Tendyne

STUDY IDENTIFIER:

Tendyne

CONDITION:

Severe Mitral Regurgitation

CONTACT INFO:

Pam Morley   |   Pamela.morley@allina.com   |   612-863-6066

DESCRIPTION:

The purpose of this expanded clinical study is to evaluate the performance and safety of the investigational Tendyne Mitral Valve System in severe mitral regurgitation in patients with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices.

CRITERIA LIST/ QUALIFICATIONS:

  • Severe mitral regurgitation of primary or secondary etiology.
  • NYHA functional Class ≥ II. If IV, patient must be ambulatory.
  • Heart team determines patient is not a suitable candidate for traditional surgical treatment.
 

INVESTIGATORS:

Wes Pedersen, MD

SPONSORS:

Tendyne Holdings, a subsidiary of Abbott Vascular

STATUS:

Open/Enrolling