July 26, 2011 – The Resolute drug-eluting stent (DES) from Medtronic Inc. showed superiority to Boston Scientific Corp.’s Taxus DES on in-stent late lumen loss at eight months, the primary endpoint of the RESOLUTE Japan clinical study.

 

July 25, 2011 —Siemens Healthcare announced that syngo Neuro PBV IR (parenchymal blood volume interventional radiology) has received U.S. Food and Drug Administration (FDA) 510(k) marketing clearance. The software package is intended to provide visual assistance to physicians in the diagnosis and treatment of vessel malformations (such as aneurysms, arteriovenous malformations and stenoses).

July 25, 2011 — Cardiac Science Corp., manufacturer of automated external defibrillators (AEDs) and diagnostic cardiac monitoring devices, announced the new capability of direct communication between its HeartCentrix connectivity solution and the GE Healthcare Centricity EMR system.

July 25, 2011 — Memorial Hospital of South Bend, Ind., installed the 100th Philips interventional X-ray system with electrophysiology (EP) cockpit XL. The system includes an Allura Xper FD 10, EP cockpit workflow solution and EP navigator cardiac visualization tool.

The U.S. Food and Drug Administration (FDA) said it is amending the classification regulation for electrocardiograph (ECG) electrodes into a class II device category, exempting these devices from FDA clearances. This rule is effective as of Aug. 22, 2011.

July 21, 2011 – The U.S. Food and Drug Administration (FDA) today approved AstraZeneca’s blood-thinning drug ticagrelor (Brilinta) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). The new class of antiplatelet therapy drug offers greater benefits over the current standard of clopidogrel (Plavix). The new drug is also the first with the ability to have its effects reversed quickly, reducing bleeding complications if a patient requires surgery or suffers trauma.

 

 

July 21, 2011 – Concentric Medical Inc. announced the launch of the expanded family of Merci Retrievers in Japan for the treatment of ischemic stroke. With the addition of the V 2.0 Soft and V 3.0 Soft, through recent Ichihen Approval, the entire family of V Series Merci Retrievers are now approved and reimbursed in Japan. The Merci Retriever is a catheter-based medical device that stroke centers use to remove blood clots from the brains of patients suffering an ischemic stroke.


In a closely watched move viewed as a big step toward a paradigm shift in how heart valves are repaired in the United States, a U.S. Food and Drug Administration (FDA) advisory panel voted late yesterday to recommend approval of the Edwards Lifesciences Sapien transcatheter heart valve. The FDA Circulatory System Devices Panel recommended the valve specifically for the treatment of patients who are too sick to undergo the standard therapy of surgical valve replacement.

April 26, 2011 – The U.S. Food and Drug Administration (FDA) announced this week it cleared Boston Scientific’s Ion paclitaxel-eluting coronary stent system. 

The stent, available for use with monorail or over-the-wire delivery systems, is made of platinum chromium (PtCr) alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.  The stent’s alloy and design offer greater strength, enhanced deliverability and exceptional visibility.  The thin-strut stent is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution

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