News | Structural Heart | March 02, 2016

FDA Clears Sapien for Pulmonary Valve

The FDA approval expands use of the Edwards Sapien XT transcatheter heart valve for pulmonic valve replacement procedures

Edwards Lifesciences Corp. announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards Sapien XT transcatheter heart valve for pulmonic valve replacement procedures. The approval enables the treatment of adult and pediatric patients who suffer from either a narrowed pulmonary valve or moderate or greater pulmonary regurgitation caused by congenital heart disease.

"U.S. approval of the Sapien XT valve for pulmonic procedures provides an important, minimally invasive treatment option for a small group of patients who typically face the burden of multiple open-heart surgeries, oftentimes beginning at birth or during childhood. As risks increase with each open-heart surgery, a non-surgical option can help them receive treatment, recover and return to normal activities sooner," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves.

FDA approval of the Edwards Sapien XT valve for pulmonic procedures was supported by data from the multicenter COMPASSION clinical trial and additional clinical data from Europe. As previously indicated, the commercial opportunity related to this approval is small and is factored into 2016 financial expectations.

For more information: www.edwards.com 


Related Content

News | Structural Heart

September 26, 2022 — Medtronic plc, a global leader in medical technology, announced U.S. Food and Drug Administration ...

Home September 26, 2022
Home
News | Structural Heart

September 20, 2022 — Results of the first randomized controlled trial to directly compare two contemporary transcatheter ...

Home September 20, 2022
Home
News | Structural Heart

September 17, 2022 — Abbott today announced data from five late-breaking presentations showing the benefits of its ...

Home September 17, 2022
Home
News | Structural Heart

September 17, 2022 — Medtronic today announced findings from its Pathological Study of Hypo-Attenuated Leaflet ...

Home September 17, 2022
Home
News | Structural Heart

September 13, 2022 — The ŌNŌ endovascular retrieval system was recently used to remove a malpositioned leadless ...

Home September 13, 2022
Home
News | Structural Heart

August 9, 2022 — Atrium Health Sanger Heart and Vascular Institute has hit a milestone in heart care, having performed 2 ...

Home August 09, 2022
Home
News | Structural Heart

June 9, 2022 — Abbott announced late-breaking data for MitraClip, the world's first transcatheter edge-to-edge repair ...

Home June 09, 2022
Home
News | Structural Heart

May 25, 2022 — ŌNŌCOR LLC, a leader in endovascular safety technology, today announced it has received 510(k) U.S. Food ...

Home May 25, 2022
Home
News | Structural Heart

May 20, 2022 — Abbott announced two late-breaking data presentations highlighting both TriClip, a first-of-its kind ...

Home May 20, 2022
Home
News | Structural Heart

May 16, 2022 — Philips, a global leader in health technology, announced at EuroPCR (17 - 20 May 2022, Paris, France) the ...

Home May 16, 2022
Home
Subscribe Now