With total joint implants, one tiny mistake can have significant consequences. In this case no patient injury has been reported, but labelling within the Mathys balanSys Knee system incorrectly matches tibial and femoral components, with the risk of subsequent instability and pain. The company has issued a field safety notice.
Regulatory
FDA Clearance for Nidek CEM-530 Specular Microscope
The U.S. FDA has issued 510(k) Clearance for Nidek’s revolutionary new CEM-530 Specular Microscope that acquires images of the corneal endothelium and provides analysis very quickly and easily.
MedShape Unveils ExoShape Femoral Soft Tissue Fastener
Ideas like this have been mooted for many years: An ACL femoral fixation implant that doesn’t need to be screwed in, yet retains firm graft/tunnel apposition. MedShape makes the most of its proprietary memory shape PEEK Altera material to form what it hopes is the perfect solution.
Medtronic’s Valiant Captivia Stent Graft Now FDA Approved for Aortic Dissections
Medtronic has taken the opportunity presented by this weeks Thoracic Society meeting to announce that it has gained U.S. FDA approval for its Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections.
FDA Clears AtheroMed’s Phoenix Atherectomy System® for Treating Peripheral Artery Disease
AtheroMed has announced the FDA’s clearance to market the Phoenix Atherectomy System, which allows physicians to treat PAD with a low profile atherectomy catheter that continuously removes diseased material as it is debulked and does not require specialized capital equipment.
FDA filing for eNeura’s SpringTMS® Migraine Treatment
eNeura Inc., a privately held medical technology company, has announced the filing of a 510(k) with the U.S. FDA for the SpringTMS® transcranial magnetic stimulation (TMS) device, a progression from its already approved CerenaTMS solution for migraine treatment.
Newly Cleared KIVA® VCF Treatment System a Departure from Balloon Kyphoplasty
The Kiva® VCF Treatment System by Benvenue Medical, Inc. has received U.S. FDA 510(k) clearance for the reduction and treatment of spinal fractures. The company says its implant based system is the first departure from balloon kyphoplasty for a decade.
Can Ultrasound Rescue Renal Denervation? ReCor Says Yes
ReCor Medical’s Paradise Renal Denervation System uses ultrasound energy to do the job, compared with the RF used by its major competitors. In the wake of Symplicity HTN-3’s poor results, ReCor is keen to put some fresh air between its approach and that of the opposition, pointing to favourable outcomes in patients who had already been treated with RF energy.
Edwards Lifesciences Sapien 3 Heart Valve to Launch Imminently Following E.U. Approval
Edwards Lifesciences Corporation has received CE Mark approval for the SAPIEN 3 valve. European launch of what Edwards is calling its most advanced transcatheter aortic valve is imminent.
FDA OK’s Medtronic Pacemakers for Full-Body MRI Scans
Medtronic, Inc. has announced the U.S. FDA approval of its Medtronic SureScan® pacing systems that are compatible with use of MRI scanning on any region of the body.
IFU Changes Mean Codman Neuro’s TRUFILL® n-BCA Liquid Embolic System Gets Class I Recall Status
Codman Neuro has announced changes to the instructions for use for its TRUFILL® n-BCA Liquid Embolic System. It seems incorrectly mixed product can result in embolization or reflux, which has lead the U.S. FDA to label the company’s medical device correction notice as a Class I recall.
FDA Clears Orfit’s Nanor™ Technology for Patient Immobilisation During Radiation Therapy
The FDA has cleared Orfit’s thermoplastic technology for use in patient immobilisation during delivery of targeted radiation treatment. The new material means devices such as the Nanor Mask can be designed to deliver enhanced patient comfort, treatment precision and environmental benefits.
FDA Clearance for Covidien LigaSure™ Maryland Jaw
Covidien has received U.S. FDA 510(k) clearance for the LigaSure™ Maryland jaw open/laparoscopic sealer/divider. In addition the company has completed all European requirements to CE Mark the product. It expects to launch the new vessel sealer and divider in the United States and the European Union during the current quarter.
ReSure® Sealant Becomes First FDA Approved Corneal Incision Gel
Ocular Therapeutix’s ReSure Sealant has become the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults. Prior to this approval, stitches were the only option for closing a leaking corneal incision after cataract surgery in the United States
FDA Clearance Means OptionELITE IVC Filter Becomes First Over-The-Wire Retrievable System
Argon Medical Devices, Inc. says it has received FDA clearance to begin marketing its OptionELITE retrievable inferior vena cava filter with a new over-the-wire delivery technique. This new clearance enables physicians to safely deliver the filter to a patient’s IVC by following the path of a guidewire.
On-X® Mechanical Heart Valve Becomes First to Officially Need Lower Blood-Thinner Dose
New clinical data has been used to support a modification in the CE Mark labelling claims of the On-X® Life Technologies Inc. mechanical aortic valve, which means patients will require significantly lower doses of blood thinner than other mechanical heart valves.