Bayer HealthCare Pharmaceuticals' RECOTHROM solution receives Health Canada approval

RECOTHROM(R) provides an aid to hemostasis on demand, allowing surgeons to deal with bleeding and complete the surgical procedure

Bayer HealthCare Pharmaceuticals announced today that RECOTHROM(R) (Thrombin alfa (Recombinant)), the first recombinant, plasma-free thrombin approved by Health Canada, is now available for use as a topical hemostatic solution. According to a recent clinical study, RECOTHROM(R) was found to successfully stop 80 per cent of surgical bleeding within three minutes and 95 per cent of bleeding within 10 minutes.

"Perioperative bleeding remains a significant issue in cardiac surgery as it is associated with an increased mortality, increased intensive care unit stay as well as increased morbidity in patients who suffer from that condition," said Dr. Mackenzie Quantz, Associate Professor, Cardiac Surgery, Surgical Director of Heart Transplantation, London Health Sciences Centre.

"RECOTHROM(R) is a valuable addition to our existing surgical tools and is especially useful for patients with diffuse oozing from raw surface tissue. Because RECOTHROM(R) is a recombinant product, there is very low risk of immunogenicity which is especially important in our cardiac patients because of the risk of re-operation," added Dr. Quantz.

"Based on a clinical trial, surgeons will find RECOTHROM(R) to be a convenient surgical hemostat. RECOTHROM(R) is easy to prepare and use. It requires no refrigeration and can be stored in the operating room. When reconstituted, it can be kept up to 24 hours for lengthy surgical procedures. The components are latex-free and the needle-free transfer device eliminates the risk of needlesticks," said Shurjeel Choudhri, MD, Senior Vice President and Head, Medical and Scientific Affairs, Bayer Inc.

RECOTHROM(R) is intended for topical use only. It may be applied directly to the bleeding site, or used in conjunction with a compatible absorbable gelatin sponge to promote hemostasis. When RECOTHROM(R) solution comes into contact with blood it helps clotting.