• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » TAVI: Sapien going strong at 3 years, but leak risk remains “overwhelmingly” higher

TAVI: Sapien going strong at 3 years, but leak risk remains “overwhelmingly” higher

March 11, 2013 By Arezu Sarvestani

Updated March 19, 2013, at 11:30 a.m. to reflect that the quote in paragraph 6 came from an ACC press release, not an Edwards press release.

Edwards Lifesciences Sapien TAVI system

Medical device maker Edwards Lifesciences (NYSE:EW) reported today that its Sapien transcatheter aortic valve implantation system appears durable and effective at 3 years compared with open-heart surgery, but that the risk of valve leakage is "overwhelmingly higher," researchers noted.

The medical device giant today unveiled the latest results from its PARTNER clinical trial, reporting that the Sapien technology proved similar at 3 years to surgical valve replacement for all-cause mortality, symptom improvement and stroke risk.

Procedure-related adverse events, however, remain a concern for the TAVI technology, including valve leakage and short-term stroke rates.

The news didn’t sit well with Wall Street, which sent EW shares down 2.4% to $88.11 as of about 2:30 p.m. EST today.

"In these 1st-generation transcatheter procedures, we have equivalent midterm outcomes between TAVR and the gold-standard surgical valve replacement in high-risk patients with severe aortic stenosis," said Dr. Vinod Thourani, who presented the trial results at today’s American College of Cardiology conference in San Francisco. "However, paravalvular leak continues to increase mortality at 3 years. Physicians should adopt innovative imaging technologies for more accurate sizing to help decrease these leak rates during TAVR."

"Leaks around the valve were common soon after the procedure and were overwhelmingly higher in the TAVR group," Thourani noted in an ACC press release.* "Even mild aortic leakage is associated with a higher mortality rate after any valve replacement procedure."

chart

A slide from Edwards Lifesciences’ presentation illustrating the differences in valve leakage between Sapien and surgery.
Click to enlarge.

The results were similar to those released at last year’s ACC conference, when Edwards Lifesciences reported 2-year findings from the PARTNER study.

The new findings highlighted the similarities between TAVI and surgical valve replacement in terms of all-cause mortality, cardiovascular mortality and stroke rates at 3 years.

At 6% the 30-day stroke rates for TAVI were significantly higher than the 3.2% reported for surgery, but TAVI narrowed that gap over the course of time. At 3 years the TAVI stroke rate was 8.2%, compared with surgery at 9.3%.

All-cause mortality was "nearly identical" with TAVI at 44.2% and surgery at 44.8%, and cardiovascular mortality was "statistically indistinguishable" with TAVI at 30.1% and surgery at 30.2%, according to the report.

Phase III of the PARTNER study will follow patients for 5 years, the company noted.

Filed Under: News Well, Replacement Heart Valves Tagged With: American College of Cardiology, American College of Cardiology Conference (ACC), Clinical Trials, Conference coverage, Edwards Lifesciences

More recent news

  • Omnipod 5 rollout for type 2 rolls on as Insulet pursues next-gen automation
  • Ancora Heart reaches enrollment milestone in pivotal heart failure device trial
  • PharmaSens, SiBionics innovatively combine tech in all-in-one insulin patch pump
  • Johnson & Johnson launches daily disposable multifocal toric contact lens
  • Study backs Biolinq intradermal sensor in muscle loss prevention during GLP-1 therapy

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy