07.31.13
• GE Healthcare was granted the CE mark for its SenoClaire 3-D breast imaging system, designed to reduce the amount of radiation women are exposed to during breast cancer screening. According to the company, the system uses a low-dose short X-ray sweep around the positioned breast with nine exposures acquired with a “step-and-shoot” method, removing the potential motion from images.
• Stentys SA won expanded indications under the CE mark for the Stenty self-apposing stent, which treats acute myocardial infarction. According to the company, the stent is engineered to solve the dilemma of artery diameter discrepancy. It has a flexible, self expanding design intended to take the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel. The expanded indications were earned on the basis of additional clinical evaluation and now includes specific patient subsets such as those with tapered, aneurysmatic, ectatic (dilated) or very large vessels or those with bypass grafts. Contraindications such as chronic total occlusions and left main bifurcations also have been lifted. These changes allow Stentys to commercialize its self-apposing stent in new market segments that represent approximately 10 percent of all percutaneous coronary interventions in Europe.
• Retina Implant AG was granted the CE mark for its Alpha IMS, a wireless subretinal implant technology. The technology, which has been in global clinical trials since 2005, is designed to restore useful vision in patients blinded by the degenerative eye condition retinitis pigmentosa. The device is a subretinal microchip consisting of a 3 x 3 mm microchip with 1,500 electrodes. According to Retina Implant, to date, 36 patients have received the Alpha IMS microchip. This is the first European regulatory certification for the company and the Alpha IMS device.
• Cormedix Inc. was granted the CE mark for Neutrolin, a catheter lock solution designed to prevent catheter-related bloodstream infections (CRBIs) in hemodialysis patients. Neutrolin comprises an anti-coagulant and broad-spectrum of antibacterial and antifungal combination, which is active against microbes of common nature and restricts biofilm formation. According to Cormedix, it helps in maintaining catheter patency by restricting thrombosis, thereby lessening the requirement for systemic antibiotics and extending the life of central venous catheters. CRBIs and inflammatory complications are considered to be main reasons of morbidity in final stage renal disease hemodialysis patients.
• Integra LifeSciences Holdings Corp. earned the CE mark for its Integra smart cervical solution, a device approved in the European Union for treating degenerative diseases of the cervical spine that require stabilization and fusion of two or more cervical vertebrae. Delivered sterile in a double-blister pack, Integra’s smart cervical solution combines a cervical cage with a synthetic bone substitute, according to the company. The implant is pre-filled and attached to a disposable inserter, which enables a “no touch” surgical procedure, because the substitute already fills the cage. The disposable inserter has a built-in depth stop, which helps provide a more secure way to perform the surgery.
• St. Jude Medical Inc. earned the CE mark for its next-generation quadripolar device, the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D). Built upon the company’s first-to-market quadripolar pacing system, the Quadra Assura MP CRT-D features MultiPoint Pacing technology that reportedly enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy pacing to meet individual patient needs.
• Sorin Group has received the CE mark for its Reply 200 family of pacemakers featuring Sleep Apnea Monitoring. Sleep apnea is highly prevalent and vastly undiagnosed in pacemaker patients. It increases the mortality risk and the risk of common cardiovascular co-morbidities such as hypertension, atrial fibrillation and heart failure. Moreover, sleep apnea complicates the management of common cardiovascular co-morbidities. According to the company, the Reply 200 SR and DR pacemakers automatically screen patients for the risk of severe sleep apnea using a sensor that measures ventilation.
• Stentys SA won expanded indications under the CE mark for the Stenty self-apposing stent, which treats acute myocardial infarction. According to the company, the stent is engineered to solve the dilemma of artery diameter discrepancy. It has a flexible, self expanding design intended to take the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel. The expanded indications were earned on the basis of additional clinical evaluation and now includes specific patient subsets such as those with tapered, aneurysmatic, ectatic (dilated) or very large vessels or those with bypass grafts. Contraindications such as chronic total occlusions and left main bifurcations also have been lifted. These changes allow Stentys to commercialize its self-apposing stent in new market segments that represent approximately 10 percent of all percutaneous coronary interventions in Europe.
• Retina Implant AG was granted the CE mark for its Alpha IMS, a wireless subretinal implant technology. The technology, which has been in global clinical trials since 2005, is designed to restore useful vision in patients blinded by the degenerative eye condition retinitis pigmentosa. The device is a subretinal microchip consisting of a 3 x 3 mm microchip with 1,500 electrodes. According to Retina Implant, to date, 36 patients have received the Alpha IMS microchip. This is the first European regulatory certification for the company and the Alpha IMS device.
• Cormedix Inc. was granted the CE mark for Neutrolin, a catheter lock solution designed to prevent catheter-related bloodstream infections (CRBIs) in hemodialysis patients. Neutrolin comprises an anti-coagulant and broad-spectrum of antibacterial and antifungal combination, which is active against microbes of common nature and restricts biofilm formation. According to Cormedix, it helps in maintaining catheter patency by restricting thrombosis, thereby lessening the requirement for systemic antibiotics and extending the life of central venous catheters. CRBIs and inflammatory complications are considered to be main reasons of morbidity in final stage renal disease hemodialysis patients.
• Integra LifeSciences Holdings Corp. earned the CE mark for its Integra smart cervical solution, a device approved in the European Union for treating degenerative diseases of the cervical spine that require stabilization and fusion of two or more cervical vertebrae. Delivered sterile in a double-blister pack, Integra’s smart cervical solution combines a cervical cage with a synthetic bone substitute, according to the company. The implant is pre-filled and attached to a disposable inserter, which enables a “no touch” surgical procedure, because the substitute already fills the cage. The disposable inserter has a built-in depth stop, which helps provide a more secure way to perform the surgery.
• St. Jude Medical Inc. earned the CE mark for its next-generation quadripolar device, the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D). Built upon the company’s first-to-market quadripolar pacing system, the Quadra Assura MP CRT-D features MultiPoint Pacing technology that reportedly enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy pacing to meet individual patient needs.
• Sorin Group has received the CE mark for its Reply 200 family of pacemakers featuring Sleep Apnea Monitoring. Sleep apnea is highly prevalent and vastly undiagnosed in pacemaker patients. It increases the mortality risk and the risk of common cardiovascular co-morbidities such as hypertension, atrial fibrillation and heart failure. Moreover, sleep apnea complicates the management of common cardiovascular co-morbidities. According to the company, the Reply 200 SR and DR pacemakers automatically screen patients for the risk of severe sleep apnea using a sensor that measures ventilation.