Ra Medical Systems krijgt Europees fiat voor verkoop atherectomiesysteem DABRA en fototherapie met Pharos-laser
CARLSBAD, Californië–(BUSINESS WIRE)– Ra Medical Systems, Inc., een niet-beursgenoteerd bedrijf in medische apparatuur dat excimer-laserbehandelingen van cardiovasculaire en dermatologische ziekten ontwikkelt, kondigt aan dat het een CE-markering heeft gekregen voor zijn atherectomiesysteem DABRA met catheter en de excimer-laser Pharos voor de behandeling van psoriasis, vitiligo en andere huidaandoeningen. Dankzij deze goedkeuring mogen de apparaten verkocht worden in de Europese Unie en alle landen die de CE-markering erkennen.
Ziekten aan het perifere vaatstelsel worden gekenmerkt door een vernauwing van de perifere slagaders, wat leidt tot een beperkte bloedtoevoer naar de buik, de benen, armen en het hoofd. Deze aandoeningen lijken wat betreft de oorsprong en wereldwijde verspreiding op ischemische hartklachten. In 2015 beraamde de American Heart Association dat circa 200 miljoen mensen aan ziekten aan het perifere vaatstelsel lijden. Atherectomie is de verwijdering van de plaque uit de aders van mensen met perifere vaatziekten op minimaal invasieve wijze. Het verschilt van angioplastiek, waarbij de plaque niet wordt verwijderd. De methode wordt vaak vergoed omdat atherectomie patiënten veel voordelen biedt. Technavio schreef onlangs dat atherectomie door de gunstige vergoedingsbereidheid tot 2020 jaarlijks toeneemt met 6 procent.
Ra Medical Systems Receives Approval in Europe for DABRA Atherectomy and Pharos Laser Phototherapy Systems |
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CARLSBAD, Calif.–(BUSINESS WIRE)– Ra Medical Systems, Inc., a private medical device company developing excimer laser treatment for cardiovascular and dermatological diseases, announces that it has received CE Marking approval for both the DABRA atherectomy system with catheter, and the Pharos excimer laser to treat psoriasis, vitiligo and other skin diseases. The approval allows the devices to be sold in the European Union and all countries that recognize the CE Mark. Peripheral artery disease (PAD) is a circulatory condition characterized by narrowing of the peripheral arteries resulting in limited blood supply to the stomach, legs, arms, and head. This disease is similar to coronary artery disease in its nature and prevalence worldwide. In 2015 the American Heart Association estimated that about 200 million people have PAD. Atherectomy is the removal of the plaque from the arteries, and it differs from angioplasty in which the plaque is not removed and is a minimally invasive endovascular way to treat patients with PAD. It is well reimbursed because of the benefits to the patients. Technavio recently reported that favorable reimbursement will drive growth of atherectomy by 6% per year through 2020. “This is a major step forward for Ra Medical,” said co-founder and Chief Executive Officer Dean Irwin. “Providing physicians with a safe, easy-to-use device that removes all types of plaque quickly is something my colleagues and I have been working on for over a quarter of a century. CE Marking approval enables physicians around the world to choose the DABRA system that may be safer and more effective for their patients than other treatments. The DABRA’s economics may increase patient access for therapy.” The first DABRA cases in Europe are expected to be performed this year. Ra Medical is currently nearing completion of its US IDE study to support FDA clearance. About Ra Medical Systems Ra Medical Systems was founded in 2002 to commercialize excimer lasers for the treatment of dermatologic and cardiovascular diseases. Its flagship product, Pharos, launched in 2004 and revolutionized the dermatology world with its technology and game-changing business model. Today, Ra Medical Systems continues to make history as it commercializes the DABRA catheter and cardiovascular system in the US. “Safe Harbor” Statement under the Private Securities Litigation Reform Act With the exception of the historical information contained in this release, the matters described here may contain forward-looking statements, including statements that involve risk and uncertainties that may individually or mutually impact the matters herein and cause actual results, events and performance to differ materially. View source version on businesswire.com: http://www.businesswire.com/news/home/20161005005756/en/ Contacts Ra Medical Systems |
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