HEMOBLAST Pivotal Clinical Investigation

Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries

The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.

Inclusion Criteria:

• • Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery;

  • Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
  • Subject undergoing cardiothoracic surgery is not allergic to protamine; and
  • Subject is 21 years of age or older.

Exclusion Criteria:

• • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;

  • Subject is undergoing a neurologic surgical procedure;
  • Subject is undergoing a spinal surgical procedure;
  • Subject is undergoing an emergency surgical procedure;
  • Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
  • Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery;
  • Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery;
  • Subject receiving antiplatelet medications within 5 days prior to surgery;
  • Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery;
  • Subject has an active or suspected infection at the surgical site;
  • Subject has had or has planned to receive any organ transplantation;
  • Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
  • Subject has ASA classification of 5;
  • Subject has a life expectancy of less than 3 months;
  • Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;
  • Subject has a documented severe congenital or acquired immunodeficiency;
  • Subject has religious or other objections to porcine, bovine, or human components;
  • Subject in whom the investigational or control device will be used at the site of a valve replacement or repair;
  • Subject in whom the investigational or control device will be used at the site of a synthetic graft or patch implant;
  • Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and
  • Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.

Intraoperative Eligibility Criteria:

• Subject does not have an active or suspected infection at the surgical site;
• Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment;
• Subject in whom the Investigator is able to identify a TBS for which any applicable conventional means for hemostasis are ineffective or impractical; and
• Subject has a TBS with an SBSS score of 1, 2, or 3.