Author: Ken Dropiewski

Intact Vascular Announces Completion of Enrollment in the Tack Optimized Balloon Angioplasty II (TOBA II) Clinical Trial

WAYNE, Pa.–(BUSINESS WIRE)– Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial has completed enrollment. A total of 210 patients have been enrolled in TOBA II at 33 sites in the U.S. […]

Texas Cardiac Arrhythmia Institute at St. David’s Medical Center First in Texas and Among First in U.S. to Use FlexAbility™ Ablation Catheter, Sensor Enabled™

AUSTIN, Texas, March 21, 2017 /PRNewswire/ — On March 1, 2017, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center was the first in Texas and among the first facilities in the U.S. to use the FlexAbility™ Ablation Catheter, Sensor Enabled™, designed to improve versatility and precision during […]

Tryton Medical Announces First U.S. Commercial Case with Tryton Side Branch Stent

DURHAM, N.C.–(BUSINESS WIRE)– Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, today announced that the first U.S. commercial case using the Tryton Side Branch Stent to treat a coronary bifurcation lesion involving a large side branch (appropriate for a ≥2.5mm stent) was completed at […]

BioStable Science & Engineering Wins FDA Nod for Its HAART 300 Aortic Annuloplasty Device

BioStable Science & Engineering Announces FDA Clearance of the HAART™ 300 Aortic Annuloplasty Device AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair. BioStable expects […]

FDA Green Lights Medtronic (MDT)’s CoreValve Evolut Pro Transcatheter Valve With Advanced Sealing

Press Release Medtronic Receives FDA Approval for CoreValve(TM) Evolut(TM) Pro Transcatheter Valve with Advanced Sealing DUBLIN – March 22, 2017 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM)Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic […]

Dr. Mary Norine Walsh Assumes American College of Cardiology Presidency

WASHINGTON, March 19, 2017 /PRNewswire-USNewswire/ — Mary Norine Walsh, MD, FACC, today becomes president of the American College of Cardiology during the Convocation Ceremony held in conjunction with the ACC’s 66th Annual Scientific Session in Washington. Walsh is the director of the heart failure and cardiac transplantation programs and director of […]

AliveCor Unveils First AI-Enabled Platform for Doctors to Improve Stroke Prevention Through Early Atrial Fibrillation Detection

MOUNTAIN VIEW, Calif., March 16, 2017 /PRNewswire/ — AliveCor, the leader in FDA-cleared mobile electrocardiogram (ECG) technology, today announced the U.S. release of Kardia Pro, an industry-first artificial intelligence-enabled platform for doctors to monitor patients for the early detection of atrial fibrillation, the most common cardiac arrhythmia that leads to […]

RaySafe unveils new real-time dosimeter

BILLDAL, Sweden, March 7, 2017 /PRNewswire/ — Unfors RaySafe has introduced the RaySafe i3, to its suite of real-time dosimetry products, at the European Society of Radiology in Vienna. The RaySafe Real-Time Dosimetry solution, introduced in 2012, helps physicians and clinical staff visualise X-ray exposure in real time using easy-to-read bar […]

Late-Breaking Data on Abbott’s MitraClip® System Show Continued Benefit for People with Mitral Regurgitation, Most Common Heart Valve Disease

WASHINGTON, March 18, 2017 /PRNewswire/ — Abbott (ABT) today announced favorable one-year outcomes from the largest study of real-world experience for the MitraClip system in transcatheter mitral valve repair (TMVR) procedures in the United States. MitraClip treats people with degenerative mitral regurgitation (DMR, also known as leaky heart valve), a […]