Merck announced that the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA).

July 25, 2013 — The 2013 ESC (European Society of Cardiology) Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy, developed in collaboration with the European Heart Rhythm Association (EHRA), have created a new classification system for bradyarrhythmias according to mechanisms rather than aetiology.


Sanford Aberdeen Medical Center in Aberdeen, S.D. became the first hospital to perform a robotic angioplasty for a patient with an acute heart attack, achieving a far better door-to-balloon time than the national standard. Interventional cardiologist Puneet Sharma, performed the percutaneous coronary intervention (PCI) to treat a patient that had experienced a heart attack and presented to the Sanford Aberdeen emergency department. Utilizing the U.S. Food and Drug Administration (FDA)-cleared CorPath System, Sharma was able to perform the robotic-assisted angioplasty procedure and restore blood flow to the patient’s heart within 68 minutes of their arrival.


July 24, 2013 — St. Jude Medical Inc. announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and launch of the Accent MRI pacemaker and the Tendril MRI lead.


Infraredx Inc. announced the publication of key data supporting the ability of its TVC imaging system to detect lipid core plaque in patients with ST-segment elevation myocardial infarction (STEMI). The study, published in JACC: “Cardiovascular Interventions,” details the identification of a specific cholesterol signature by near-infrared spectroscopy (NIRS) at the site of the culprit lesions causing STEMI, a dangerous type of heart attack. While the TVC Imaging System has been used in more than 3,000 patients worldwide, the present clinical study is the first report of its use in a consecutive series of STEMI patients.


July 23, 2013 — BioVentrix, known for the Less Invasive Ventricular Enhancement (LIVE) procedure for the treatment of heart failure, announced publication of baseline and 12-month comparative data demonstrating the durability of its Revivent myocardial anchoring system in the first 11 patients treated with the device.

IMRIS has announced U.S. Food and Drug Administration (FDA) 510K clearance to market VISIUS iCT, the first and only ceiling-mounted intraoperative computed tomography (iCT) on the market.

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