A Medical Device Daily Staff Report
Guided Therapeutics (Norcross, Georgia) has received CE mark approval for the company's LuViva Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.
"The notification of CE Mark for LuViva is a significant milestone for the company and allows us to begin our European launch later this year, as planned," said Mark Faupel, PhD, president/CEO of Guided Therapeutics. "We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe."
LuViva is a diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix.
The study used to support LuViva's CE mark application showed that the LuViva was able to detect cervical cancer up to two years earlier than the Pap test, human papillomavirus (HPV) test, colposcopy and biopsy. LuViva detected 86.3 percent of the cervical disease cases that had been missed by Pap, HPV tests and biopsy.
CellAegis gets CE mark for autoRIC device
CellAegis Devices (Toronto) received the CE mark for the company's autoRIC device, which allows automation of remote ischemic conditioning (RIC) at the point of care. CellAegis' autoRIC device has been developed for acute care applications in the ambulance, emergency room and other hospital settings, or for chronic treatment in the home.
Remote ischemic conditioning uses sequences of short, controlled periods of reduced or no blood flow (ischemia) in a limb followed by resumed blood flow (reperfusion). By activating innate mechanisms of metabolic protection in the body, RIC has been shown to reduce the larger damage from ischemic reperfusion injury to cardiac and other organs, including myocardial infarctions, cardiac surgery, stroke, trauma, and organ transplantation.
Based on studies in more than 10,000 individuals in more than 66 ongoing and completed clinical trials worldwide as well as key findings reported at medical conferences and published in leading peer-reviewed publications, data have shown that RIC can reduce heart damage by up to 40%-50% in an evolving heart attack, as well as improve left ventricular ejection fraction in left anterior descending coronary artery (LAD) infarction, and is associated with reduced subsequent cardiovascular events late after percutaneous coronary interventions (PCI) and most recently, reduced incidences of contrast-induced nephropathy.
Placed around the arm, CellAegis' autoRIC device is portable and compatible with current standard-of-care treatments.
pSivida authorized for Iluvien DME treatment
pSivida (Watertown, Massachusetts), a maker of sustained release, drug-delivery products for treatment of back-of-the-eye diseases, said the National Security Agency of Medicines and Health Products (L'Agence Nationale de Sécurité du Médicament et des Produits de Santé) has granted marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, serving as the Reference Member State (RMS), delivered a positive outcome for Iluvien along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The French authorization is the fourth national approval in the EU, preceded by Austria, Portugal and the UK.
"We are pleased our product has received marketing authorization in France. We now have marketing authorization in four of the seven targeted EU countries," said Paul Ashton, president/CEO of pSivida. "We look forward to ILUVIEN receiving approval in the three remaining CMS countries, Germany, Italy and Spain, in the coming months."
Iluvien is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. pSivida is developing an insert of the same design for the treatment of uveitis affecting the posterior of the eye.
Blockade gets CE mark for coil system
Blockade Medical (Irvine, California) received the CE mark for its Barricade Coil System. The system is designed to remove or endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The Barricade Coil System provides the neurovascular specialist with a complete coil embolization line that can occlude complex neurovascular aneurysms and other vascular abnormalities.
The company believes the Barricade Coil System line of embolization coils will allow physicians and hospitals to safely and efficiently provide therapeutic options for treating cerebral aneurysms. The Barricade Coil System is approved in 10 & 18 framing, filling and finishing coil configurations.
"The use of platinum microcoils to treat intracranial aneurysms will continue to expand the neurovascular market. Coil embolization is the standard of care and is proven to be safe and effective for both ruptured and unruptured aneurysms. It is because of this safety and efficacy record that coil embolization will remain the standard of care in aneurysm treatment for years to come. The Barricade Coil System is our first product offering, which Blockade plans to complement with additional products in 2013," said company CEO Gibb Clarke.
Blockade Medical is a privately held medical device company focused on the endovascular management of hemorrhagic stroke and neurovascular disease.