Gore’s Tigris Vascular Stent Approved
Gore has received premarket approval from the FDA for its Tigris vascular stent.
The device features a combination of flexible fluoropolymer and single-wire nitinol and is designed to adapt to the natural movement of the knee. Study data on the product showed a 0 percent rate of fractures versus 27 percent on the control arm.
Alcon’s Cypass System Approved
The FDA approved Alcon Laboratories’ CyPass System – a tiny stent implanted into the eye to drain fluid in patients with glaucoma.
The CyPass System consists of a micro stent that is pre-loaded into a stent-delivery tool. The stent is designed to control intraocular pressure (IOP) by creating a drainage pathway from the anterior chamber to the outermost layer of the eye.
Clinical trials in 374 patients implanted with the device saw 72.5 percent achieve IOP compared to 58 percent who received cataract surgery alone.
510(k) Clearance for Hydrocodone Assay
The FDA granted 510(k) clearance for Thermo Fisher Scientific’s immunoassay for detecting hydrocodone.
The DRI Hydrocodone Assay is a homogeneous enzyme immunoassay featuring requisite sensitivities that meet the newly proposed Substance Abuse and Mental Health Administration guidelines using a 300 ng/mL cut-off.
The DRI Hydrocodone Assay is reactive to the major metabolites hydromorphone and hydromorphone-glucuronide and uses liquid, ready-to-use reagents, which can be run in both qualitative and semi-quantitative modes.
Boston Scientific Recalls Lotus Valves
Boston Scientific has issued a recall for Lotus valve devices with issues with release mandrel breakage.
The release mandrel is a delivery system component connected to the release pin.
The company said it has received numerous reports of catastrophic vessel trauma associated with damaged versions, including three reported patient deaths.
BTG’s DC Beads Now Class III Devices
DC Bead and DC Bead M1 have been reclassified as Class III medical devices.
These devices are embolic drug-eluting beads capable of loading and releasing compatible chemotherapeutic agents.
These drug administrators are the only drug-eluting beads with CE Mark approval for filling with doxorubicin and irinotecan.
FDA Grants Market Clearance for Permaseal
Micro Interventional Devices received FDA clearance for the company’s first product, a transapical access and closure device.
The Permaseal device allows surgeons to access and close the left-ventricle without suturing the myocardium.
Clinical trials indicated that the device shortened operating time and hospitalization.