Stryker’s Wingspan Stent is up for FDA panel review on March 23rd. FDA’s Executive Summary, released today doesn’t auger well as results of clinical study don’t seem to support safety and efficacy claims.
Clinical Studies/Trials
Cook’s Zilver® PTX™Peripheral Stent Gains Australian Approval
Vascular Surgeons in Australia now have access to a new technology, with the approval of Cook Medical’s Zilver PTX drug-eluting stent for treatment of peripheral artery disease.
Blue Medical Trumpets New Drug-Eluting Balloon/Stent Combination
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.
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.
First Patient Enrolled In European Deep Brain Stimulation Registry For Refractory Epilepsy
Deep Brain Stimulation for Refractory Epilepsy: First patient enrolled in Netherlands some 25 years after DBS was first indicated for essential tremor.
Drug Coated Balloon Effective In Drug-Eluting Stent Restenosis
A new clinical trial investigated the treatment of restenosis in a drug-eluting stent (DES) using a drug-eluting balloon. Results are significantly better than those achieved with uncoated balloon.
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.
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.
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.
AtriClip Stroke Safety and Feasibility Trial Gains FDA Approval
AtriCure has gained FDA’s blessing to commence a study into the impact of its AtriClip Left Atrial Appendage exclusion device on stroke prevention.
Teleconsultation Avoids Referral In 74% Of Dermatology Cases
A great study in “teledermatology” supports a new approach to GP consultation by involving the specialist dermatologist much more close to the front line. Referrals were reduced dramatically.
Stents vs Medical Therapy: 7000 CAD Pt Meta-Analysis Shows No Significant Difference.
A new publication casts doubt on stenting of stable coronary artery disease patients as a supportable first treatment.
Retrospective Data Analysis Suggests Clinical and Economic Advantages Of VATS vs Open Wedge Resection
Ethicon-Endo-supported retrospective data study says VATS is cheaper and better than open wedge resection.
Shock Wave Therapy Wound Treatment Works
Can CellSonic make its ESWT offering a world beater in treating troublesome non-healing wounds?
Available In EU Since 2004, First US Implant Of Sorin’s Stentless Pericardial Aortic Valve
Eight years after first European implantation Sorin’s Freedom Solo stentless pericardial aortic valve sees its first US patient.
Bradford Adopts Heartscape Vest To Diagnose Heart Attacks
UK’s Bradford Royal Infirmary has embarked on a much-publicised evaluation of Verathon’s Heartscape Vest in the hope that it will fulfill its promise of achieving early and efficient diagnosis of heart conditions including heart attack.