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.
Products
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.
Europe-wide Release for Biotronik’s Passeo-18 Lux Peripheral Vascular Drug-Releasing Balloon
Cardiovascular device company Biotronik is in the news again with the announcement of its release of the Passeo-18 Lux Drug Releasing Balloon (DRB) in all countries accepting CE mark, following recent CE approval.
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.
FDA 510(k) Clearance for Varian’s ProBeam™ Proton Therapy System
Varian Medical Systems has received FDA 510(k) clearance for its updated ProBeam™ proton therapy system which the company claims minimizes proton therapy dose to healthy tissues that surround cancers.
New Screw System Improves on K-Wires in Scapholunate Instability
Acumed has issued a press release trumpeting its new so-called SLIC Screw System for wrist reconstruction, which it says offers surgeons a new adjunct to soft tissue repair or reconstruction as it holds the bones in their reduced state while soft tissue repair heals.
MediValve’s acWire™ Guidewire Gains 510(k) Clearance and CE Mark
Israeli device company MediValve has announced the FDA clearance and CE mark approval of its acWire™ Guidewire, intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices.
Green Light for U.S. Trial of SAPIEN 3 Valve for Intermediate Risk Patients
Edwards Lifesciences’ new U.S. trial of the SAPIEN 3 valve will enroll up to 1,000 patients with a Society of Thoracic Surgeons score of four to eight percent, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a SAPIEN 3 valve.
New CE Mark for Stem Cell Catheter Means Transendocardial Therapy in Larger, Dilated Hearts
So-called transendocardial delivery of stem cells has solid clinical evidence supporting it. And now it has a newly CE marked catheter that opens up the procedure to patients with enlarged, dilated hearts, widening the pool of patients who can benefit from the therapy.
Full Steam Ahead for Direct Flow Medical® with CE Mark for 29mm Valve and Full Enrollment in US Feasibility Study
TAVI developer Direct Flow Medical®, Inc., has received CE Mark for the first fully repositionable 29mm transcatheter aortic heart valve in the same week that the company has announced completion of enrollment in its US feasibility trial in patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement.
Contact-Free Bedside Patient Monitoring Extended with New FDA Clearance
As financial pressures mount, automated bedside patient monitoring should really provide reassurance that patient care won’t drop through the cracks. New enhancements to the EarlySense system deliver more monitoring options, including respiration, heart rate and motion.
Spine: FDA Clears K2M’s Cayman® Minimally Invasive Single Level Lateral Plate
K2M, Inc., has received 510(k) clearance from the US FDA to market CAYMAN® Minimally Invasive, the latest addition to the company’s CAYMAN product family of plate systems already featuring CAYMAN Anterior, CAYMAN Buttress and CAYMAN Lateral .
Newly FDA Cleared SinuSys™ Vent-Os™ Sinus Dilation System Simplifies In-Office Treatment of Sinusitis
Sinus Health company SinuSys™ Corporation has announced the FDA clearance for its Vent-Os™ Sinus Dilation System, which it will start to commercialize immediately in select markets in the U.S.