Investigators unveiled late-breaking clinical data from a first-of-its-kind physician sponsored clinical trial at the 2019 EuroPCR Annual Meeting, May 20-23 in Paris, France. The data indicate that renal denervation (RDN) with the Medtronic Symplicity renal denervation system was associated with reduced occurrence of subclinical atrial fibrillation (AF) in a small subset of high-risk patients with hypertensive heart disease over a median follow-up period of more than two years.

ControlRad Inc. announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its ControlRad Trace and the company has initiated its commercial launch. The ControlRad Trace is the only technology, according to the company, that can be integrated into existing mobile C-arms to reduce radiation in any fluoroscopic imaging procedure.

Illustration showing the catheter steps for the LAMPOON procedure designed to prevent left ventricular outflow tract (LVOT) obstruction . From Dr. Jaffar M. Khan and the Laboratory of Cardiovascular Intervention, led by Dr. Robert J. Lederman.
Figure 2: (Left) Illustration shows how, without LAMPOON, a transcatheter mitral valve implantation displaces the native anterior mitral valve leaflet causing LVOT obstruction. (Right) After LAMPOON, LVOT obstruction is reduced.Dr. Jaffar M. Khan and the Laboratory of Cardiovascular Intervention, led by Dr. Robert J. Lederman

Researchers at the National, Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), developed a novel technique that prevents the obstruction of blood flow in the left ventricular outflow tract (LVOT) during transcatheter mitral valve replacement (TMVR). LVOT obstruction  is a common fatal complication of TMVR, due to the close proximity off the aortic and mitral valves and the potential overhang of transcatheter valve blocking flow through the LVOT. 

Abiomed announced that the Impella CP with SmartAssist will be commercially available beginning at the 2019 Society for Cardiovascular Angiography & Interventions (SCAI) Scientific Sessions, May 19-22 in Las Vegas, through a controlled launch process at select sites. The majority of Impella CP heart pumps in the U.S. will be transitioned to SmartAssist over the next fiscal year.

Edwards Lifesciences Corp. announced strategic clinical and regulatory milestones for its Edwards Pascal transcatheter valve repair system at the EuroPCR annual course, May 20-23 in Paris, France. New 6-month data from the CLASP study of the Pascal system were presented by Konstantinos Spargias, M.D., from the Hygeia Hospital in Athens, Greece. In addition, the U.S. Food and Drug Administration (FDA) has approved CLASP IIF, a prospective, multicenter, randomized, controlled pivotal trial studying the PASCAL system.

Medtronic plc announced its entrance into the guide extension catheter market with the global launch of the Telescope Guide Extension Catheter. The newly designed catheter is used to provide additional backup support and access to distal lesions. Guide extension catheters help deliver coronary stents, balloons and other interventional devices during angioplasty procedures that help to restore blood flow through the coronary and peripheral arteries.

Medical diagnostic artificial intelligence (AI) company MaxQ AI announced that Accipio Ax will begin shipping in August and will be available as the second part of the Accipio ICH Platform. Accipio Ax will provide new tools to support clinical assessment of intracranial hemorrhage (ICH). Radiology departments, emergency room and neuroradiology teams across the U.S. and the EU will soon be able to access a comprehensive solution for ICH triage through workflow prioritization and slice-level preview. Accipio Ax includes the exclusive Accipio Ax SliceMap, an integrated view which guides clinicians rapidly to computed tomography (CT) slices with suspected ICH without leaving their picture archiving and communication system (PACS) viewer.

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