Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
The purpose of this post-market observational registry is to collect additional data on the
 safety and effectiveness of the HEMOBLAST™ Bellows device in total knee arthroplasty
 procedures.
A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.

 Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data
 collection will occur during the surgical procedure as well as during patient follow up and
 will follow site standard of care. Subjects will be discontinued from the study after
 completion of the final follow up visit. The estimated duration of the study is approximately
 10 months from the time of first subject enrollment to completion of the last subject follow
 up.
Preoperative Inclusion Criteria:

 -  Patient is undergoing a unilateral total knee arthroplasty procedure; and

 -  Patient is willing and able to give written informed consent for registry
 participation.

 Preoperative Exclusion Criteria:

 -  Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and

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

 Intraoperative Inclusion Criteria

 -  Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate
 bleeding for which conventional means for hemostasis are ineffective or impractical;
 and

 -  The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indication for Use.