Here’s a roundup of recent clinical trial and scientific study news:
- Medtronic launches CoreValve clinical trial
Medtronic Inc. (NYSE:MDT) today announced the beginning of its Medtronic CoreValve U.S. pivotal clinical trial in the United States. The first CoreValve transcatheter aortic valve implantation (TAVI) procedure was performed by David H. Adams, M.D., and Samin K. Sharma, M.D., at The Mount Sinai Medical Center in New York City. The Medtronic CoreValve System, a revolutionary treatment alternative to open-heart surgery for patients with severe aortic stenosis, will be investigated in more than 1,200 patients at up to 40 U.S. clinical trial sites. A second CoreValve case took place this week at El Camino Hospital in Mountain View, Calif.; St. Francis Hospital, The Heart Center in Roslyn, N.Y, also has been activated in the trial and is screening patients.
- Cook Medical releases data from Stable trial of endovascular treatment of aortic dissection
Study investigators reported positive steps in Cook Medical’s efforts to gain FDA approval of the treatment assessed in the STABLE clinical trial, designed to evaluate the safety and efficacy of a proximal endograft and a distal uncovered stent for the endovascular treatment of Type B aortic dissection for purposes of seeking FDA approval. The findings were presented by Dr. Joseph Lombardi at the 37th annual VEITHsymposium. The trial is the first and only one of its kind to focus on a device uniquely designed for the endovascular treatment of Type B aortic dissection. The system as a whole is an investigational device not available in the United States.
- Tryton Announces Enrollment of First Patient in U.S. Pivotal Study of Side Branch Stent
Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced that the first patient has been enrolled in the pivotal trial to evaluate the Tryton Side Branch Stent System for the treatment of coronary artery disease.
- Strict Heart Rate Control Provides No Advantage Over Lenient Approach
Strictly controlling the heart rate of patients with atrial fibrillation provides no advantage over more lenient heart rate control, experts report in a focused update of the 2006 guidelines for the management of patients with atrial fibrillation.
- Cost-Effectiveness of Cyberonics’ VNS Therapy System for Epilepsy Reinforced By 1,600-Patient Emory University School of Medicine Study
Cyberonics, Inc. (Nasdaq: CYBX) announced today that the VNS Therapy System, the only FDA-approved implantable medical device for the treatment of refractory epilepsy, was featured in 22 poster presentations and in the Plenary II session on neurostimulation at the annual American Epilepsy Society Meeting that took place recently in San Antonio, Texas.
- Aethlon Medical Demonstrates Ability to Capture Colorectal and Lymphoma Cancer Exosomes
Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that it has demonstrated the ability to capture immunosuppressive exosomes derived from individuals with lymphoma and colorectal cancer.
- Cardio3 BioSciences Announces Significant Progress in its Programme for the Treatment of Acute Myocardial Infarction
The Belgian biotechnology company, Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces positive pre-clinical results from its in-house product candidate C3BS-GQR-1, a “cardiopoietic” cocktail designed to treat patients suffering from acute myocardial infarction in order to protect cardiac tissue from damage and direct heart stem cells to mature and restore pump function. This therapeutic candidate diversifies the product portfolio of Cardio3 BioSciences offering regeneration without the need for stem cell injection. This newest innovation builds on an ongoing collaboration with Mayo Clinic investigators.
- Halt Medical Presents Strong Results of International Fibroid Studies at National Institutes of Health Global Congress
Women suffering from uterine fibroids, a debilitating condition that affects more than seven million women in the U.S., may soon have reason for hope. Halt Medical, a biomedical company based in the San Francisco Bay Area, is developing a minimally invasive procedure for treating the condition. The company recently presented their findings from studies in Latin America at the NIH Global Fibroid Congress.
- Sequenom CMM Commences Pivotal Clinical Validation Study for Its SensiGene Trisomy 21 Laboratory Developed Test
Sequenom, Inc. (Nasdaq: SQNM) today announced that the company’s wholly-owned reference laboratory, the Sequenom Center for Molecular Medicine (Sequenom CMM), has authorized commencement of a pivotal clinical validation study. This validation study is designed to evaluate the clinical performance of the SensiGene T21 Laboratory Developed Test (LDT) for the detection of an overabundance in maternal blood of chromosome 21, which is associated with fetal chromosome 21 aneuploidy. Testing of the clinical specimens will be performed at the Sequenom CMM facility in San Diego.
- Particle Sciences Develops Wax Nanoparticles that Enhance Immune Response to Antigens
Particle Sciences Inc. (PSI), a leading pharmaceutical CRO has formulated a series of wax nanoparticles that, when coupled with an antigen, enhanced its immunogenicity, increasing both systemic and the mucosal immune response. The work is described in Vaccine, 2010 Dec. 8 in an article titled “Carnauba wax nanoparticles enhance strong systemic and mucosal cellular and humoral immune responses to HIV-gp140 antigen.”