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.

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.

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.

Valtech Cardio Ltd. announced that two patients diagnosed with severe mitral regurgitation (MR) have been treated successfully with its Transfemoral Cardioband Annuloplasty System.

St. Jude Medical Inc. announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

Tryton Medical Inc. announced that the Nordic-Baltic Bifurcation Study Group will investigate the Tryton Side Branch Stent. The trial is a prospective, controlled, randomized, multicenter clinical study examining the role of final kissing balloon inflations in patient outcomes. A total of 150 patients will receive the Tryton Side Branch Stent with a drug-eluting stent, with evaluation by intravascular optical coherence tomography (OCT) imaging technology.