Cardiac resynchronization-therapy defibrillators reduced the mortality rate by 29 percent in patients with mild symptoms of heart failure, according to a study released by Medtronic Inc. (NYSE:MDT) at the annual meeting of the American Heart Assn. in Chicago.
The landmark study could prove to be a boon for not only for the Fridley, Minn.-based medical device monolith, but also for other big names in the CRT-D space, such as Boston Scientific Corp. (NYSE:BSX) and St. Jude Medical Inc. (NYSE:STJ).
The nearly 1,800-patient study examined subjects with mild-to-moderate symptoms of heart failure in Canada, Europe, Turkey and Australia for at least 18 months and for an average of 40 months. Mortality alone and combined mortality/hospitalization rates slid by 25 percent compared with patients treated with implantable cardiac defibrillators, according to the study, which was also published in the New England Journal of Medicine.
Cardiologists believe the device can help promote "reverse remodeling." The left ventricles of patients with cardiac failure often become enlarged; CRT-D devices can help reduce the size of such patients’ hearts and improve the function of the left ventricle.
In an editorial on the study in the NEJM, Dr. Arthur Moss of the University of Rochester School of Medicine and Dentistry called the results "indeed breathtaking," but cautioned that "device- or implant-related complications and device-related hospitalizations during follow-up were twice as frequent in the ICD–CRT group as in the ICD group."
The study also raises an economic question: Who will pay for the devices, which cost about $10,000 more than standard ICDs, according to the Wall Street Journal.
“How is this going to get funded, and who’s going to pay for it?” Dr. Eric Topol, cardiologist and chief academic officer at Scripps Health in LaJolla, Calif., asked the newspaper, adding that the reduced hospitalization rate reported in the study “may actually present a net reduction in costs from a societal standpoint.”
But Dr. William Abraham, chief of cardiology at Ohio State University, said the lower death rate will mean increased adoption no matter the cost. Abraham was the lead investigator on a Medtronic CRT-D study 10 years ago, according to the newspaper.
“There will be no way to keep the floodgates closed,” he told the Journal.
Here’s a roundup of recent clinical trial news:
- HeartWare achieves primary endpoint with 92% success in pivotal bridge-to-transplant clinical trial, ADVANCE
HeartWare International Inc. (NSDQ:HTWR) announced that data from its pivotal bridge-to-heart-transplantation study, ADVANCE, showed that 92 percent of the investigational device patients met the per protocol primary endpoint of the trial, which was defined as alive on the originally implanted device, transplanted or explanted for recovery at 180 days.
- Boston Scientific begins patient enrollment in clinical trial assessing deep-brain stimulation for Parkinson’s disease
Boston Scientific Corp. (NYSE:SX) today announced the first implantation of its Vercise™ deep-brain stimulation system as part of the VANTAGE clinical trial. VANTAGE is a multi-center, prospective trial designed to examine the improvement of motor function in approximately 40 European patients implanted with the Vercise DBS System for the treatment of Parkinson’s disease.
- A new solar-powered blood pressure measuring device for low-resource settings
The management of high blood pressure is particularly inadequate in low-income countries, where the unavailability of a reliable, durable, and affordable BP-measurement device is a major obstacle to accurate diagnosis. Recognizing this, a World Health Organization committee was established to correct this deficiency by influencing manufacturers to produce a device according to predetermined criteria and to demonstrate the suitability of the device for low resource settings. A device, which fulfilled stipulated criteria in being inexpensive, semiautomated, and solar powered, was validated according to the International Protocol of the European Society of Hypertension; it was then subjected to field testing in 716 subjects from 2 centers in Uganda and 1 in Zambia.
- Seven U.S. medical centers begin study to change femoral artery cath lab access
Patient enrollment has begun in the RECITAL (A Patient Registry Evaluating Closure Following Access with the Arstasis One Access System) Study. The non-randomized, prospective, post-approval study is anticipated to enroll up to 500 patients in at least seven U.S. hospitals. The goal of the study is to observe the clinical safety and effectiveness of the Arstasis One Access System in patients undergoing diagnostic angiography procedures through the femoral artery.
- BioControl wins IDE approval for INOVATE-HF study
BioControl Medical announced Food & Drug Administration conditional approval for its Investigational Device Exemption application and pivotal clinical trial protocol to begin evaluating the CardioFit system for the treatment of congestive heart failure. The company will begin enrollment in the INOVATE-HF (INcrease Of VAgal TonE in chronic Heart Failure) clinical trial.
- NICOM system for noninvasive hemodynamic monitoring found to be an effective tool for identification of acute heart failure in the emergency department
A study performed by investigators from the Emergency Department of the Cleveland Clinic Foundation, published in the American Journal of Emergency Medicine, finds that Cheetah Medical’s NICOM system is effective in identification of acute heart failure and in differentiating it from other acute situations with similar clinical presentations.
- Flexible Stenting Solutions presents first-in-man clinical experience with the FlexStent femoropopliteal SE stent system
Final first-in-man clinical results on the use of the FlexStent femoropopliteal SE stent system were presented recently at the VIVA conference in Las Vegas by Dr. Andrew Holden of Auckland City Hospital. The clinical results originated from Flexible Stenting Solutions Inc.’s FIM study, conducted in New Zealand by principle investigator Dr. Andrew Holden, and FSS’s supplementary study conducted in Germany by principle investigator Dr. Dierk Scheinert of University of Leipzig – Heart Center.
- Miracor reports successful first-in-man clinical outcome for its PICSO system
Miracor Medical Systems GmbH announced today the successful first-in-man clinical outcome for its Pressure-controlled Intermittent Coronary Sinus Occlusion System, designed to improve acute coronary syndrome revascularization following primary percutaneous coronary intervention.
- Non-invasive glucose measurements in the eye highly effective in clinical study
Freedom Meditech Inc. announced results of a clinical study that showed a high correlation between low to high blood glucose levels and non-invasive glucose measurements in the eye in a live animal model.
- Stem cell study shows benefits in treatment of spinal injuries
Dr. Geeta Shroff, founder & medical director of Nutech Mediworld, presented the summary results of a retrospective clinical study of human embryonic stem cell therapy in patients with chronic spinal cord injury at the 2nd Annual World Stem Cells & Regenerative Medicine Congress Asia 2010.
- Results of two new clinical studies show promise of Mobile Health to combat obesity epidemic
BodyMedia Inc. recently announced the findings from two clinical studies that yielded promising results showcasing body monitoring devices’ integral role in the current public health dialogue.
- Interleukin Genetics and the University of North Carolina at Chapel Hill announce additional clinical study findings on osteoarthritis progression
Interleukin Genetics Inc. (OTC:ILIU) and the Thurston Arthritis Research Center at the University of North Carolina at Chapel Hill announced today additional findings from their previously reported 1,154-patient longitudinal study to evaluate the role of genetic factors in osteoarthritis progression.
- US HIFU announces that 18 recurrent prostate cancer clinical trial sites are open for enrollment
USHIFU LLC announced that 18 clinical trial sites involved in the recurrent prostate cancer trial have been initiated and opened.