J&J’s Cordis subsidiary has seen results presented on its S.M.A.R.T peripheral vascular stent, which show durable 80% patency figures and improved patient outcomes.
Vascular
Argon Medical Devices Launches Cleaner15™ Rotational Thrombectomy System
End Stage Renal Disease specialist, Argon Medical Devices, Inc. has launched the Cleaner15™ Rotational Thrombectomy System, providing physicians with another weapon in their arsenal to safely and effectively restore patency in occluded arteriovenous fistulae and synthetic grafts.
Covidien Joins Renal Denervation Party With OneShot™ Launch
Covidien has announced the commercial launch of the OneShot™ Renal Denervation System, an over the wire balloon-based irrigated catheter technology for the treatment of high blood pressure or hypertension.
FDA Approval for New GORE® EXCLUDER® AAA Endoprosthesis Component
Gore has received FDA approval to extend its AAA range to include a new large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender components, as well as the lower profile 31 mm diameter trunk-ipsilateral leg and 32 mm aortic extender components of the GORE® EXCLUDER® AAA Endoprosthesis.
New Study Will Establish Place For Mechanical Thrombectomy In Acute Ischemic Stroke
The first patient has been recruited to a new clinical trial, which represents one of the largest global studies to examine the effectiveness of an advanced mechanical treatment in stroke care.
St.Jude’s Earnings Hold Up As Cost Savings Kick In
St. Jude Medical, Inc. revenues for the quarter just ended again showed a decline compared with the equivalent period a year ago, although the drop-off was overall slightly less marked than it had been in Q3. And the bottom line held up as cost saving measures played out.
Abbott Initiates U.S. Mega Study On Absorb™ Stent
Abbott’s newly announced Absorb™ absorbable stent trial is unquestionably huge, the number probably driven by the quest for significant results and the additional study end points identified in the protocol. Data from the ABSORB III trial will support U.S. regulatory filings for the device.
Five Year Results From ClosureFast™ Study Show Durable Treatment Success In CVI Patients
Covidien is trumpeting the five-year results of its ClosureFast™ Long-Term European Multi-Centre Study in patients with Chronic Venous Insufficiency. 92% of patients still had effective occlusion of target vessels after five years, supporting the claim that the treatment is durable in the longer term.
Covidien To Acquire Drug Coated Balloon Company CV Ingenuity
Covidien has announced a definitive agreement to acquire CV Ingenuity. The companies expect to complete the acquisition in the first calendar quarter of 2013.
Who Owns Renal Denervation?
Renal Denervation: If you’ve not heard the phrase before, get used to it, because the therapy has so many potentially interesting applications with very promising outcomes thus far, it’ll soon be mainstream. A new article ponders the complicated intellectual property position.
Merit Medical Snare’s FDA Clearance
Merit Medical, Inc., has a new FDA 510(k) clearance to trumpet: Merit’s ONE Snare™ endovascular snare system will see its U.S. launch in January
Postmarketing Data Pours A Bit Of Cold Water Down Covidien’s Pipeline
Covidien’s eV3 subsidiary business brought with it the Pipeline embolisation device when it was acquired. While the device shows encouraging results in patients with certain types of difficult-to-treat brain aneurysms, a new report suggests there are also reasons for some caution over fatal bleeds.
CE Mark For Range Extensions To Gore’s Excluder AAA Endoprosthesis
W.L. Gore has gained CE Mark for the new large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender components of the Gore® Excluder® AAA Endoprosthesis expanding the overall treatment range to 19-32 mm.
Presence of Particulates Provokes Pre-filled Isovue® Syringe Recall
U.S. device company Bracco Diagnostics has issued a voluntary Class I recall of its Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes. It seems particles have been found in certain lots, with the obvious concern about stroke risk should any of these find there way into the cerebral vasculature.
Cordis Incraft™ AAA Stent Graft Promising 1 Year Clinicals
J&J subsidiary, Cordis has seen its Incraft AAA stent graft study results reach 1 year with no problems and 100% efficacy. The graft, with its 13Fr delivery system aims to extend EVAR To More Patients than currently indicated.
CE Mark For No-Option Critical Limb Ischemia Bone Marrow Aspiration Therapy
CE mark for Harvest Technologies’ Bone Marrow Aspiration system means that, for the first time, European critical limb ischemia patients, at severe risk of amputation, now have a treatment option.