A Medical Device Daily Staff Report
Neovasc (Vancouver, British Columbia), reported that it has received the CE mark designation for its Reducer product for the treatment of refractory angina.
The Reducer is designed to treat patients who suffer from refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle. Refractory angina currently affects an estimated one million patients in Europe, who often lead severely restricted lives. The incidence of refractory angina is growing, yet current treatment options are limited.
The Reducer is implanted in the coronary sinus vein using minimally invasive techniques that are similar to implanting a coronary stent. By modulating blood flow from the coronary sinus, the Reducer acts to increase the perfusion of oxygenated blood to certain areas of the heart muscle, thereby reducing the pain and disability caused by the condition.
"The Reducer's CE mark designation is good news for European refractory angina patients, who previously had exhausted available treatment options but who will now have access to this novel treatment for relieving their symptoms and improving their quality of life," said Dr. Shmuel Banai, medical director of Neovasc. "In addition, the Reducer is implanted using a procedure that is minimally invasive and requires less than 20 minutes to complete."
Results of a published prospective three-year clinical study have demonstrated that the Reducer is safe and effective at providing relief of angina symptoms in refractory angina patients. Neovasc is presently enrolling patients in the COSIRA Coronary Sinus Reducer for Treatment of Refractory Angina (COSIRA) trial, a multicenter, sham-controlled, randomized, double-blinded study. COSIRA has been designed to provide additional controlled, statistically significant data to further demonstrate the clinical efficacy of the Reducer and to support physician education and marketing efforts. It also will support additional regulatory applications to make the Reducer available to the millions of refractory angina patients worldwide who could potentially benefit.
"We are very pleased to have received CE mark designation to treat this critical patient population with high unmet need," said Alexei Marko, CEO of Neovasc. "In the immediate term we will continue to focus on completing enrollment in the COSIRA trial in order to obtain additional data that we expect will be very valuable in supporting medical education and marketing activities for the Reducer. We are currently evaluating a number of options for European commercialization and look forward to distributing the Reducer in select European markets beginning in 2012."
Midatech begins nanoparticle clinical trial
Midatech (Oxford, UK), a developer of nanomedicines, reported that it has received Swissmedic approval to start the first-in-man clinical trial with insulin-coated gold nanoparticles, which will be coordinated through its Swiss subsidiary PharMida.
The trial is designed to assess the safety profile of insulin-coated gold nanoparticles when applied in transbuccal film to healthy volunteers. The study will be performed in a clinical research unit near Basel, Switzerland and results of the trial are expected during 1Q12.
Midatech has developed ultra-small gold nanoparticles (GNP, < 2 nm) that act as artificial atoms that are covalently surface-passivated with a mixed carbohydrate/organic layer (corona). The corona is designed to non-covalently bind and stabilize multiple copies of bioactive peptides like insulin and glucagon-like peptide-1 (GLP-1). Extensive pre-clinical studies with GNP and peptide-GNP have demonstrated favorable PK properties and a clean safety profile in studies with single and multiple dosing by oral, intravenous, subcutaneous and transbuccal route in various animal species.
"This is the first time that solid core nanoparticles of this size and nature will enter human clinical trials," Thomas Rademacher, chairman/CEO of Midatech said. "Based on the excellent preclinical and toxicology results obtained for Midatech's gold nanoparticles in multiple animal models, we are pleased to move to the next stage of development and test the safety of our nanoparticles in human clinical trials. We are also pleased that our Spanish-based IMP Licenced manufacturing subsidiary, Midatech Biogune SA, will be able to provide clinical-grade material for these studies."
Midatech has a collaboration with MonoSol Rx (Warren, New Jersey) to develop products by combining its proprietary gold-nanoparticle technology with MonoSol's PharmFilm drug delivery technology and a joint venture with Immunotope (Doylestown, Pennsylvania) to develop nanoparticle based immunotherapeutic cancer vaccines for the delivery of peptide antigens.
Torax receives CE mark for Fenix system
Torax Medical (St. Paul, Minnesota) has received CE Mark for its Fenix continence restoration system, a new approach to the treatment of fecal incontinence (FI). While studies suggest FI is more prevalent in women and increases with age, men and women of all ages can be affected and for these people there are few treatment options. Torax anticipates first commercial implants in November at specialized medical centers in Europe.
"The Fenix continence restoration system represents a promising new treatment option for patients suffering from this debilitating problem. We plan to work with medical centers which specialize in the treatment of fecal incontinence as we introduce the Fenix system in European markets," said Todd Berg, CEO of Torax.