Abbott has announced that the XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has gained CE Mark approval for the treatment of coronary artery disease. The company is launching the product immediately in CE Mark countries.
Stents
InspireMD Hints At Positive Results From MGuard™ Stent Trial
It’s a right old game isn’t it? Issue a press release when the study’s announced, another when enrollment’s complete, another suggesting the results are good (this one) and finally another when the results are published in October. And what does a “positive outcome” suggest? No worse? Marginally better? Much better? Stupendously better? Whatever, it’s a fine example of squeezing the PR pips out of a clinical study.
How Can Stryker’s Wingspan Neuro Stent Maintain Broad CE Mark In Europe When U.S Study Results Have Driven FDA To Restrict It’s Use?
The consequences of our distinct regulatory set-ups is that sometimes study information that drives indications for use one side of the pond is ignored on the other, despite the fact that it may have significant clinical consequences as seems to be the case with Stryker’s Wingspan Neurovascular Stent.
FDA Approves Abbott’s Omnilink Elite® Vascular Balloon-Expandable Stent System For Treatment Of Iliac Artery Disease
Abbott has announced U.S FDA approval for its Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. The stent, already CE marked and marketed in Europe, has passed muster with the FDA following a comparative multicentre clinical study which suggested it outperforms endpoints established from previous stent studies..
First-In-Human Use For ART’s Bioresorbable Stent
ART reckons its bioresorbable coronary stent will disappear in a predictable timeframe because of its “programmed transitory presence”. Despite the sci-fi language it sounds like a smart product if it works… time will tell as the company undertakes its first in man clinical study.
Stent Sales Pour A Bit Of Cold Water On Abbott’s Strong Q2 Financials
Abbott has announced its financial results for the second quarter ended June 30, 2012. Reported sales increased 2.0 percent, including an unfavourable 4.7 percent effect of foreign exchange. Stent sales suffered due to the wind-down of the supply arrangement with Boston Scientific, but recent Xience news gives reason for optimism.
Now Xlumena’s Axios Stent CE Mark Approval Includes Biliary Tract Drainage
Xlumena, Inc. has announced that it has received CE Mark approval to market its AXIOS Stent and Delivery System for biliary tract drainage. The device was previously approved for the treatment of pancreatic pseudocysts.
FDA Clears FSS FlexStent® Biliary Self-Expanding Stent System Range Extensions
Flexible Stenting Solutions inc., has announced receipt of FDA 510(k) clearance for an increased range of sizes of its FlexStent® Biliary Self-Expanding Stent System, including 9 and 10 mm diameters in lengths up to 100 mm.
FDA Clearance For Cook Medical’s Evolution® Colonic Controlled-Release Stent
Cook Medical has gained 510(k) clearance for its Evolution® Colonic Controlled-Release Stent. The new stent is used to palliate uncomfortable symptoms associated with colonic obstructions caused by malignant neoplasms and relieve large-bowel obstructions prior to colectomy procedures.
Flexible Stent Solutions’ Flexstent Iliac Iteration CE Marked
Flexible Stent Solutions has been granted CE mark for an extended range of its Flexstent peripheral vascular stents. The new line, called Flextent Iliac, does pretty much what it says on the tin, extending the company’s offering to cover more vessels.
Medtronic Wins U.S. Stent Graft Patent Case, But Gets Sued For Confusing A University
The life of a medtech company is never straightforward is it? Just as Medtronic is celebrating victory in a stent graft patent case involving W.L.Gore it also emerges that it is being sued for historical royalty payments of at least $7M, which a University claims it is due because of confusing accounting practices.
OrbusNeich’s Genous™ Stent An Option When Extended Dual Antiplatelet Therapy Isn’t
Impressive new data from a sizeable study population suggests that OrbusNeich’s clever pro-healing Genous™ stent may perform as well without dual antiplatelet therapy as it does with it.
FDA Provides Info On Boston Scientific’s Promus Element™ Plus Stent
FDA has provided useful information on the recently approved Promus Element™ Plus drug eluting stent family of products from Bostons Scientific.
Asher Holzer Retires As President Of InspireMD
InspireMD has announced that its president and co-founder Asher Holzer, Ph.D., is retiring as president of the Company.
Global Bare Metal Stents Market To Reach $1.86Bn By 2015 Says New Market Research Report
A new market research report has been published which claims bare metal stents will account for $1.86Bn sales by 2015. And if you buy it you get a free hour with an analyst.
FDA Approves Longer Lengths Of PROMUS Element Plus Stent
Boston Scientific Corporation has announced the gaining of FDA clearance of two longer lengths (32mm and 38mm) of its PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, opening the door for the treatment of longer lesions.