Newly cleared AHBP is ready-to-use and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery.
Approval/Clearance
Newly CE Marked Stent Offers Drug Protection After Polymer Coating Has Gone.
Micell’s MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System is a thin-strut stent that features elimination of the coating from the stent in 45-60 days and the complete absorption of the polymer coating within 90 days. Uniquely it provides local drug delivery both during and after the period of polymer absorption, thereby eliminating long-term polymer exposure, a potential cause of delayed healing and late adverse events.
FDA Approval For St. Jude’s Ellipse™ and Assura™ ICD/CRT-Ds
Last month St. Jude Medical, Inc. told us it had gained CE mark approval for its next-generation Ellipse™ and SJM … continue reading “FDA Approval For St. Jude’s Ellipse™ and Assura™ ICD/CRT-Ds”
Trial Will Test SurgiMend® PRS Breast Cancer Reconstruction Claims
TEI Biosciences, Inc. has gained FDA Investigational Device Exemption (IDE) approval to initiate a human clinical trial to gain specific … continue reading “Trial Will Test SurgiMend® PRS Breast Cancer Reconstruction Claims”
CE Mark For CryoLife’s New HeRo® Graft
Tissue processing and device company CryoLife, Inc.,has gained a CE Mark for its new iteration HeRO (Hemodialysis Reliable Outflow) Graft … continue reading “CE Mark For CryoLife’s New HeRo® Graft”
FDA Clears Body-Worn ECG Monitor
Cardiac arrhythmia specialist company, Cardiac Insight, Inc., has received US FDA 510(k) clearance for its Stealth™ body-worn ECG monitor
FDA Clears GE Healthcare’s Brivo Plus imaging C-arm
GE Healthcare has gained FDA 510(k) clearance for its latest Brivo Plus C-arm, which is now available in the US. The pitch for the newly cleared device is that with legacy OEC image quality and ease-of-use, the affordability and reliability of this new Brivo C-arm will offer a high quality, economically attractive option for basic surgical imaging.
FDA Clears Cook’s Evolution® Biliary Controlled-Release Uncovered Stent
Cook Medical has received FDA 510(k) clearance for its Evolution® Biliary Controlled-Release Uncovered Stent. The company says its device is the … continue reading “FDA Clears Cook’s Evolution® Biliary Controlled-Release Uncovered Stent”
FDA Clearance and CE Mark For Medtronic’s New Peripheral Angioplasty Balloon
Peripheral Vascular Disease therapies include the use of percutaneous transluminal angioplasty(PTA) using a balloon catheter. While recent news has been all about the race to (U.S.) market for drug eluting varieties, Medtronic is no doubt hoping its Pacific Plus device is sufficiently feature-packed to take a chunk of the market until their drug eluter gains approval.
CE Mark For ArtVentive’s Endoluminal Occlusion Device
ArtVentive Medical Group, Inc. has received European CE Mark certification for the ArtVentive EOS™ Peripheral Vascular Endoluminal Occlusion system. The company is very coy about sharing its IP, to the extent that we’re not really sure how it works. But studies suggest it’s 100% effective, which is good enough for the CE brigade.
FDA Clearance Gives Hope Of Better Rehab For Stroke And Spinal Cord Injury Patients
The FDA has granted 510(k) clearance to a muscle and joint rehabilitation medical device that tricks the brain into re-establishing communication with muscles affected by brain or spinal cord damage.
Medtronic’s Endurant II AAA Stent Graft System First To Only Require Uni-Iliac Access
Medtronic, Inc. is showcasing its newly approved stent graft at this weekend’s Vascular Annual Meeting, taking place in San Francisco. The company has gained FDA approval for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA 510(k) clearance for the Sentrant Introducer Sheath
CE Mark And EU Launch For Sequent Medical’s New SL Family of Web Aneurysm Embolization Devices
Sequent Medical, Inc. has gained the CE mark for the SL (“Single Layer”) family of WEB® Aneurysm Embolization Devices, and … continue reading “CE Mark And EU Launch For Sequent Medical’s New SL Family of Web Aneurysm Embolization Devices”
FDA 510(k) Clears iTraumaCare™ iTClamp™ Hemorrhage Control System
Medical Device Firm iTraumaCareTM Receives FDA 510(k) Clearance for iTClampTM Hemorrhage Control System
CE Mark For Boston Scientific’s GUIDE™ DBS System
Boston Scientific Corporation has gained CE Mark approval for use of the GUIDE™ DBS System, the world’s first deep brain … continue reading “CE Mark For Boston Scientific’s GUIDE™ DBS System”
Hill-Rom Receives FDA 510(k) Clearance to Market MetaNeb 4.0 Airway Clearance System
Hill-Rom Holdings, Inc. has received 510(k) clearance from the U.S. FDA to market the MetaNeb® 4.0 airway clearance system. The system helps enhance normal mucus clearance from the lungs, delivers lung expansion therapy, and assists in the treatment and prevention of pulmonary atelectasis, a complete or partial collapse of the lung.