol test devices. Christopher Maus, Lifestream's president and chief executive officer, said the study was motivated by recent articles which implied that results provided by home cholesterol test devices were inaccurate.
Medtronic (Minneapolis, Minnesota) reported FDA approval and the commercial release of the InSync Maximo cardiac resynchronization therapy defibrillator system. With 35 joules of delivered energy and the industry's fastest charge times, InSync Maximo provides the highest margin of safety in treating sudden cardiac arrest, the company said. Like most recent Medtronic implantable defibrillators, the InSync Maximo system offers anti-tachycardia pacing options for pain-free termination of life-threatening fast ventricular tachyarrhythmias. Medtronic also reported that it has received FDA approval to market the Sprinter Semi-Compliant Over-the-Wire Balloon Dilatation Catheter in the U.S. The Sprinter balloon is available in lengths of 6 mm, 12 mm, 15 mm, 20 mm, 25 mm and 30 mm and diameters ranging from 1.5 mm to 4.0 mm. A low-profile FasTrac tapered tip enables reaching and treating the most challenging lesions. The Sprinter balloon offers the lowest lesion-entry profile (0.016") in its class. The automated MiniWrap Folding Process provides for an extremely tight wrap of the balloon on the catheter and incorporates advanced rewrap properties for multiple inflations. The Sprinter Balloon is coated with Selective Dura-Trac Coating after it is folded, providing the performance of a fully coated balloon while tracking through tortuous vessels. The material inside the folds is uncoated, which provides traction upon expansion in the lesion.
Medtronic Vascular (Santa Rosa, California) received the CE mark for its Interceptor PLUS Carotid Filter System. The Interceptor PLUS system can be used in combination with the Exponent Carotid Stent from Medtronic or other approved carotid stents to reopen blockages of the carotid arteries and improve blood flow to the brain, while reducing the risk of stroke by capturing embolic materials that can be freed during a stenting procedure. The filter features a simplified, intuitive delivery system that does not require the use of a sheath for deployment. The filter system is offered in sizes to fit vessel diameters from 4.25 mm to 6.25 mm, with a lesion crossing profile of only 0.036". Its braided nitinol filter features excellent conformity to vessel walls.
MIV Therapeutics (Vancouver, British Columbia) reported completing the full range of biocompatibility studies on its biocompatible hydroxyapatite (HAp) ultra-thin coating technology. The coating is designated for passive and drug-eluting application on cardiovascular stents and other implantable medical devices. Toxikon (Bedford, Massachusetts) performed the complete range of 12 biocompatibility tests, the results of which included a test that found a Hap-coated stent to be non-toxic when implanted intramuscularly for 13 weeks.
Recom Managed Systems (Los Angeles, California) said it would be undertaking a user preference study under the supervision of a third-party institutional review board to test the company's first-generation ambulatory ECG device against existing systems using volunteer subjects. Recom said it believes this study will demonstrate its superior ECG signal quality under a range of ambulatory/stress conditions and assist in the final production configuration of the company's device, which was approved by the FDA earlier this year. Recom is preparing for product rollout.
Siemens Medical Solutions' (Malvern, Pennsylvania) Angiography and X-ray Division said it has received FDA marketing clearance for the Axiom Artis U, a moveable, digital C-arm imaging system. The system, which offers four times more generator power than any mobile C-arm system on the market, according to the company, is intended to support a variety of examinations, including angiographic interventions, cardiac interventions and surgical procedures. In order to accommodate space limitations at many facilities, the Axiom Artis U was designed with a small footprint. The design provides the combination of a fixed generator, a high-capacity X-ray tube and the flexibility of a movable C-arm. These configurations are intended to make the Axiom Artis U an ideal solution to accommodate hospital budget concerns and space restrictions, Siemens said.
St. Jude Medical (St. Paul, Minnesota) reported the first North American implant and Canadian regulatory approval of its SJM Epic Supra valve. The implant was performed by Robert Cossette, MD, chief of cardiac surgery at Sacre-Coeur Hospital (Montreal, Quebec), on a 68-year-old man who was diagnosed with aortic valve stenosis. The SJM Epic Supra valve is an aortic supra-annular stented porcine tissue valve. Its design is based on the same platform as the SJM Epic valve, which began U.S. clinical trials in January 2003. Both Epic valves feature the company's Linx anti-calcification technology. The SJM Epic Supra valve was designed with an optimized stent-to-native annulus ratio to provide excellent hemodynamic performance and the sewing cuff and low-profile stent are designed for ease of implant in the supra-annular position. The SJM Epic Supra is available in aortic sizes ranging from 19 mm to 23 mm. Both the SJM Biocor and SJM Epic valves are currently available in Europe, Canada, Latin America and Asia. St. Jude Medical also reported the launch of its Advanced Solutions for the Heart program to increase awareness and education for cardiac device therapy among heart failure (HF) patients and their physicians. The program supports the ongoing communication and care between heart failure patients and their physicians by providing a suite of online, interactive educational and support services. The Advanced Solutions program is being distributed through WebMD Health (Elmwood Park, New Jersey), a provider of health information for physicians and consumers. St. Jude CRT heart failure devices include the Epic HF implantable cardioverter defibrillator (ICD), the Atlas+ HF ICD, the Aescula 1055K left-heart lead and the QuickSite1056K left-heart lead.
Sub-Q (San Clemente, California) received FDA approval for its SureStat Arterial Closure System. SureStat is the next generation of closure technology approved in the U.S. for the extravascular, or outside the vessel, closure of femoral arteries following diagnostic or interventional vascular procedures. The SureStat is designed to be easily positioned to deliver the hemostatic material T-Foam, an enhanced and rapidly resorbable gelatin sponge. SureStat can close 8 Fr and smaller punctures in the femoral artery following diagnostic or interventional catheterization procedures. SureStat reduces time to hemostasis, time to ambulation and time to eligibility for hospital discharge, Sub-Q said.
ThermoGenesis (Rancho Cordova, California) has received notice from the U.S. Patent and Trademark Office of the issuance of the third in a series of patents describing a 3-D, compartmentalized bag configured to provide cryopreservation for blood cells, including stem cell rich fractions of blood. The company's patent portfolio includes 21 issued and seven pending U.S. patents. The BioArchive System is a computer-driven robotic system to allow users to cryopreserve and archive up to 3,626 units of blood components in -196 degrees C liquid nitrogen.
Zoll Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and software solutions, said that the FDA has granted marketing clearance for the Lifecor Life-Padz WCD 3000S System, a next-generation, wearable cardioverter defibrillator. With this clearance, Zoll can begin to market and distribute this product to hospitals in the U.S. This device is indicated for adult patients who are at risk for sudden cardiac arrest. The Life-Padz WCD 3000S consists of a wearable monitor, a three-lead electrocardiogram (ECG) system, and one set of therapy pads that are applied on the patient's chest and back. The device continuously monitors a patient's heart through the ECG electrodes, documenting critical events. If a life-threatening rhythm is detected, the device automatically delivers an electrical shock to restore a normal heart rhythm.