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The Pre-B. Seal Lung Biopsy Plug System is indicated for sealing pleural punctures to reduce the risk of pneumothoraces (air leaks) associated with percutaneous, transthoracic needle lung biopsies and to provide accuracy in marking a biopsy needle entry site for visualization during surgical resection. The Pre-B. Seal Lung Biopsy Plug System is indicated for use in adult patients (age > 21 years).

The Pre-B. Seal Lung Biopsy System is a sterile single-use medical device comprised of the following components: - Prefilled Hydrogel Syringe - Delivery System 15cm length, 16cm length, 20cm length The model numbers are: - Pre-B. Seal Lung Biopsy Plug System 15cm (Model # FG0001) - Pre-B. Seal Lung Biopsy Plug System 16cm (Model # FG0002) - Pre-B. Seal Lung Biopsy Plug System 20cm (Model # FG0003) The Delivery System is comprised of an introducer pre-assembled with a delivery needle, with depth markings on the external surface of the introducer. The delivery needle and introducer are both constructed of stainless steel. A pebax white depth marker ball sits on the introducer and may be used in addition to the markings as a depth indicator. The delivery system is ethylene oxide (EO) sterilized and is patient contacting (≤ 24 hours (includes transient contact). The prefilled syringe contains a sealant (hydrogel) which acts as an absorbable lung biopsy plug. The hydrogel plug consists of gelatin, saline and hyaluronic acid. The plug is provided in ready to use configuration within a prefilled hydrogel syringe. The hydrogel is biodegradable. The prefilled hydrogel is steam sterilized. The hydrogel is patient contact (> 30 days (i.e., permanent)) The syringe is indirect patient contacting. These components have been designed for use during a CT-guided transthoracic lung biopsy procedure. The syringe is attached to the delivery system and then purged using a standard hypodermic purging technique outside of the patient. The distance from the skin to the pleura surface is measured using CT imaging, and using this information, the device is advanced to the intended deployment location within the lung under CT guidance. The hydrogel plug is deployed via the prefilled syringe below the surface of the lung through the delivery system. The hydrogel plug creates a seal around the delivery system through which a biopsy is conducted. When the biopsy is complete, the delivery system is withdrawn, and the hydrogel plug remains in place to fill the void and marks the biopsy needle entry site for visualization during surgical resection. The hydrogel plug is biodegradable and resorbs over approximately 49 days.