Healthcare Industry News:  osteoporosis 

Devices Surgery FDA

 News Release - April 6, 2010

Baxter and Nycomed Announce FDA Approval of TachoSil(R)

TachoSil indicated for use as an adjunct to hemostasis in cardiovascular surgery

DEERFIELD, Ill.--(HSMN NewsFeed)--Baxter International Inc. (NYSE: BAX ) and Nycomed today announced the U.S. Food and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil is the first and only adjunctive hemostatic agent available in the U.S. that combines a collagen patch with a coating of human coagulation factors. This ready-to-use patch can be applied directly to the bleeding area either dry or wet. In the presence of saline, blood or other bodily fluids, the coagulation factors dissolve to form a fibrin clot, which adheres the TachoSil patch to the bleeding surface and achieves hemostasis.

“Controlling bleeding has always been a challenge in cardiovascular surgery, and we are constantly looking for new ways to achieve hemostasis effectively,” said Dr. Yoshiya Toyoda, M.D., Ph.D., Head of Cardiothoracic Transplantation at the Heart, Lung and Esophageal Surgery Institute at the University of Pittsburgh Medical Center (UPMC). “As a ready-to-use patch, TachoSil represents a new and different option, which I believe will be a welcomed addition to the armamentarium of adjunctive hemostasis products used in cardiovascular surgery today.”

TachoSil is a patented Nycomed product that is currently available in more than 50 markets outside of the U.S. Baxter holds exclusive rights to market and distribute TachoSil in the U.S. Nycomed will manufacture the product and holds the license with the FDA. Baxter plans to launch TachoSil during the second half of 2010.

“TachoSil is the first and only product of its kind approved by the FDA, and an important addition to our BioSurgery line of products,” said Ron Lloyd, vice president and general manager of Baxter’s Regenerative Medicine business. “The approval of TachoSil and our recently announced acquisition in the orthobiologics space underscore Baxter’s commitment to continued growth and leadership across all facets of our BioSurgery business.”

Important Risk Information

TachoSil is indicated as an adjunct to hemostasis for use in cardiovascular surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

Do not use TachoSil in renal pelvis or ureter procedures, neurosurgical procedures, or in the closure of skin incisions.

Apply on the surface of tissue only. Do not apply TachoSil intravascularly. Intravascular application may result in life-threatening thromboembolic events. Do not use TachoSil in individuals known to have anaphylactic or severe systemic reaction to human blood products or horse proteins.

Do not use TachoSil for the treatment of severe or brisk arterial bleeding. Do not use TachoSil as the primarymode to control hemostasis. TachoSil is not intended as a substitute for meticulous surgical technique and the proper application of suture, ligature or other conventional procedures for hemostasis.

Hypersensitivity or allergic/anaphylactoid reactions may occur with TachoSil. Symptoms associated with allergic anaphylactic reactions include: flush, urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia, dyspnea, severe hypotension and anaphylactic shock. These reactions may occur in patients receiving TachoSil for the first time or may increase with repetitive applications of TachoSil. In the event of hypersensitivity reactions, discontinue administration of TachoSil. Do not leave TachoSil in an infected or contaminated space.

When placing TachoSil into cavities or closed spaces, avoid overpacking. Use only the minimum amount of TachoSil patches necessary to achieve hemostasis. The active substances of TachoSil are made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease.

In the cardiovascular study the most frequently reported adverse reactions were atrial fibrillation (18 patients [29.0%] in the TachoSil group and 14 patients [24.6%] in the comparator group) and pleural effusion (14 patients [22.6%] in the TachoSil group and 11 patients [19.3%] in the comparator group).

About Nycomed

Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.

Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the U.S. and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.

Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2009 and an adjusted EBITDA of €1.1 billion.

For more information visit www.nycomed.com.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning expectations with respect to the launch of TachoSil. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: completion of final steps in product development, including scaling up production and satisfactory quality and regulatory work; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s web site. Baxter does not undertake to update its forward-looking statements.


Source: Baxter International

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