Abbott has announced that the TECNIS® Toric 1-Piece intraocular lens has received U.S. FDA approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism.
Abbott
Mitral Valve Patients Urged To “Hold On” Until MitraClip Gets The Nod
We’ve opined before about the weird regulatory divide that sees life-saving technologies withheld from U.S. patients while being freely available in Europe. It seems the clinical community shares the view,as one physician/author shows her frustration at the continued unavailability of Abbott’s MitraClip.
FDA Panel Not Unanimous On MitraClip, But Approval Likely
In short What a peculiar and unusual series of events the final throes of MitraClip’s progress to FDA approval have … continue reading “FDA Panel Not Unanimous On MitraClip, But Approval Likely”
MitraClip Falls Short Of FDA Recommendation
FDA’s reading material, issued in advance of today’s PMA review meeting are not recommending the approval of the MitraClip implantable heart device, citing a lack of “valid scientific evidence” of safety and effectiveness. And a lack of comparator group.
Study Data Looks Good For Abbott’s Absorb™ Bioresorbable Vascular Scaffold
Positive long-term results for Abbott’s Absorb™ Bioresorbable Vascular Scaffold (BVS) Trial were presented at the 62nd Annual Scientific Session of the American College of Cardiology (ACC) in San Francisco. Three year results from 101 patients show cardiac event rate comparable with metal stents, but improved vasomotion and late lumen gain.
Abbott’s Minimally Invasive MitraClip® System for Mitral Regurgitation Demonstrates Positive Clinical and Quality-of-Life Results for Patients Too High Risk for Surgery
Data from Abbott’s EVEREST II High Surgical Risk cohort evaluating the company’s first-in-class catheter-based MitraClip® System for the treatment of mitral regurgitation were presented at the Annual Scientific Session of the American College of Cardiology in San Francisco over the weekend.
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.
Abbott Straight To Market With Newly FDA Approved Xpedition™ Drug Stent
Abbott’s XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has received U.S. FDA approval and is to be launched immediately in the United States.
International Coronary Artery Disease Patients Have Access To Abbott’s Absorb™ Bioresorbable Vascular Scaffold
Abbott says the potential long-term benefits of a scaffold that dissolves are significant and include a return of vessel function. CE mark and approval in many other countries sees availability widen for this first-in-class solution.
Mitraclip Registry Suggests Device Uptake For Older, Sicker Patients
Registry data presented at ESC suggests MitraClip use is gathering pace, at least for the oldest and sickest patients for whom it is providing an alternative to surgical valve repair.
CE Mark And EU Launch For Abbott’s XIENCE Xpedition™ “Extraordinarily Deliverable” Drug Stent
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.
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..
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.
FDA Approval For Abbott’s Healon EndoCoat Protective Gel for Cataract Surgery
Abbott has announced that it has expanded its Healon® family of ophthalmic viscosurgical devices (OVDs) with the FDA approval of Healon EndoCoat OVD, a device intended for use as a surgical aid in cataract extraction and intraocular lens (IOL) implantation.
Abbott Medical Claims Its Optics’ Tecnis Lens May Help Maintain Circadian Rhythm
Can the colour of your intraocular lenses affect your circadian rhythm and general health? Really? Our disbelief is suspended temporarily as Abbott Medical cites clinical evidence that it can.
New EU Min Three-Month Anti-Platelet Indication A First For Abbott’s XIENCE PRIME™ and XIENCE V® Drug Eluting Stents
Dual anti-platelet therapy is normally required for 6-12 months after implantation of a stent, with associated risks, costs and general inconvenience. No wonder then that Abbott is sounding pleased with itself as it gains the first indication of its kind to reduce the therapeutic period to a minimum of 3 months based on data from 10,000 patients.