Miromatrix Biological Mesh for Ventral Hernia Repair

A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02408458

Acronym

MIROMESH PM-1

Enrollment

Registered

2015-04-03

Start date

2015-06-30

Completion date

2016-04-30

Last updated

2017-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia

Brief summary

This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.

Detailed description

Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical mesh that is derived from the highly vascularized porcine liver. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for ventral hernia repair.

Interventions

DEVICEMIROMESH®

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* between 18 and 80 years old on the day of study enrollment * ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation * hernia classified as CDC class 1 or 2 preoperatively * able and willing to sign the consent form and comply with all study visits and procedures * commit to non-smoking for at least 4 weeks prior to procedure

Exclusion criteria

* sensitivity to porcine material * scheduled for a concomitant procedure of a wound classified as other than clean * immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator * BMI ≥40 * A1C level ≥10.0 * participating in another clinical study * cirrhosis, and/or ascites * diagnosed with a collagen vascular disorder * American Society of Anesthesiology (ASA) Class 4 or 5 * allergic to tetracycline or kanacmycin * life expectancy of less than 2 years at the time of enrollment * any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

Design outcomes

Primary

Measure	Time frame
Hernia recurrence requiring surgical intervention	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026