CoreValve Outperformed by Sapien XT in First Randomised Study

It’s only one study, but it’s perhaps telling that the theoretical advantages of a balloon-expandable transcatheter valve design seem to carry through into clinical reality as procedural success for Sapien XT significantly outstrips its rival CoreValve.

FDA Approves Abbott’s Supera® Stent to Treat People with Peripheral Artery Disease

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.

Barrx Treatment Group Significantly Outperforms Control in Barrett’s Esophagus

Results of a new clinical study into the Barrx RF Ablation platform, acquired by Covidien back in late 2011, say the therapy is effective at treating Barrett’s esophagus. So effective that the trial was stopped and the control group offered the treatment.

FDA Approves St. Jude’s Allure Quadra™, Assurity™ and Endurity™ Devices

St. Jude Medical, Inc. has announced approval from the U.S. FDA for the Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which provides additional pacing innovations for physicians to treat patients with heart failure. The company also announced FDA approvals for the Assurity™ pacemaker and Endurity™ pacemaker families of devices.

CE Mark and EU Launch for St. Jude’s Prodigy Spinal Cord Stimulation System with Burst Technology

St. Jude Medical, Inc. has seen its Prodigy™ Chronic Pain System with Burst Technology gain CE Mark approval, which it says will be followed by European launch.

$34 Million Financing for Commercialisation of NinePoint Medical’s NvisionVLE™ Imaging System

Imaging device Specialist NinePoint Medical, Inc., has completed a $34 million Series B financing which it says will support the ongoing commercial launch of the NvisionVLE Imaging System in the U.S., as well as development of the company’s expanded product offering.

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