Cardiovascular device specialist ReFlow Medical Inc. has gained CE mark approval for its Wingman35 Crossing Catheter and speX™ Shapeable Support Catheter.
Approval/Clearance
Covidien Expands US Sonicision™ Range Following FDA Clearance
Covidien plc says its Sonicision™ Cordless Ultrasonic Dissection Device portfolio extends to 13 cm, 26 cm, and 48 cm device lengths following U.S. FDA 510(k) clearance.
CE Mark for Non-Invasive Open Ventilation (NIOV) System
Breathe Technologies’ NIOV device has become the first and only wearable, ventilation system for people with respiratory insufficiency to receive a CE Mark.
CE Mark and First US Implant for Medtronic’s Re-Sheathable CoreValve
Medtronic has gained CE Mark approval for the 23 mm CoreValve® Evolut™ R TAVI System and has seen the device’s first implantation in its U.S. study.
Codman Neuro’s REVIVE™ SE Thrombectomy Device Approved in China, South Korea and Taiwan
J&J’s Codman Neuro has gained a clutch of Far Eastern regulatory approvals for its REVIVE™ SE Thrombectomy Device for restoring blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease.
510(k) Clearance & CE Mark for K2M’s MESA Hooks for Complex Spine Procedures
K2M Group Holdings, Inc., newly in public hands, has received U.S. FDA 510(k) clearance for their MESA Hooks. The company has also received the CE Mark for the product, the latest implant addition to the MESA® Deformity Spinal System.
FDA Clears Medtronic SHILLA™ Growth Guidance System
Medtronic has gained U.S. FDA 510(k) clearance for its SHILLA™ Growth Guidance System, designed to treat spinal deformities in skeletally immature pediatric patients with severe, progressive, life-threatening, early-onset spinal deformities.
FDA 510(k) Clearance for CardiacAssist’s PROTEK Duo™ Veno-Venous Cannula
Newly cleared PROTEK Duo™ veno-venous cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
FDA Clears CorMatrix® CanGaroo™ ECM® Envelope for Cardiac Implantables
Cormatrix’s aptly named CanGaroo envelope (or pouch) offers a marsupialised approach to cardiac device implantation.
FDA Approval for Medtronic Viva® Cardiac Resynchronization Therapy-Pacemaker
CE marked earlier in the year, Medtronic’s Viva CRT-P system will now be available for US patients following its newly announced FDA approval.
CE Mark for New Size of Direct Flow Transcatheter Valve Plus No Use of Contrast Media
This is big news for Direct Flow as it needed that 23mm option to open up a new patient cohort. The avoidance of contrast media is big for the company too.
FDA Clears Premvia™ Hydrogel Scaffold for Regenerative Indications
BioTime, Inc. says its Premvia™ hydrogel tissue substitute has been cleared for marketing as a Class II medical device.
FDA Approval for Medtronic Attain Performa® Quadripolar Lead and Viva® Quad CRT-Ds
Medtronic’s new Performa® Quadripolar Lead and Viva® Quad CRT-Ds claims optimal and efficient Cardiac Resynchronization Therapy
FDA Approves SynCardia’s Total Artificial Heart With SynHall Valves
FDA approval for SynCardia temporary Total Artificial Heart with SynHall valves, gives the company control over the last key component to manufacture the Total Artificial Heart.
FDA Nod for Medicrea K-JAWS® Cervical Fixation Staple
Medicrea says its K-Jaws spinal cervical compression staple offers a less invasive and quicker solution than cervical fixation option.
Complex Spine and MIS Line Extensions & Regulatory Clearances for K2M
K2M has gained U.S. marketing clearance for its CASPIAN® Occipital Anchor Spinal System and has also announced other product introductions across the globe.