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news.St Jude Medical has received the FDA clearance and European CE Mark approval for new delivery tools designed to give physicians greater control and precision when placing cardiac pacing leads in heart anatomy.
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The CPS Duo stylet and guidewire system and the CPS Courier guidewire received FDA clearance and CE Mark approvals, and the Mond stylet received FDA clearance. The tools are designed to place leads in precise positions that, while optimal for delivering pacing therapy, can be difficult to access.
The CPS Courier guidewire and the CPS Duo system are part of the St Jude Medical portfolio of heart failure lead delivery tools (used when implanting cardiac resynchronization therapy, or CRT, systems) that help physicians navigate the left side of the heart. According to the company, the CPS Duo system gives physicians a two-in-one tool that is designed to reduce exchanges between the stylet and guidewire, thereby simplifying complex procedures and potentially saving valuable clinic time.
Eric Fain, president of St Jude Medical Cardiac Rhythm Management Division, said: “With these new products, we are putting tools into our physicians’ hands that give them more control by enabling them to get the lead to a targeted location in the heart more efficiently, with as few limitations as possible, so that patients are able to receive the best pacing therapy for their individual conditions.”