Claret Medical has gained CE mark approval for its Montage 2™ which becomes the only approved filter system protecting the carotid arteries capturing embolic debris during intravascular procedures such as Transcatheter Aortic Valve Repair.
Approval/Clearance
FDA Clearance For Surgery Rehearsal Platform™
Surgical Theater, LLC™, has received FDA clearance for its Selman Surgery Rehearsal Platform™(SRP), making it the only patented and FDA cleared platform for cerebral and spine pre-surgery rehearsal in the marketplace. And its clever stuff, using standard scanned images from the patient, the SRP generates 3D patient specific and accurate models showing the interaction between life-like tissue and surgical instruments.
Medtronic Gains First FDA Approval Under New Early Feasibility Study Rules
Medtronic’s new Transcatheter pulmonary valve study, approved by the FDA, represents the first time this new draft guidance has been employed. The result should be a better product, earlier to market, if the klegislation is doing its job.
FDA Clears New Sizes Of Resolute Integrity Coronary Stent For Long Lesions Common Among Diabetes Patients
Medtronic, Inc. has announced that the U.S. FDA has approved the 34mm and 38mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm. The longer lengths include an indication for patients with diabetes in whom longer lesions are common.
CE Mark For NxStage Single Needle for Dialysis Patients
Last week we wrote about NxStage® and its new CE approval for its System One dialysis machine. Now the company has announced that its single needle technology, OneSite™, has received CE Mark approval.
FDA Approves First Single-Lead ICD with Atrial Sensing
Biotronik has announced the FDA approval of its Lumax 740 DX System. This novel device is a first-in-class implantable cardiac defibrillator (ICD) that utilizes a single lead with atrial sensing capabilities.
NxStage Announces CE Mark Approval for New High Flow Capabilities with System One
Dialysis product company NxStage® Medical, Inc. has announced CE Mark approval for new high flow capabilities with the NxStage System One™. With this approval, the Company expects to bring this advancement to customers in countries that recognize the CE Mark approval process later this year.
Europe’s Most Popular Breast Implant Gets FDA Nod
Allergan’s Natrelle® breast implant line now extends to a newly FDA approved shaped silicone gel option. The implant is already available in Europe and has proven popular, not least because of its anatomical shape.
FDA Clears Dallen Medical’s New Compressyn™ Staple For Rigid Small-Bone Fixation
Dallen Medical has received FDA 510(k) clearance for the Compressyn™ Staple for small bone fixation, specifically in foot, ankle, and hand applications. The company says its patented technology offers significant improvement over existing products when it comes to fixation and dynamic compression.
Small, MRI Compatible And With Remote Monitoring: What’s Not To Like About Biotronik’s Newly CE Marked Ilesto 7 ICD/CRT-D Devices?
Biotronik has announced that its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series has received CE approval. The device family includes the one of the world’s smallest ICDs and is MRI compatible as well as being equipped with Biotronik Home Monitoring® technology.
FDA Approval For “Bionic Eye”
Second Sight Medical’s Argus® II Retinal Prosthesis System is the first approved bionic eye in the US with life-changing potential for the treatment of blindness due to retinitis pigmentosa
FDA Approval Of Aorfix AAA Graft Opens Treatment For Patients With Neck Angulation Of Up To 90 Degrees
Lombard Medical Technologies PLC has announced that its Aorfix™ endovascular stent graft has been approved for commercial sale in the U.S. by the FDA. Aorfix™ is now the only endovascular stent graft licensed in the U.S. for use in more challenging cases with neck angulations greater than 60 degrees.
CE Mark For ApiFix’s Ingenious Yet Simple Scoliosis System
What an elegant system this is. ApiFix’s newly CE marked device minimises surgical trauma for scoliosis correction in adolescents, and then works in combination with physiotherapy to incrementally correct a curvature over time. Quite a brilliant idea.
FDA 510(k) Clearance for Freedom Meditech’s ClearPath DS-120™ Ophthalmic Biomicroscope
Freedom Meditech’s clever lens-fluorescence biomicroscope is a non-invasive ophthalmic diagnostic device that obvates the need for dilation drops and claims greater precision than current standard of care devices.
CE-mark And Launch Of CERAMENT™|G The First Injectable Gentamicin Eluting Bone Substitute To Promote And Protect Bone Healing In Osteomyelitis
Scandinavian medtech company Bonesupport is an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery. The company has announced that the next generation product of the CERAMENT™ family, CERAMENT™|G has received CE-mark.
FDA Nod For Medtronic’s New MRI-Friendly Pacing System
Medtronic has gained FDA approval and will commence U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The system is Medtronic’s second-generation MR-Conditional pacemaker and is the first to combine the most advanced pacing technology with proven MRI access.