Haemonetics says FDA clears vascular closure device

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. (REUTERS/Andrew Kelly/File Photo)


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Oct 19 — Haemonetics said on Monday the US ​Food and Drug Administration approved its device designed to seal arterial openings ‌created during minimally invasive heart and vascular procedures.

Shares ⁠of the medical ​technology company rose ⁠about 1.2% in extended trading.

• The ‌device, PerQseal ‌Elite, uses a fully absorbable patch that ⁠dissolves over ⁠time and does not leave a permanent implant in the body

• Haemonetics obtained the technology as part of its January 2026 acquisition of Ireland-based Vivasure ‌Medical

• FDA's approval covers ​use of the device with large access sheaths commonly used in structural heart and endovascular procedures

• Haemonetics said physicians can confirm if bleeding has stopped without losing guidewire access during ​the procedure

• The company also said ‌it will ‌present ⁠additional clinical data at the Transcatheter Cardiovascular Therapeutics conference later this month

• Haemonetics sells blood collection, blood management and interventional ‌medical products, including ​vascular closure technologies ‌used in cardiovascular ⁠procedures

(Reporting ​by Sahil Pandey in Bengaluru; Editing by Diti ​Pujara)

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