Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
A prospective, multi-center, multi-national single arm study to evaluate the performance and
 safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and
 vascular surgery.
A prospective, multi-center, multi-national single arm study conducted in Austria, France,
 and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in open
 gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will
 be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical
 specialty.
Pre-operative Inclusion Criteria:

 -  Patient is undergoing a non-emergent open gynecological, urological, ENT, head and
 neck, or vascular surgery

 -  Patient is willing and able to give prior written informed consent for investigation
 participation;

 -  Patient is 18 years of age or older.

 Intra-operative Inclusion Criteria

 -  Patient has one or more target bleeding sites (TBS) for which control of bleeding by
 conventional procedures is ineffective or impractical.

 -  The TBS(s) has been treated with HEMOBLASTTM Bellows as per their instructions for
 use.

 Exclusion Criteria:

 -  Patient is pregnant, planning on becoming pregnant during the follow-up period, or
 actively breast-feeding;

 -  Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or
 any other component(s) of the hemostatic agent;

 -  Patient has religious or other objections to porcine, bovine, or human components;

 -  Patient has any significant coagulation disorder;

 -  Patient has any other contraindications, warnings, precautions of the Approved
 Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion

 -  Patient is not appropriate for inclusion in the clinical trial, per the medical
 opinion of the Investigator