Svelte Medical Systems Inc. closed a six-month follow-up analysis for the first clinical trial of its Acrobat angioplasty system.
CEO Mark Pomeranz said the "excellent" results from the Europe and South America-based trial are a "significant milestone" for the New Providence, N.J.-based company.
The company calls the Acrobat device an "all in one" stenting system.
"The system has the ability to reduce time and costs in a procedure by allowing more lesions to be treated without pre-dilatation. The small size and flexibility of the system are well suited for the radial access approach," Chief of Coronary Interventions at Institute Dante Pazzanese de Cardiologia, Sao Paulo, Dr. Alexandre Abizaid said in prepared remarks.
Svelte plans to present the results of the trial at upcoming international congresses. The company won CE Mark approval for European distribution for the device last August and plans to begin U.S. clinical trials in 2011.
Here’s a roundup of recent clinical trial and scientific study news:
- Gore treats first U.S. patient with new endoprosthesis
W. L. Gore & Associates reported the first clinical use in the U.S. of its VIABAHN endoprosthesis with Heparin Bioactive Surface on a lower profile delivery system. The VIABAHN device is designed to percutaneously treat Superficial Femoral Artery (SFA) and iliac peripheral artery disease by relining the native vessel. The first U.S. procedure to treat a patient using the device was performed by Dr. Tony Das at Texas Health Presbyterian Hospital Dallas.
- Two TranS1-sponsored studies to publish
TranS1 Inc. (NSDQ:TSON) announced that two noteworthy clinical papers have been accepted for publication in peer-reviewed journals. In addition, TranS1 updated its revenue guidance for the first quarter of 2011. The first paper reviews efficacy data from a four site, 156 patient study with two-year follow up and demonstrates a 94 percent fusion rate. This paper has been accepted for publication in SPINE. The second paper is a 9,152 patient retrospective safety study that shows a 1.3 percent complication rate. This paper has been accepted for publication in the SAS Journal.
- Manhattan Scientifics enters clinical trial
Manhattan Scientifics Inc. (OTC:MHTX) enrolled its first 35 patients to measure leukemia cells using a nanotechnology-based magnetic imaging method developed by Senior Scientific LLC, which has licensed the technology to Manhattan.
- Covidien touts interim data on hernia repair mesh
Covidien plc (NYSE:COV) announced interim results of its multicenter, international, prospective study comparing use of its Parietex ProGrip self-fixating mesh to the traditional Lichtenstein repair, the gold-standard technique for inguinal hernia repair. The data were presented during a podium presentation at Hernia Repair 2011, the 14th Annual Meeting & Scientific Program of the American Hernia Society. The interim data demonstrate that patients who received Parietex ProGrip self-fixating mesh during inguinal hernia repair experienced significantly less early pain compared to those whose hernias were repaired using the standard Lichtenstein method, according to the company.
- Heart damage alleviated and reversed after stem cell injections: Study
Researchers showed for the first time that stem cells injected into enlarged hearts reduced heart size, reduced scar tissue and improved function to injured heart areas, according to a small trial published in Circulation Research: Journal of the American Heart Association. The treatment is experimental and needs to be tested in larger trials, but it is promising for heart patients.
- Genomic Health touts breast cancer test studies
Genomic Health, Inc. (NSDQ:GHDX) touted results from nine studies utilizing the Oncotype DX test in early-stage breast cancer patients at the 12th Annual St. Gallen International Breast Cancer Conference in St. Gallen, Switzerland. The studies included region-specific decision impact data that demonstrated the knowledge of a patient’s Recurrence Score (RS) result changed physicians’ treatment recommendations in approximately 33 percent of cases in the United Kingdom, Germany and Spain, which is similar to what has been shown in U.S.
- Advanced Cardiac begins European trial for atrial arrhythmia catheter system
Advanced Cardiac Therapeutics Inc. announced that the first patients have been enrolled in a first-in-man CE Mark clinical trial of the safety and performance of the company’s TEMPASURE cardiac ablation catheter. The TEMPASURE system is the world’s first RF cardiac ablation catheter to offer both saline irrigation and temperature-sensing technology.
- Drug delivery system could improve cancer treatment
Scientists in Syracuse University’s Chemistry Department have created a new drug delivery system expected to advance the effectiveness of cancer-killing drugs. It uses gold nanoparticles with attached DNA that binds to a proven anti-cancer drug, Doxorubicin or DOX. Preliminary tests indicate this delivery device has the potential to significantly improve the results of cancer chemotherapy. DOX is currently used against cancers of the breast, bone marrow, thyroid, bladder, ovary, small cell lung and several others.
- SAPPHIRE trial indicates carotid stenting economically feasible
An economic analysis of the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial — a randomized comparison of carotid endarterectomy with carotid stenting using distal protection — shows that while there are higher costs associated with carotid stenting, the procedure is economically feasible. The results were published in the March 2011 issue of Catheterization and Cardiovascular Interventions.
- 18 more coronary artery disease gene loci found
Another 18 loci implicated in coronary artery disease have been discovered by three different groups, bringing the total number of genes now known to be involved in coronary artery disease up to about 30, reports heartwire.
- Study: Sanuwave Dermapace more effective than hyperbaric oxygen therapy for treating foot ulcers
Sanuwave Health Inc. (OTC:SNWV) announced the publication of research conducted in Taiwan comparing the effectiveness of the Company’s dermaPACE device with hyperbaric oxygen therapy (HBOT) in treating chronic diabetic foot ulcers. The study, entitled “Treatment of Diabetic Foot Ulcers: A Comparative Study of Extracorporeal Shockwave Therapy and Hyperbaric Oxygen Therapy,” by Wang, C.J. et al., appeared in the online edition of Diabetes Research and Clinical Practice as an ePublication ahead of print.