May 29, 2018 — The first placebo-controlled trial that looked at how fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) predicts the efficacy of percutaneous coronary intervention (PCI) found angioplasty improved ischemia. The invasive physiology data from 196 patients from the Objective Randomized Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina (ORBITA) Trial was presented as a late-breaking trial at the 2018 EuroPCR conference.


Here are the late-breaking trials and other key study presentations from the 2018 EuroPCR conference. This is the annual meeting of the European Association for Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology. It took place May 22-25, 2018 in Paris. The annual meeting attracts more than 10,000 attendees.

Late-breaking Trials at EuroPCR:


M.A. MedAlliance SA has raised $37 million to help develop and commercialize the first sirolimus micro-reservoir drug-coated balloon to treat patients suffering from peripheral artery disease (PAD). The Selution DCB is also intended to treat patients with coronary artery disease (CAD), arteriovenous fistulas (AVF) and grafts (AVG) for end-stage renal disease.

Medtronic plc announced the initiation of a U.S. clinical study to assess the safety and efficacy of drug-eluting stents (DES) for the treatment of bifurcation lesions. Bifurcation lesions account for approximately 20 percent of all percutaneous coronary interventions (PCI).[i] The Bifurcation Cohort, part of the RESOLUTE ONYX Post-Approval Study, will include patients with coronary artery disease (CAD) receiving the Resolute Onyx DES in sizes ranging from 2–5 mm in diameter.

May 25, 2018 — Data from the first-in-human study using pulsed electric field (PEF) energy ablate heart tissue in the treatment atrial fibrillation shows very positive evidence and may usher in a new era of tissue-specific, ultra-rapid ablation. This was according to researchers presenting this late-breaking study at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions.

Abbott announced favorable outcomes from the first 100 patients treated in a global study of its Tendyne Transcatheter Mitral Valve Replacement (TMVR) system. According to Abbott, Tendyne is the first and only mitral replacement valve that is repositionable and fully retrievable to allow for more precise implantation, helping improve patient outcomes. The trial is the largest study of a transcatheter mitral valve replacement device to date. Results at 30 days demonstrated that Tendyne is associated with a significant reduction of mitral regurgitation symptoms and low mortality rates.

Abbott announced it received approval from the U.S. Food and Drug Administration (FDA) for Xience Sierra, the newest generation of the company's Xience everolimus-eluting coronary stent system. Design and technology advances in this generation of the device include features specifically designed for the treatment of complex blockages that now account for up to 70 percent of cases.

Complex Interventional Cardiovascular Therapies (CICT)

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