October 28, 2016 — Medicure Inc. recently received U.S. Food and Drug Administration (FDA) market clearance for its new bolus vial product format for Aggrastat (tirofiban HCl) IV administered antiplatelet drug. It contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. It is indicated to reduce the rate of thrombotic cardiovascular events in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

Acutus Medical announced the completion of the first patient procedure in the “Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation” (UNCOVER-AF) clinical study. The study will evaluate the incidence of device and procedure-related safety, effectiveness and efficiency using the AcQMap High Resolution Imaging and Mapping System to guide ablation in persistent atrial fibrillation (AF) patients.

Volume matters when it comes to who does certain procedures to removing heart-attack causing blockages from arteries, according to a new study published recently in JACC: Cardiovascular Interventions.

October 27, 2016 — Corindus Vascular Robotics Inc. announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CorPath GRX, the second generation of its vascular robotic system. Corindus expects to commence commercialization of CorPath GRX in the first quarter of 2017.

Interventional cardiology, cath lab technology, TCT, transcatheter cardiovascular therapeutics

The volume of information attendees receive at the annual Transcatheter Cardiovascular Therapeutics (TCT) interventional cardiology conference can be overwhelming. So, to prepare for the meeting, here is a list of some key items that will be covered in sessions, live cases and late-breaking trial presentations. It includes videos, articles, news and U.S. Food and Drug Administration (FDA) clearances that will be among the hottest topics at this year’s TCT, in Washington, D.C., Oct. 30 - Nov. 2. 

October 27, 2016 — BioTrace Medical Inc. said it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Tempo Lead, an temporary pacing lead designed for use in procedures in which temporary pacing is indicated, including transcatheter aortic valve replacement (TAVR) and electrophysiology (EP) procedures.

Philips recently announced its latest image guidance solutions to be featured at the 2016 Transcatheter Cardiovascular Therapeutics meeting (TCT) in Washington, D.C., Oct. 29 – Nov. 2, 2016. Highlights will include the introduction of instant wave-Free Ratio (iFR) co-registration, which integrates iFR pullback data with the angiogram, and the third generation of HeartNavigator, live image guidance software for advanced structural heart disease procedures.

October 26, 2016 — The U.S. Food and Drug Administration (FDA) provided an update and additional information regarding patient safety issues involving the SynCardia Systems Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). The FDA also updated providers on recent events with an additional SynCardia pneumatic driver system, the Freedom Driver System. 

Medtronic announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve Evolut R 34 mm valve, now the largest sized transcatheter aortic valve replacement (TAVR) system available in the United States.

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