Here’s a roundup of recent clinical trial and scientific study news:
- Cameron Health closes study enrollment for S-ICD
Cameron Health Inc. completed enrollment in its pivotal FDA clinical study of the S-ICD System, which the company said is the world’s only completely subcutaneous implantable defibrillator.
Cameron Health plans to submit data from this pivotal study to the FDA in late 2011 requesting marketing approval for the S-ICD System in the U.S.
The S-ICD System pivotal study is a prospective multicenter, single-arm study design approved by the FDA under an investigational device exemption (IDE). Clinical investigators enrolled 330 patients at risk for sudden cardiac arrest (SCA) at 33 centers in the United States, Europe and New Zealand. The pivotal study has primary clinical endpoints of arrhythmia conversion efficacy and complication-free rate at six months for qualified patients.
The S-ICD System won CE mark approval in 2009 based on data that was published in the July 2010 issue of the New England Journal of Medicine. Approximately 800 patients have been implanted with the S-ICD System worldwide.
The S-ICD System is unique in that the implantation of the system is entirely subcutaneous, eliminating the need for electrical wires (leads) to be placed in the heart. The S-ICD System detects highly accelerated and disorganized heart rhythms and provides a jolt of electricity (or shock) to restore the heart’s normal rhythm and prevent SCA. Left unaddressed, these disorganized heart rhythms are often fatal.
- Docs recommend ultrasound prior to MRI for rotator cuff tear diagnosis
While ultrasound is usually viewed as more cost effective, MRI is most often used to evaluate the rotator cuff. When performing a cost utility analysis, utilizing an ultrasound as the initial imaging test for rotator cuff tear, along with pre-operative MRI to identify alternative and concurrent diagnoses, can be a very effective hybrid imaging strategy, according to research being presented at the 2011 American Roentgen Ray Society’s annual meeting. The study, performed at Duke University Medical Center in Durham, NC and Rush University Medical Center in Chicago, IL, utilized three evaluation techniques: the use of ultrasound alone, MRI alone, and a hybrid strategy of ultrasound for all patients followed by MRI for those patients who required surgery.
- Synovis touts publication of Veritas data in Journal of the American College of Surgeons
Synovis Life Technologies Inc. (NSDQ:SYNO) announced the online publication of a study comparing the biomechanics of crosslinked and non-crosslinked biologic meshes, including the company’s Veritas Collagen Matrix, in the Journal of the American College of Surgeons. Published by Principal Investigator Dr. Brent Matthews in the Department of Reconstructive Surgery at Washington University, St. Louis, the study confirms the favorable attributes of Veritas in abdominal wall repair, such as ventral hernia surgery.
- Medtronic reports positive study results for Reveal XT insertable cardiac monitor
Medtronic Inc. (NYSE:MDT) announced findings from the DISCERN AF trial, which utilized the company’s Reveal XT insertable cardiac monitor to conduct long-term monitoring to assess the incidence of symptomatic versus asymptomatic atrial fibrillation (AF) episodes in patients before and after undergoing radiofrequency (RF) ablation as compared to the AF status reported prior to the procedure. The clinical trial showed an 86 percent reduction in total AF burden (total amount of time spent in atrial fibrillation) from 2.0±0.5 hours per day per patient pre-ablation to 0.3±0.2 hours per day per patient post- ablation (p=0.005), with 56 percent of the total burden being asymptomatic.
- Hercules trial shows reduction in systolic blood pressure and new data on renal artery stenting
A substance secreted by the heart that is associated with congestive heart failure and renal failure is not predictive of reduction in systolic blood pressure in patients treated with renal artery stenting, according to results from the HERCULES trial presented as a Late-Breaking Clinical Trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2011 Scientific Sessions in Baltimore. The HERCULES trial is a prospective, multicenter trial of renal stenting in patients who have blockages to their renal arteries, which can worsen hypertension and threaten kidney function.
- Study: Fidelis fracture rates more prevalent in CRT-ICD devices
Fracture rates with Medtronic’s Sprint Fidelis lead are significantly higher among patients who received an implantable cardioverter defibrillator with cardiac resynchronization therapy (ICD-CRT) than those who received an ICD alone, a new study demonstrated. Presenting the results of an analysis of the Resynchronization/Defibrillation for Ambulatory Heart Failure Trial (RAFT) at the Heart Rhythm Society (HRS) 2011 Scientific Sessions, investigators report that the annual fracture rate among ICD patients was 1.0% compared with 2.4% among those who received the combined ICD-CRT device, according to HeartWire.
- New experience with subcutaneous-lead ICD indicates device as effective as competitors
Growing experience with an ICD that has an entirely subcutaneous lead system (such as Cameron Health’s S-ICD) continues to suggest that it’s as effective at stopping potentially lethal arrhythmias as a transvenous-lead ICD, but it’s also highlighting some limitations to balance its undeniable attributes, reports HeartWire. In a 98-patient experience from three centers in the Netherlands, reported the 2011 HRS conference, the device successfully terminated all 42 episodes of sustained and nonsustained ventricular tachycardia (VT) in the cohort over an average of nine months, writes HeartWire.