Boston Scientific Gains FDA Approval for New Catheter
Adding to its growing list of electrophysiology (EP) products, Boston Scientific has gained approval from the Food and Drug Administration for its IntellaTip MiFi XP catheter, the company announced today.
The new catheter is designed to assist physicians in performing catheter ablation procedures, a process in which "localized electrical energy is delivered into the heart tissue and is aimed at restoring the continuous normal rhythm," Boston Scientific said.
In addition to the FDA's approval of its new catheter, Boston Scientific also announced it had received 510(k) clearance for another EP tool, the Zurpac 8.5F steerable sheath, which allows doctors to gain access to the heart, facilitating placement of catheters for a number of procedures, according to the company's statement.
Also known as "premarket notification," section 510(k) of the Food, Drug and Cosmetic Act requires companies intending to market a new or "significantly changed or modified" medical device to apply with the FDA at least 90 days in advance of introducing the product to the marketplace.
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