Abbott

Registry data suggests that use of MitraClip to reduce mitral valve regurgitation confers benefits in even severely ill patients.

Abbott has gained CE mark approval for its TECNIS® Symfony Extended Range of Vision intraocular lens (IOL) for the treatment of cataract patients who may also have a diminished ability to focus on near objects (presbyopia).

Abbott has announced the completion of enrollment of three clinical trials to support approvals of the company’s revolutionary Absorb™ Bioresorbable Vascular Scaffold (BVS) in the United States, Japan and China.

Abbott’s Supera® Peripheral Stent System has received U.S. FDA approval to treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). PAD occurs when fat and cholesterol buildup causes arteries outside of the heart to narrow, which reduces blood flow to parts of the body, most commonly the legs. The disease affects 12 to 20 percent of Americans age 65 or older and can cause leg pain, in addition to increasing the risk of heart attack or stroke.

FDA’s Mitraclip approval now means it’s available in the United States for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. New data at TCT2013 provides compelling clinical support for the device in this patient group.

Back in March things were looking a little up in the air for MitraClip as the FDA’s circulatory devices panel gave the clever device its thumbs up, despite the FDA’s summary document at the time saying there were still concerns. Seven months on and the device has received its US approval and will launch immediately in the United States.

Abbott has expanded its global peripheral technology portfolio with the acquisition of IDEV Technologies, a privately held company focused on developing next-generation medical devices for use by interventional radiologists, vascular surgeons and interventional cardiologists.

Last month we trailed the forthcoming acquisition by Abbott of privately held ophthalmic device company OptiMedica Corporation. And now the ink’s drying on the deal which sees Abbott’s vision care business expand into the femtosecond laser-assisted cataract surgery market.

Abbott has announced that it has received U.S. FDA clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System™, which it describes as an advanced blood glucose monitoring system designed to address the key needs of hospital customers.

Abbott’s purse strings are undeniably loose as it announces another acquisition, this time of ophthalmic device company OptiMedica Corporation. The acquisition will enable Abbott to expand its vision care business into the femtosecond laser-assisted cataract surgery market.

Abbott has entered into an agreement to purchase IDEV Technologies, a privately held company focused on developing next-generation medical devices … continue reading “Abbott’s New Acquisition Signals Intent in Global Peripheral Artery Disease Market”

Abbott has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the XIENCE Xpedition™ Everolimus Eluting Coronary … continue reading “Japanese Approval For Abbott’s XIENCE Xpedition™ Drug Eluting Stent”

Abbott is commencing a trial to study its innovative “Dissolving” Heart stent compared to its own drug-eluting stents in patients with Coronary Artery Disease.

Data from two European studies of Abbott’s MitraClip® therapy for the treatment of mitral regurgitation demonstrated low rates of hospital mortality and adverse events and significant improvements in day-to-day quality of life at one year following treatment

The newly CE marked XIENCE Xpedition™ 48 coronary stent leverages the well established design and clinical outcomes of the XIENCE Family of Drug Eluting Stents. A longer stent, compared with multiple short stents has the potential to reduce overall procedural costs, particularly in very long lesions most often seen in patients with diabetes.

The FDA has issued a Class I recall, it’s highest category, for Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters. … continue reading “FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters”