January 29, 2013
LeGoo Full Commercial Availability
Sanofi Launches Breakthrough Technology for Cardiovascular and Vascular Surgery Procedures
--LeGoo® proprietary gel technology provides clear surgical field for cardiothoracic and vascular surgeons without trauma to blood vessels--
Bridgewater, New Jersey – January 29, 2013 – Sanofi US announced the commercial launch of LeGoo®, a biopolymer gel that allows surgeons to temporarily stop blood flow during surgery without the use of clamps, elastic loops or other conventional occlusion devices, which may increase risk of trauma to blood vessels. The atraumatic occlusion technique potentially provides clear visualization with less clutter while maintaining vessel integrity. The announcement was made in conjunction with this year’s annual Society of Thoracic Surgeons (STS) Meeting, which is being held in Los Angeles this week.
As the first and only atraumatic intraluminal occlusion gel, LeGoo is injected into a blood vessel and forms a plug that molds to the shape of the vessel, stopping blood flow temporarily. The plug custom-adapts to the contour of each individual blood vessel, delivering a truly sophisticated approach to surgical procedures. Upon completion of the anastomosis, LeGoo is dissolved spontaneously in about 15 minutes or by cooling the vessel directly through ice application or cold saline infusion, which restores blood flow.
"LeGoo represents an elegantly simple and atraumatic solution to temporary vessel occlusion,” David H. Deaton, MD FACS, Chief, Vascular and Endovascular Surgery, MedStar Georgetown University Hospital. “The fluid nature of LeGoo adapts to any arterial anatomy irrespective of shape or calcific disease, delivering a truly sophisticated and flexible approach to vascular anastomoses and providing a clear surgical field. LeGoo is an innovative advance in cardiovascular surgery.”
LeGoo was approved in the United States in October 2011 for temporary atraumatic occlusion of blood vessels up to 4mm in diameter below the neck. The need for temporary atraumatic vascular occlusion and a bloodless field exists in numerous surgical applications, though the current focus for LeGoo is in cardiac and peripheral vascular surgery. It is CE-marked and has been used in more than 3,000 procedures in Europe. In a randomized multicenter study of 110 patients undergoing off-pump coronary artery bypass graft surgery, LeGoo provided satisfactory hemostasis in a statistically significant higher percentage of vessel grafts.
“LeGoo has the potential to change the paradigm of vascular and cardiovascular surgical procedures through a completely new approach to a long-accepted standard of care," said Anne Whitaker, President, North America Pharmaceuticals. "The commercial launch of LeGoo is one of several innovations Sanofi is launching in 2013 and proof of our commitment to finding new health care solutions by putting patients first while also diversifying our Biosurgery portfolio.”
Sanofi acquired Pluromed, the company that invented LeGoo, in March 2012 to add to its biosurgery portfolio and support its commitment to remain at the forefront of innovative approaches to drug discovery and surgical device development to help patients live longer, healthier lives.
LeGoo® is a thermo-sensitive biocompatible and non-toxic liquid gel that forms a plug when injected into a blood vessel to temporarily stop blood flow. The plug dissolves rapidly via cooling or spontaneously after several minutes. Once dissolved, the plug cannot reform because the concentration is too low. In a prospective, randomized study, LeGoo was shown to provide better operating conditions than conventional occlusion techniques by limiting blood flow into a surgical field without causing damage to the vessels. The study also showed a reduction in the time required to perform an anastomosis for beating heart surgery when using LeGoo. Time is critical to patient outcomes in these types of surgical interventions.
Important Safety Information
LeGoo should only be used by physicians properly trained in vascular occlusion techniques. LeGoo should not be used in patients with vascular anatomy or blood flow that precludes cannula placement or proper injection and control of LeGoo or in patients intolerant to vascular occlusion or where temporary vascular occlusion would be contraindicated. Do not inject LeGoo into a vessel that is not intended to be occluded. Always use the minimum volume of LeGoo required to achieve satisfactory occlusion. LeGoo dissolves naturally and re-application may be necessary to maintain temporary blood vessel occlusion. Excessive or prolonged vessel occlusion may result in increased ischemic risks to the patient. Adverse Events (AEs) in clinical studies with LeGoo are consistent with anticipated AEs for patients undergoing cardiovascular surgery. Additional safety and Adverse Event information for LeGoo are described in the Instructions for Use (IFU).
About Sanofi Biosurgery
Sanofi Biosurgery is a global strategic business unit of Sanofi. It develops and markets innovative, biologically based products for osteoarthritis relief, adhesion prevention, cartilage repair, and severe burn treatment. Sanofi Biosurgery's products include: Synvisc®, Synvisc-One™ (hylan G-F 20), Carticel® (autologous cultured chondrocytes), MACI® (Matrix-induced Autologous Chondrocyte Implantation), Seprafilm® and Epicel® (cultured epidermal autografts). Sanofi Biosurgery is committed to transforming disease management through innovative medical interventions.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as Sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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