
Here’s a roundup of recent clinical trial news:
- FDA approves Medtronic trial of CoreValve implant
Medtronic Inc. (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Medtronic CoreValve System for transcatheter aortic valve implantation (TAVI).
Read more - VertiFlex Inc. Announces 200 Patients Enrolled in Superion IDE Trial
VertiFlex Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that 200 patients have been enrolled in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).
Read more - Three-Year Follow-Up Data Confirm Safety and Survival Benefit in Chinese Liver Failure Patients Treated With ELAD Bioartificial Liver
Vital Therapies Inc. (VTI) today announced that a poster is being presented at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston on Tuesday, November 2nd. It confirms that previously reported findings of improved transplant free survival (TFS) in Chinese subjects with acute-on-chronic liver failure (ACLF) treated with the ELAD bioartificial liver support system are maintained for up to three years.
Read more - 9-Year Study by the Skull Base Institute Confirms Success of “Keyhole” Procedure in Removing Brain Tumors Linked to Hearing Loss
Results from a newly released nine-year study is bringing newfound hope to the approximately 3,000 Americans diagnosed each year with acoustic neuromas (AN), little-known brain tumors that can have devastating and even fatal consequences for sufferers.
Read more - Cardiogenesis Enrolls First Two Patients in Its Feasibility Study of the PHOENIX Combination Delivery System
Cardiogenesis Corporation (OTC:CGCP), a leading developer of surgical products used in the treatment of diffuse coronary artery disease, reported the enrollment of the first two patients in its PHOENIX Feasibility Study.
Read more - Aurora St. Luke’s Medical Center Opens a New Trial on the Use of Inhaled Nitric Oxide During Right Heart Catheterization
Aurora St. Luke’s Medical Center has begun an open label, non-randomized pilot research study to evaluate the safety, tolerability and device performance of the GeNO NITROsyl Delivery System during right heart catheterization in subjects being evaluated for orthotopic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation.
Read more - Safety Confirmed of Breast Augmentation With Autologous Fat Stem Cells
Since 2003, breast augmentation utilizing stem cells from autologous fat has been developed enabling silicon-free breast reconstruction following cancer surgery. Till now though, it was unclear whether this might reactivate the cancer again. However, University of Pittsburgh researchers led by Prof. Albert Donnenberg have now demonstrated that stem cell-enriched autologous fat is safe even in the presence of inactive tumor cells.
Read more - Ocular Therapeutix Completes Proof of Principle Study with Moxifloxacin-Loaded Punctum Plugs
Ocular Therapeutix, Inc. announced today the completion of a successful Proof of Principle clinical study with their novel sustained drug delivery moxifloxacin punctum plug.
Read more - Incept BioSystems Completes First Human Clinical Trial of the SMART Start Embryo Culture System and Submits 510(k) Application to the FDA
Incept BioSystems Inc. (“Incept”), a privately-held biomedical device company using patented, microfluidic technology developed at the University of Michigan, announced today the completion of the first U.S. human clinical trial of its proprietary, SMART Start Embryo Culture System, and the recent submission of a 510(k) application to the U.S. Food & Drug Administration (“FDA”). A decision as to market clearance for the device is expected from the FDA sometime in 2011.
Read more - Tryton Announces First Patient Enrollment in E-Tryton Italy Registry of the Tryton Side Branch Stent System
Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced that the first patient has been enrolled in E-Tryton Italy, a registry study of the company’s Tryton Side Branch Stent System.
Read more - Myriad Genetics’ PROLARIS Test Accurately Predicts Survival With Prostate Cancer
Myriad Genetics, Inc. (NSDQ:MYGN) announced today that based on recent clinical validation, its newest molecular diagnostic product, PROLARIS, accurately predicts survival with prostate cancer.
Read more - Covidien Announces New Evidence That Underscores Clinical Value of Hernia and Abdominal Wall Repair Products
Covidien (NYSE:COV), a leading global provider of healthcare products, announced that its hernia and abdominal wall repair products were featured in 18 podium presentations at the 32nd International Congress of the European Hernia Society (EHS).
Read more - Randomized Clinical Trial of OrbusNeich’s Genous Bio-engineered R stent in China Completes Patient Enrollment
OrbusNeich today reported the completion of patient enrollment in a randomized clinical study of its Genous Bio-engineered R stent at 11 sites in China.
Read more - Human Studies Commence Using Magnetecs Robotic Catheter Guidance System
Magnetecs Corporation, a designer and manufacturer of robotic systems for minimally invasive surgical procedures, today reported that human studies have commenced using the Company’s Catheter Guidance Control and Imaging (CGCI) system for patients with arrhythmia, or irregular heart beat.
Read more - Geron Initiates Clinical Trial of Human Embryonic Stem Cell-Based Therapy in Patients with Spinal Cord Injury
Geron Corporation (Nasdaq: GERN) today announced the enrollment of the first patient in the company’s clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1.
Read more - BrainStorm Receives Approval to Begin Clinical Trial of Adult Stem Cell Therapy in Patients with ALS
BrainStorm Cell Therapeutics Inc. (OTC:BCLI), a leading developer of adult stem cell technologies and therapeutics, today announced that the Israeli Ministry of Health (MOH) has granted clearance for a Phase I/II clinical trial using the company’s autologous NurOwn stem cell therapy in patients with amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s Disease.
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