ENTact™ Septal Stapler Shelf Life Extension

A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life

This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.

Inclusion Criteria:

• Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.

• Patient is able to provide a signed informed consent form.

• Patient will agree to comply with all study related procedures.

• Subject is not pregnant at this time by confirmation of one of the following:

  • subject is male,
  • subject not of child bearing age,
  • subject is surgically sterile,
  • subject is not pregnant per negative hCG test.

• Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.

Exclusion Criteria:

• Patients who have had previous septoplasty

• Patients with uncontrolled diabetes

• Presence of infection at the study site

• Subject is a:

  • smoker,
  • severe drug abuser,
  • severe alcohol abuser.

• Patient with autoimmune disease deemed clinically significant by the Principal Investigator.