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FDA approves first stent in 17 years

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22.10.2018

FDA has given green light to a new stent type named PK Papyrus, created by Biotronik.It will be used in emergency cases - to treat perforations in the heart's blood vessels.It is the first approval of this kind in the "trifling" period of 17 years.

Perforations in coronary arteries are rare cases that may occur during percutaneous interventions, when stents undergo insertion through a catheter in order to expand narrowed vessels and increase the blood flow to the heart. Such types of damage results in leakages into the heart-surrounding area.In order to stop the leaking, the Biotronik's device - namely an ultrathin and expandable through a balloon-based method coronary stem system - becomes inserted under a procedure bearing similarities to the one applied to standard stents.Its polyurethane membrane provides a physical barrier through sealing a perforation from the inside of the artery, thus making it possible to avoid the need to perform an open-heart surgery.

While Marlou Janssen - who manages Biotronik - is aware of the fact that perforations are very rare, he believes that doctors need to be fully prepared for such emergency situations.

Offered in 17 sizes, PK Papyrus previously received a CE mark - in 2013.Biotronik is planning to make the system available to U.S.-based doctors the next year.

Source: fiercebiotech.com

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