Boston Scientific Gains FDA Approval for New Catheter

Adding to its growing list of electrophysiology (EP) products, Boston Scientific (NYSE: BSX  ) 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.

link


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2604615, ~/Articles/ArticleHandler.aspx, 9/1/2014 10:55:13 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement