OrthoSensor™ has announced plans to launch its Verasense™ Knee System in European markets after recently receiving CE Mark approval. Verasense is the first integrated intelligent orthopaedic device to provide surgeons with real-time quantitative data on knee implant positioning, limb alignment and soft tissue balance during total knee replacement surgery.
Approval/Clearance
CE Mark and EU Launch of Medtronic’s New Compact CORNERSTONE-SR® Alliance™ Cervical Cage
Medtronic, Inc., a world leading spinal technology company, has taken the opportunity presented by two big spinal congresses to announce the CE marking and European launch of a new cervical cage system which expands the successful Compact CORNERSTONE-SR® platform of cages.
CE Mark for DFINE’s STAR™ Tumor Ablation System
Californian spinal technology company DFINE, Inc., has now received CE Mark approval for its STAR™ Tumor Ablation System for treatment of painful metastatic spinal tumors. The company officially launched the system in Europe at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress last month.
FDA Nod for Biotronik’s Ilesto ICD/CRT-D devices
Heart rhythm and home monitoring specialist Biotronik, has gained FDA approval for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D) devices.
First U.S. Patient for NeoTract’s UroLift® System
Following the announcement of the FDA clearance of NeoTract’s UroLift® System for treating symptoms of benign prostatic hyperplasia, the company has issued a press release confirming that a first patient has now undergone treatment with the device.
FDA Clears Vertebral Technologies’ Less Invasive Lumbar Fusion System
It’s a clever concept, the idea that by doing some assembly at the surgical site the physician can avoid large incisions. Vertebral Technologies’ newly FDA cleared system permits a large lumbar interbody fusion using a minimally invasive approach.
Medtronic’s Complete ‘SE’ Vascular Stent sees FDA Expand Indications Down the Leg
Peripheral Vascular Stent options in the US now include Medtronic’s Complete SE offering which has seen its indication extended to include the superficial femoral and proximal popliteal vessels.
Japanese Approval for Given Imaging’s PillCam® SB3
Small bowel disease, including Crohn’s, is now within the diagnostic grasp of Gastrointestinal physicians in Japan with the news that Given Imaging’s optimised SB3 PillCam has been approved for market release. Sales will start in 2014.
Sapien THV gets “Access all Areas” Nod from FDA
Edwards Lifesciences’ FDA approval for its Sapien Transcatheter Heart Valve was originally limited to transfemoral or transapical access. Now the access point restriction has been lifted, based on clinical registry data. Whether this opens up the patient population remains to be seen.
Relief All Round as FDA Clears NeoTract’s UroLift® Prostate Implant
NeoTract, Inc., has received De Novo approval from the U.S. FDA to market the novel UroLift® System, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with Benign Prostatic Hyperplasia, also known as enlarged prostate.
Vital Access Corp Announces FDA Clearance Of VWING™ Vascular Needle Guide
Vital Access Corp. has received U.S. FDA market clearance for its patented VWING™ Vascular Needle Guide which has been shown to enable vascular access to arteriovenous fistulas for patients undergoing hemodialysis.
CE Mark for JenaValve TAVI System Extended to Cover Aortic Insufficiency
JenaValve’s eponymous TAVI system has seen its CE mark indications extended, making it the only transcatheter valve system approved for the treatment of aortic stenosis and aortic insufficiency.
CE Mark for TyPEEK™ Means Spinal Device OEM Opportunities
Ortho/Spine device company Tyber Medical has gained CE Mark approval for TyPEEK, a proprietary titanium plasma sprayed PEEK interbody system. TyPEEK interbody fusion devices are specifically designed for situations where PEEK alone may not provide the best setting for fusion. Tyber Medical is a supplier of private label implants.
First for Gore as FDA Approves Prosthesis for Endovascular Repair of Aortic Dissection
W. L. Gore & Associates has gained FDA approval for its Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. This durable endoprosthesis is the only device to receive FDA approval for this indication and is designed for multiple thoracic etiologies.
FDA Clears Syneron Medical’s New VelaShape® III Platform for Abdominal Circumferential Reduction…CE Mark Too!
Aesthetic medical device company Syneron Medical Ltd., has announced FDA clearance and CE mark approval for VelaShape® III, the Company’s new non-invasive body shaping platform. This new platform is said to be effective for temporary reduction in circumference of the abdomen and is also used in a wide range of other body shaping applications such as cellulite treatments.
CE Mark for Keystone Heart’s TriGuard™ Cerebral Protection Device
Keystone Heart’s clever filter sits over the aortic cerebral branches during TAVR and other interventional heart procedures, preventing debris from heading north. Now the device, developed in Israel, has gained CE marking and will now be introduced into Europe.