June 25, 2013 — Siemens Healthcare announced that the U.S. Food and Drug Administration (FDA) has cleared the Virtual Touch imaging ultrasound application, Siemens’ first commercially available implementation of Acoustic Radiation Force Impulse (ARFI) technology.

June 25, 2013 — Zoll Medical Corp. announced that a paper published in Critical Care Medicine reported the likelihood of achieving a return of spontaneous circulation (ROSC) after sudden cardiac arrest (SCA) is 62 percent greater when the AutoPulse noninvasive cardiac support pump is used to deliver CPR chest compressions.

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.

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