Indication withdrawn

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

Subjects undergoing open gynecological, urological, ENT and head and neck, and vascular procedures that meet all of the inclusion criteria and none of the exclusion criteria.