Using a Drug-coated balloon to implant a bare metal stent might just be a smart idea, at least according to Dutch Cardiovascular specialists Blue Medical in announcing the launch of their innovative new offering.
Approval/Clearance
CareFusion’s New Electrodiagnostic System Gains FDA Clearance
Carefusion’s Viking on Nicolet® EDX Electrodiagnostic system has gained FDA clearance and will be shown at forthcoming America Academy of Neurology meeting in New Orleans.
Canada Approves Medtronic’s DBS For Epilepsy And Boston’s Cardiac Ablation System
Two new device approvals announced for Canada this week. Neither Medtronic’s DBS therapies for epilepsy nor Boston Scientific’s RF ablation catheter are US FDA approved, but Health Canada are clearly convinced by the weight of the submissions.
Everflex: FDA Releases Summary Documents
FDA has now released summary information relating to last week’s newly US-cleared Everflex peripheral vascular stent from Covidien.
Landmark FDA Clearance For GINTUIT™ Oral Soft Tissue Regeneration Sheet
FDA Approval for Organogenesis Inc’s Gintuit™ marks first cell-based product for use in dental market.
FDA Clearance For Covidien’s Everflex™ Long Peripheral Stent
Covidien’s past acquisitions keep coming up trumps. EV3’s Everflex™ device has now been cleared for US marketing by FDA, bringing a useful new long stent option to peripheral vascular surgeons.
Baxano’s iO-Flex® Spinal Decompression System Gains CE Mark
Baxano’s iO-Flex® Spinal Decompression System is heading to Europe with CE mark approval following its earlier FDA clearance.
Abbott’s Absolute Pro® Vascular Stent Receives FDA Approval For Iliac Artery Disease
Abbott’s Absolute Pro Stent for Iliac Disease has gained FDA clearance. The product is designed for precise stent placement and Optimal Flexibility to Conform to Challenging Lesions.
CE mark For Medtronic’s Next Generation MRI-Friendly Pacing Lead
Medtronic raises the bar in MRI compatible pacing leads with CE mark for its new small diameter offering.
FDA Issues Guidance On TriVascular Ovation EndoGraft For Patients With Small Access Vessels And Small Aortic Anatomy
After granting approval for TriVascular to sell its Ovation Endograft in USA under Humanitarian Exemption, FDA now issues guidance for consumers.
K2M’s SANTORINI™ Corpectomy Cage Systems Gain FDA Clearance
K2M Inc has announced the FDA 510(k) clearance of its Santorini Corpectomy Cage System, adding to the company’s portfolio of offerings for treatment of complex spine disorders.
CE Mark For Checkpoint® Neuroprotective Stimulator Device
Checkpoint’s newly CE marked device helps surgeons avoid nerve damage.
FDA Clears Covidien’s Solitaire™ FR Revascularisation Device
With a certain inevitability following rave reviews in its pivotal clinical study, Covidien’s revascularisation device for removing clots from occluded vessels in stroke patients has now gained FDA 510(k) clearance.
Cappella’s Sideguard® Coronary Stent Now Approved In India
How to stent a sidebranch. Cappella knows how and has now supplemented CE mark for its Sideguard® system with Indian approval.
Double Whammy For Cook With First Japanese Drug-Eluting Peripheral Stent And First Stent For SFA Indication
Cook’s Zilver PTX Becomes First SFA Stent and first Drug-Eluting Peripheral Stent
New Steerable Balloon Vertebral Augmentation Device Gains CE Mark
CE mark for clever Steerable Balloon from Osseon, which it claims challenges existing kyphoplasty systems.