June 25, 2013 — Cordis Corp. announced the European CE marking and U.S. Food and Drug Administration (FDA) approval of additional sizes of its Sleek OTW (over-the-wire) platform, a 0.014-inch ultra-low profile percutaneous transluminal angioplasty (PTA) dilatation catheter.

AliveCor Inc.’s Heart Monitor for iPhone 4, 4S and 5 is now available for purchase in the United Kingdom and Ireland. It is the first CE-marked mobile device–based electrocardiogram (ECG) monitor that is used to record, display, store and transfer single-channel ECG rhythms. It is available to medical professionals, patients and health-conscious individuals at Amazon.co.uk.

Aptus Endosystems Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 28 mm Tip Reach Heli-FX Guide. A line extension of the original Heli-FX System, the new product enhances treatment of wide neck abdominal aortic aneurysms (AAA). The announcement comes ahead of this week’s Society of Vascular Surgery (SVS) Vascular Annual Meeting in San Francisco where the company will be launching this device as well as the recently approved Heli-FX Thoracic System.

Final six and 12-month results of the DIRECT first-in-man clinical study were presented by study principal investigator Dr. Mark Webster at the late-breaking clinical trials session of the EuroPCR meeting in Paris, France. No patients experienced clinically-driven TLR, TVR or MACE at six months, with results sustained through 12 months. It is believed the Svelte drug-eluting stent is the first ever to achieve 0 percent clinically-driven MACE through 12-months in a independent core-lab and DSMB adjudicated clinical study.


The Idaho Health Data Exchange (IHDE) and St. Luke’s Health System (SLHS) have launched Image Exchange viewing capability by eHealthTechnologies.

Cardiovascular Systems Inc. (CSI) announced that the first patient has been enrolled in its post-market clinical study, LIBERTY 360°. The study is evaluating the acute and long-term clinical and economic outcomes of CSI’s orbital atherectomy system in treating peripheral arterial disease (PAD). Additionally, LIBERTY 360° is the first study of its kind to compare orbital atherectomy to all other PAD treatment options in a difficult-to-treat patient population. Cezar Staniloae, NYU Medical Center / New York Cardiovascular Associates, N.Y., the study’s principal investigator, performed the first procedure.

Biosensors International Group Ltd. has entered into a licensing agreement with Eurocor GmbH, a group company of Opto Circuits (India) Ltd. for their drug eluting balloon (DEB) technology and related intellectual property (IP) rights in relation to the treatment of both coronary and peripheral artery disease. As a first step in this process, an original equipment manufacturer (OEM) arrangement is being implemented, whereby Biosensors will market and sell, under its own brand, DEBs manufactured by Eurocor.

June 19, 2013 — Coronary artery disease (CAD) is one of the world’s most prevalent and silent killers. Positron emission tomography (PET), which images miniscule abnormalities in cellular metabolism, can tip off clinicians about cardiac disasters waiting to happen — including sudden death from a heart attack — better than standard angiography, researchers revealed at the Society of Nuclear Medicine and Molecular Imaging’s 2013 Annual Meeting.

Magnetic resonance imaging (MRI) scans of children who have had chemotherapy can detect early changes in their hearts finds research in biomed Central's open access journal Journal of Cardiovascular Magnetic Resonance.

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