Zenith (Q4253)
Zenith (Q4253)
Amniotic Membrane Allograft
Zenith Amniotic Membrane is a sterile allograft designed for optimal wound covering and protection during the treatment of wounds.
Amniotic Key Features & Properties:
- Provides a reliable protective wound covering backed by decades of science
- Dehydrated extracellular matrix acts as a scaffold supporting the native tissue
- Adheres easily to wounds including those with irregular surfaces
- 5-year shelf life at ambient temperature storage
Zenith is an amniotic membrane allograft derived from a prescreened mother with a planned delivery. Zenith is manufactured in compliance with FDA regulations and AATB guidance. The membrane is minimally processed to preserve the native structure of the tissue, dehydrated, and terminally sterilized. Zenith is confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271
Zenith Case Study 1
Case presented by Jacob Fassman, DPM; Podiatrist; Colorado Foot and Ankle; Colorado Springs, CO
A 77 YEAR OLD FEMALE with H/O left leg venous insufficiency and previous venous ulcerations. Left leg wound started with trauma from car door one month prior. Applied collagenase ointment daily for four weeks without significant improvement.
- Location: Left leg
Wound type: Venous ulcer
Weeks to resolution: 8
Total number of Impax applications: 7
Size: 2 x 1.5 x 0.1 cm
WEEK 1 Debridement with application of 2 x 3 cm Zenith
Size: Wound resolved
WEEK 8 After additional Zenith application in week 7, wound healed
Size: 1.3 x 0.9 x 0.1 cm | Volume reduced: 44%
WEEK 3 After debridement, application of 2 x 3 cm Zenith
Size: 1.2 x 0.5 x 0.1 cm | Volume reduced: 52%
WEEK 5 After additional Zenith in week 4, patient is improving; fifth 2 x 3 cm Zenith applied after debridement
Size: 1.3 x 0.3 x 0.1 cm | Volume reduced: 35%
WEEK 6 After debridement, application of 2 x 3 cm Zenith
Size: 1.6 x 1.3 x 0.1 cm | Volume reduced: 31%
WEEK 2 After debridement, application of 2 x 3 cm Zenith