Here’s a roundup of the latest dealflow and investment news:
- Boston Scientific Begins Clinical Trial Enrollment in China for PROMUS Element Everolimus-Eluting Stent
Boston Scientific Corp. (NYSE:BSX) announced the beginning of patient enrollment in the PLATINUM China clinical trial, which is designed to evaluate the safety and effectiveness of the Company’s PROMUS Element Everolimus-Eluting Platinum Chromium Coronary Stent compared to the TAXUS Liberte Paclitaxel-Eluting Coronary Stent in the treatment of patients with a single de novo atherosclerotic lesion. PLATINUM China is a prospective, randomized trial that will enroll 500 patients at 15 sites in China. Clinical data from the trial will be used to support approval of the PROMUS Element Stent by the State Food and Drug Administration of the People’s Republic of China.
Read more - Boston Scientific Completes Enrollment in EVOLVE Clinical Trial to Evaluate SYNERGY Drug-Eluting Coronary Stent
Boston Scientific announced the completion of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of the Company’s fourth-generation SYNERGY Coronary Stent. The randomized, single-blind, non-inferiority trial will compare the SYNERGY Stent to the PROMUS Element Everolimus-Eluting Coronary Stent in patients with a single de novo native coronary artery lesion. The trial enrolled 291 patients at 29 sites in Europe, Australia and New Zealand, and completed enrollment four months ahead of schedule.
Read more - Cardiac Concepts Inc. Announces the First U.S. Implant of the RespiCardia System to Treat Central Sleep Apnea
Cardiac Concepts Inc. announced the first U.S. clinical implant of the RespiCardia System at The Ohio State University Medical Center, Columbus, Ohio. The RespiCardia System is a fully implantable device that is designed to restore more natural breathing patterns in patients with central sleep apnea, a sleep disorder characterized by a lack of respiratory effort by the diaphragm. The procedure was performed by Dr. Ralph Augostini, Assistant Professor of Clinical, Cardiovascular Medicine at The Ohio State University, on a 61 year old male patient with a history of central sleep apnea and atrial fibrillation.
Read more - Nfocus Neuromedical Luna Aneurysm Embolization System Demonstrates Clinical Utility in Brain Aneurysm
Nfocus Neuromedical Inc., an innovative medical device company with a focus on the next generation treatment for brain aneurysms, announced the presentation of preliminary clinical experience for the company’s Luna Aneurysm Embolization System (AES). Drs. Gyula Gal and Karlis Kupc of the Departments of Radiology University Hospitals in Odense, Denmark and Riga, Latvia presented results from their first use of the Luna AES at the annual ABC-WIN meeting here.
Read more - BD and Rady Children’s Hospital-San Diego Announce Innovative Pilot Project to Reduce Environmental Impact of Sharps Disposal
BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, and Rady Children’s Hospital-San Diego announced that they have implemented an innovative pilot program at the Hospital that is designed to safely divert a significant percentage of BD sharps waste from landfills and utilize the recycled materials.
Read more - Lowering Blood Pressure in Middle-Aged Women Reduces Heart Disease Risk
Large numbers of middle-aged women worldwide could reduce their risk of developing cardiovascular disease (stroke, heart attack and heart failure) and its complications by lowering their blood pressure, researchers report in Hypertension: Journal of the American Heart Association.
Read more - Erchonia Laser May Help Cancer Patients with Radiation Treatments
Erchonia Corp., the global leader in low level laser healthcare applications, announces results of a pilot study testing the ability of low level lasers to reduce the negative side-effects of radiation therapy for cancer patients. Patients who undergo aggressive cancer therapies must also endure a host of painful side-effects. An estimated 80 percent suffer from severe toxicity with nearly 50 percent experiencing side-effects so intense they choose to terminate their cancer treatment before completion.
Read more - INVO Bioscience Announces Commencement of Clinical Trial in Brazil to Obtain ANVISA Approval
INVO Bioscience Inc. (OTC:IVOB), a medical device company focused on treatment options for patients diagnosed with infertility, announced the commencement of a 40 patient clinical trial in Rio de Janeiro, Brazil to establish safety, efficacy and comparative in-vitro fertilization (IVF) measures of the INVOcell device. The design for the 40 patient clinical trial has been submitted for approval to the Federal Ethics Committee in Brazil. Upon approval of the trial design, results from the completed clinical study will be submitted to the National Health Surveillance Agency (ANVISA) for the purpose of gaining registration and approval for the sale of the INVOcell device in Brazil.
Read more - Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality
Electronic health records were used in 30 percent of an estimated 1.1 billion annual US patient visits. Clinical decision support was present in 57 percent of these EHR visits (17 percent of all visits). The use of EHRs and CDS was more likely in the West and in multiphysician settings than in solo practices. In only 1 of 20 indicators was quality greater in EHR visits than in non-EHR visits (diet counseling in high-risk adults, adjusted odds ratio, 1.65; 95 percent confidence interval, 1.21-2.26). Among the EHR visits, only 1 of 20 quality indicators showed significantly better performance in visits with CDS compared with EHR visits without CDS (lack of routine electrocardiographic ordering in low-risk patients, adjusted odds ratio, 2.88; 95 percent confidence interval, 1.69-4.90). There were no other significant quality differences.
Read more - Long-Term European Data Released for SUPERA Stent from IDEV Technologies
IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, announced the release of two-year European data from the prominent Leipzig Registry, which tracks patients treated with the SUPERA wire interwoven nitinol stent. The SUPERA stent is CE marked for biliary and peripheral vascular use in Europe. In the United States, the SUPERA stent is currently being studied in an ongoing FDA approved IDE trial for treatment of peripheral arterial disease of the superficial femoral artery (SFA).
Read more - Tryton Announces Enrollment of First U.S. Patient in Pivotal Study of Side Branch Stent
Tryton Medical Inc., the leading developer of stents designed to definitively treat bifurcation lesions, announced that the first U.S. patient has been enrolled in the pivotal trial to evaluate the Tryton Side Branch Stent System for the treatment of coronary artery disease.
Read more - Little-known growth factor enhances memory, prevents forgetting in rats
A naturally occurring growth factor significantly boosted retention and prevented forgetting of a fear memory when injected into rats’ memory circuitry during time-limited windows when memories become fragile and changeable. In the study funded by the National Institutes of Health, animals treated with insulin-like growth factor (IGF-II) excelled at remembering to avoid a location where they had previously experienced a mild shock.
Read more - Shockable cardiac arrests are more common in public than home
Comprehensive NIH study helps explain discrepancy in survival rates between cardiac arrests in public and at home. Cardiac arrests that can be treated by electric stimulation, also known as shockable arrests, were found at a higher frequency in public settings than in the home, according to a National Institutes of Health-funded study appearing in the Jan. 27 issue of the New England Journal of Medicine.
Read more - BrainScope Announces Multi-Center Clinical Study of Head Injury in the United Kingdom
BrainScope Company Inc. announced its sponsorship of a multi-center, observational clinical study, the “B-Ahead U.K. Trial”, utilizing its technology in development to aid in the assessment of traumatic brain injury (TBI) and its milder forms (commonly referred to as “concussion”) in emergency departments in the United Kingdom.
Read more - Boston Scientific Announces First Use of Blazer Open-Irrigated Catheter in U.S.
Boston Scientific announced the first use of the Blazer Open-Irrigated Catheter in the U.S. as part of the BLOCk-CTI clinical trial. BLOCk-CTI is a prospective, randomized trial evaluating the safety and effectiveness of the Blazer Open-Irrigated Catheter in patients with sustained or recurrent Type 1 atrial flutter. The trial plans to enroll up to 240 patients at 22 sites in the U.S.
Read more - US Army Study Shows STB Lifesaving Technology’s FAST Dressing Superior to the Most Effective Currently Available Agents for Controlling Arterial Bleeding
In a study conducted jointly by the US Army Institute of Surgical Research and STB Lifesaving Technologies®, and just published in The Journal of Trauma, STB®’s FAST (Fibrin Adhesive STat) Dressing was shown to be superior to the most effective available agents for controlling severe arterial bleeding.
Read more - Contrast-Enhanced Ultrasound Improves Diagnosis of Medical Conditions in Children
New research released here Thursday shows that “contrast-enhanced ultrasound” (CEUS) can safely improve the diagnosis of a variety of medical conditions in children – without exposing them to ionizing radiation. Dr. Martin Stenzel, a pediatric radiologist at the University Hospital in Jena, Germany, reported that no adverse safety event was found when CEUS was used to image some 50 pediatric patients at his hospital. Stenzel presented his findings at the 16th European Symposium on Ultrasound Contrast Imaging in Rotterdam. The conference, which was co-sponsored by the International Contrast Ultrasound Society (ICUS), featured the latest clinical and research developments in the CEUS field.
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