Medtronic Inc. (NYSE:MDT) landed FDA clearance for its DF4 high-voltage right ventricular lead for use with implantable cardiac rhythm management devices.
The DF4, which builds on Medtronic’s Sprint Quattro lead, aims to help simplify the implantation process with a redesigned port and by providing visual confirmation of the lead’s connection to the device.
"Medtronic is bringing U.S. physicians the reliability of the Quattro lead, which has 10 years of proven performance, along with the newest innovation in connection systems," cardiac rhythm disease president and senior VP Pat Mackin said in prepared remarks. "It’s a lead tested by time, coupled with the latest technological advancements."
The Quattro device has a single set-screw to connect to the lead to a device, where traditional high-voltage connector systems require up to three connections, according to a press release.
The new lead will work with several Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, including the company’s Protecta, Consulta and Secura lines.
The Fridley, Minn.-based med-tech titan has had a lot of regulatory news this month, including closing enrollment for the “extreme-risk” population of its CoreValve transcatheter aortic valve implantation study, initial patient enrollment in its Fire & Ice cardiac ablation study and CE Mark approval and commercial launch of the Endurant II stent graft in the European Union.
Cynosure lands FDA OK for cellulite laser device
Cynosure Inc. (NSDQ:CYNO) won FDA 510(k) clearance for its Cellulaze cellulite laser workstation, a minimally invasive device that directly treats the physiological structure of cellulite. Read more
Covidien wins IDE approval for stroke management system study
Covidien plc (NYSE:COV) won investigational device exemption for the FR revascularization device for use in the Interventional Management of Stroke (IMS III) trial. Read more
Baxter touts expanded indication for Tisseel
Baxter International Inc. (NYSE: BAX) won FDA extended clearance for the Tisseel system to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical. Tisseel mimics the final stages of the body’s own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis. Read more
Systagenix announces CE Mark for WoundChek
Systagenix Wound Management won CE Mark approval in the European Union for its WoundChek protease status, which it calls the world’s first rapid, point-of-care diagnostic test developed specifically for chronic wounds. Read more
Trans1 confirms Hawaiian reimbursement for AxiaLIF fusion
TranS1 Inc. (NSDQ:TSON) won reimbursement confirmation for its AxiaLIF spinal fusion procedure from the Hawaii Medical Service Assn., the Blue Cross & Blue Shield provider for Hawaii. Read more
Positron subsidiary wins Strontium-82 license amendment
Positron Corp. (OTC:POSC) said its subsidiary Manhattan Isotope Technology won approval of its radioactive materials license amendment from the Texas Dept. of State Health Services-Radiation Control Program. Read more
Applied Spectral Imaging lands FDA clearance for SpotScan
Applied Spectral Imaging announced today ASI’s GenASIs Scan & Analysis, SpotScan used for the detection of chromosomal aberrations in bladder cancer has been cleared by the FDA for marketing in the US. Read more
CardioKinetix wins Euro approval for 2 more Parachute sizes
CardioKinetix Inc. announced CE Mark approval for 2 additional sizes of its Parachute ventricular partitioning device. Read more
VuComp wins PMA for computer-aided mammogram reading
VuComp Inc. won FDA pre-market approval for its M-Vu algorithm engine, a computer-aided detection software device intended to help radiologists read routine screening mammograms. Read more
Charter Medical wins CE Mark for stem cell storage containers
Charter Medical won CE Mark for its next-generation cryogenic stem cell storage containers, designed for storage, preservation and transfer of hematopoietic progenitor cells. Read more