Diamond Bar, Calif., November 20, 2015 – Biosense Webster, Inc. announced today that it has acquired Coherex Medical, Inc. a privately held medical device company based in Salt Lake City, Utah focused on the development of the Coherex WaveCrest® Left Atrial Appendage (LAA) Occlusion System. The device is designed to permanently occlude the LAA in high-risk atrial fibrillation (Afib) patients to help reduce the incidence of stroke caused by the migration of blood clots formed in the LAA, which is recognized as the source of blood clots in approximately 90 percent of patients who have Afib.[i]
“The addition of the Coherex WaveCrest® System complements our comprehensive portfolio of therapeutic solutions for patients suffering from atrial fibrillation who not only suffer from reduced quality of life but also face a significantly greater risk of a stroke,” said Shlomi Nachman, Company Group Chairman. "As the exclusive distributor of this system in regions outside of the U.S. since 2013, we are confident it will be well-differentiated in the market.”
Afib is associated with a five-fold increased risk of stroke and prevention in patients with Afib represents a large unmet clinical need. This acquisition reinforces the company's commitment to providing innovative, minimally invasive therapies for the treatment of Afib, which affects over 3 million patients in the United States and 20 million worldwide.
"The Coherex WaveCrest® System offers substantial benefits for patients with atrial fibrillation who are at high risk for stroke,
particularly for those who are contraindicated to anticoagulants and would therefore, be unprotected from the risk of cardio embolism," said Alex Martin, President and CEO, Coherex Medical. "We are excited that this technology will be coupled with Biosense Webster’s market leading therapies and look forward to bringing this innovative solution to more patients worldwide who stand to benefit from reduced risk of stroke.”
The Coherex WaveCrest® LAA occlusion system received CE Mark in September 2013. It is not available for investigational use or commercial distribution in the U.S. at this time.
About Biosense Webster Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. Biosense Webster is part of the Johnson & Johnson Family of Companies. More information can be found at www.biosensewebster.com.
About Left Atrial Appendage (LAA) Closure The LAA is a muscular pouch connected to the upper left chamber of the heart, or left atrium. In a normally functioning heart, the heart contracts with each heartbeat and the blood in the left atrium and LAA is squeezed out into the bottom left chamber of the heart, or left ventricle. In patients with Afib, the fast and chaotic impulses do not give the atria time to contract and/or effectively squeeze blood into the ventricles. Because the LAA is a little pouch, blood collects there and can form clots in the LAA and atria. When blood clots are pumped out of the heart, they can cause a stroke. The LAA is recognized as the source of blood clots in approximately 90 percent of patients who have Afib. To prevent harmful blood clots from leaving the LAA and entering the blood stream, patients with non-valvular Afib can undergo a minimally invasive catheter-based procedure called LAA closure. During this procedure, a closure device seals the entrance of the LAA, thus reducing the ability for blood clots to travel through the body and increase stroke risk. Afib is associated with a five-fold increased risk of stroke and prevention in patients with Afib represents a large unmet clinical need.
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Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to the acquisition of Coherex Medical, Inc. and development of the Coherex WaveCrest® System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges related to integrating the products and operations of Coherex Medical, Inc., as well as the ability to ensure continued performance or market growth of Coherex Medical, Inc.’s products; the potential that the expected benefits and opportunities related to the transaction may not be realized or may take longer to realize than expected; uncertainty of commercial success for the product; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and global health care reforms and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Biosense Webster, Inc. and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.
[i] Parekh A, Jaladi R, Sharma S, Van Decker WA, Ezekowitz MD. Images in cardiovascular medicine. The case of a disappearing left atrial appendage thrombus: Direct visualization of left atrial thrombus migration, captured by echocardiography, in a patient with atrial fibrillation, resulting in a stroke. Circulation. 2006;114:e513–4.