Healio

Transcatheter pulmonic valve replacement system with adaptive prestent gains FDA approval

Please provide your email address to receive an email when new articles are posted on . Edwards Lifesciences announced it received FDA approval for its transcatheter valve with adaptive prestent for ...
TCTMD

Harmony TPV Continues to Reduce Pulmonary Valve Regurgitation at 1 Year

The findings come on the heels of the US Food and Drug Administration approving the Harmony system (Medtronic) in March as the first nonsurgical heart valve to treat pulmonary valve regurgitation in ...
TCTMD

FDA Clears SAPIEN 3 With Alterra Prestent for Pulmonary Valve Replacement

The US Food and Drug Administration (FDA) has cleared Edwards Lifesciences’ SAPIEN 3 transcatheter valve with the Alterra adaptive prestent for pulmonic heart valve replacement, the manufacturer ...
Nasdaq

Edwards Gets FDA Approval For SAPIEN 3 With Alterra For Transcatheter Pulmonic Valve Replacement

(RTTNews) - Edwards Lifesciences (EW) said it received approval from the U.S. Food and Drug Administration for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent ...
MedPage Today

Sapien 3 With Pre-Stent Gets FDA Go-Ahead for Pulmonary Valve Fix

Edwards Lifesciences announced the approval Monday for management of both pediatric and adult patients with severe pulmonary regurgitation on echocardiography who are candidates for surgical ...
Hoodline

Miami Kids’ Heart Institute Pulls Off Florida First With Rare Valve Fix

Nicklaus Children's says it's the first in Florida to perform a pediatric pulmonary Ozaki — a valve rebuilt from the child's own tissue.
Business Wire

Edwards Launches SAPIEN 3 With Alterra Prestent in Europe for Transcatheter Pulmonic Valve Implantation

NYON, Switzerland--(BUSINESS WIRE)--Edwards Lifesciences today announced the launch in Europe of the SAPIEN 3 transcatheter pulmonary valve implantation (TPVI) system with Alterra adaptive prestent, ...
Medscape

FDA Okays Sapien 3 Heart Valve With Alterra Adaptive Prestent

The US Food and Drug Administration (FDA) has approved use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (Sapien 3 with Alterra) for patients with severe pulmonary ...
MD&M East

$2M Grant to Speed PolyVascular’s Pediatric Catheter-Delivered Pulmonary Valve Replacement to Market

Powered by SBIR grant funding, PolyVascular advances options for children in need of pulmonary valve replacement with its polymeric stent-mounted valve small enough for the tiniest patients. The ...
Nasdaq

Medtronic Receives FDA Approval for "Breakthrough" Transcatheter Pulmonary Valve Replacement for Patients with Congenital Heart Disease

Harmony™ Transcatheter Pulmonary Valve is First Minimally Invasive Alternative for Patients with Severe Pulmonary Regurgitation Who Have a Native or Surgically-Repaired Right Ventricular Outflow Tract ...
Medscape

FDA OKs Transcatheter Pulmonary Valve for Congenital Heart Disease

The US Food and Drug Administration (FDA) has approved Medtronic's Harmony Transcatheter Pulmonary Valve (TPV) System to treat severe pulmonary regurgitation in pediatric and adult patients who have a ...