Intended for US Audiences Only| Baxter Completes Acquisition of RECOTHROM and PREVELEAK to Broaden Surgical Hemostat and Sealant Portfolio |
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Both products complement and broaden Baxter’s existing surgical portfolio of hemostats and sealants. With RECOTHROM, Baxter can now provide surgeons with additional options of innovative hemostatic products to handle different severities of bleeding, while PREVELEAK complements its existing portfolio of advanced surgical sealants.
“We are excited to add both RECOTHROM and PREVELEAK to our portfolio of
hemostats and sealants to offer surgeons additional options that address
different situations when intraoperative bleeding can occur,” said
The deal is expected to be modestly accretive to Baxter’s 2018 adjusted
earnings and increasingly accretive thereafter. Under the terms of the
agreement, Baxter is acquiring RECOTHROM and PREVELEAK for an upfront
payment of approximately About Baxter’s Surgery Portfolio Baxter is committed to advancing surgical innovation with a variety of products and delivery devices used for hemostasis (addressing bleeding), tissue sealing, and hard tissue regeneration, as well as soft tissue repair and microsurgery. With products available in nearly 60 countries, Baxter is at the forefront of providing surgeons and hospitals with innovative products that improve patient outcomes, are convenient to use and are cost-effective. About Baxter
IMPORTANT SAFETY INFORMATION RECOTHROM Thrombin topical (Recombinant) Indication RECOTHROM Thrombin topical (Recombinant) is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. IMPORTANT RISK INFORMATION Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please see additional important risk information and Full Prescribing Information. PREVELEAK Surgical Sealant Indications PREVELEAK Surgical Sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. IMPORTANT RISK INFORMATION Contraindications • Not for use in patients with known allergies to materials of bovine or shellfish origin. • Not for intravascular use. • Not for cerebrovascular repair or cerebrospinal leak repair. Warnings and Precautions • Do not use as a substitute for sutures or staples. • Avoid exposure to nerves. • Do not use in the presence of obvious infection and use with caution in contaminated areas of the body. • Do not allow either the uncured or polymerized form to contact circulating blood. • PREVELEAK contains a material of animal origin that may be capable of transmitting infectious agents. • Repeated use of PREVELEAK in subsequent surgeries has not been studied. • Hypersensitivity reactions were not seen using PREVELEAK, but hypersensitivity of BSA has been reported. • Avoid contact with skin or other tissue not intended for application. • Safety and effectiveness of PREVELEAK in minimally invasive procedures or coronary artery bypass grafting (CABG) have not been established. • Do not use blood saving devices when suctioning excess PREVELEAK. • PREVELEAK syringe and delivery tips are for single patient use only. Do not resterilize. • Do not use if packages have been opened or damaged. • Take care not to spill contents of syringe. Avoid tissue contact with material expelled from delivery tip during priming. • Avoid pausing more than 10-15 seconds between priming and application to prevent polymerization within the delivery tip. • Minimize use in patients with abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyroidism). Polyaldehyde treated tissue can have an enhanced propensity for mineralization. • Evidence of cytotoxicity was observed during cell culturebased laboratory assays and is believed to be due to the polyaldehyde component of the product. No evidence of cytotoxicity was observed in animal or clinical studies. Adverse Reactions • Potential adverse effects associated with the use of this class of surgical sealants include application of the sealant to tissue not targeted for the procedure, failure of the sealant to adhere to the tissue, hypersensitivity reaction such as swelling or edema at the application site, possible transmission of infectious agents from materials of animal origin, thrombosis and thromboembolism. • Serious adverse events that occurred in clinical studies included death, hypotension, thrombosis/ thromboembolism, ischemia, respiratory failure/dysfunction, steal syndrome, and myocardial infarction. Use in Specific Populations • Use of PREVELEAK in pediatric or pregnant patients has not been studied.
This release includes forward-looking statements concerning the
company’s acquisition of two hemostat and sealant products from
Baxter is a registered trademark of View source version on businesswire.com: https://www.businesswire.com/news/home/20180319005550/en/ Source:
Baxter International Inc. |
