Progel™ Pleural Air Leak Sealant , the only product FDA approved as an adjunct for treatment of pleural air leaks during open thoracotomy, forms a highly flexible hydrogel specifically designed for use on the lung.

Adherence1

  • Flows easily into the tissue’s intricate anatomy
  • Cross-linking begins at spray tip and continues at the tissue site
  • Direct contact with the visceral pleura for strength in adherence

HSA: Optimal Contact and Adherence

Human Serum Albumin (HSA) is a large protein molecule that provides Progel™ PALS with its adhesive strength.

Strength1

  • Begins to form a hydrogel within 15-30 seconds
  • Reaches adequate  strength within 2 minutes
  • Supports seal strength during critical postoperative healing period

PEG: Strength & Flexibility

The proprietary Polyethylene Glycol (PEG) used in Progel™ PALS formulation is a non-toxic, non-immunogenic molecule3 which lends the hydrogel its ability to stretch.

Flexibility1

  • Engineered to be flexible
  • Able to expand and contract during respiration
  • Provides elasticity with a strong seal.

Cost Efficient for Facilities by Reducing Length of Stay

Shown to reduce the length of hospitalization by 1.9 mean days, potentially minimizing associated complication and cost-of-care.3

1. Davol Inc. In Vitro Bench Testing. Data on File. Preclinical data may not correlate to outcomes in humans.
2. Allen, Mark S. et al, “Prospective Randomized Study Evaluating a Biodegradable Polymeric Sealant for Sealing Intraoperative Air Leaks That Occur During Pulmonary Resection” Annals of Thoracic Surgery 2004; 77:1792-1801. Pivotal study. Data on file.
3. Davol Inc. Comprehensive Biocompatibility Study. Data on File. Preclinical data may not correlate to outcomes in humans.

Ordering Information

    • PGPS002
    • 4/cs.
    • Progel™ Pleural Air Leak Sealant Kit - 4ml (sterile), Includes (1) Applicator Kit with (2) Applicator Spray Tips
    • PGEN005-11
    • 4/cs.
    • Progel™ PALS Extended Applicator Spray Tip 29cm, Includes (1) Extended Applicator Spray Tip
    • PGEN005-06
    • 4/cs.
    • Progel™ PALS Extended Applicator Spray Tip 16cm, Includes (1) Extended Applicator Spray Tip
    • PGST009
    • 10/cs.
    • Progel™ PALS Applicator Spray Tips, Includes (2) Applicator Spray Tips

Accessories

  • Progel™ PALS Extended Spray Tip
    • PGEN005-11
    • 4/cs.
    • Progel™ PALS Extended Applicator Spray Tip 29cm, Includes (1) Extended Applicator Spray Tip
  • Progel™ PALS Extended Spray Tip
    • PGEN005-06
    • 4/cs.
    • Progel™ PALS Extended Applicator Spray Tip 16cm, Includes (1) Extended Applicator Spray Tip
  • Progel™ PALS Applicator Spray Tip
    • PGST009
    • 10/cs.
    • Progel™ PALS Applicator Spray Tips, Includes (2) Applicator Spray Tips

Intended Use / Indications For Use

Progel™ Pleural Air Leak Sealant (PALS) is a single use device intended for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (≥ _2 mm) incurred during open resection of lung parenchyma.

Contraindications

  • Do not use Progel™ PALS in patients who have a history of an allergic reaction to Human Serum Albumin or other device components.
  • Do not use Progel™ PALS in patients who may have insufficient renal capacity for clearance of the Progel™ PALS polyethylene glycol load.
  • Do not apply Progel™ PALS on open or closed defects of main stem or lobar bronchi due to a possible increase in the incidence of broncho-pleural fistulae, including patients undergoing pneumonectomy, any sleeve resection or bronchoplasty.
  • Do not apply ProgelPALS on oxidized regenerated cellulose, absorbable gelatin sponges or any other surface other than visceral pleura as adherence and intended outcome may be compromised.
  • Do not use more than 30 ml of Progel™ PALS per patient.

Warnings
Progel™ PALS safety and effectiveness was evaluated in 5 patients with FEV1 ≤ 40%, providing limited data about Progel™ PALS use in patients with FEV1 ≤ 40%. For patients with preop FEV1 ≤  or > 40%, mean (median) chest tube placement duration for patients with FEV1 ≤ 40% was 8.3 (7.0) days for Progel™ PALS and 5.8 (4.5) days for Control subjects; for patients with FEV1 > 40%, the mean (median) chest tube placement duration was 6.8 (5.0) days for Progel™ PALS and 6.2 (5.5) days for the Control cohort.

Precautions
The safety and effectiveness of Progel™ PALS has not been established in patients with the following conditions:

  • Less than 18 years of age, pregnant or nursing women.
  • Contaminated or dirty pulmonary resection cases.
  • The presence of an active infection.
  • In the presence of other sealants, hemostatic devices or products other than sutures and staples used in standard visceral pleural closure.
  • Visceral pleural air leak due to spontaneous pneumothorax, any non-resective pulmonary tissue trauma, or malignancy as well as congenital or acquired functional or anatomic defect.
  • Patients receiving Progel™ PALS in more than one application session (surgery) before and/or after resorption of Progel™ PALS that was applied in any previous surgical session.

In any area or tissue other than the visceral pleural surface as indicated.

Adverse Events
There were 3 subjects in the Progel™ PALS group with AEs that were considered by the investigator to be possibly or probably related to the device. The AEs reported were: chest pain, constipation, gastroesophageal reflux, nausea, cough, dyspnea, pneumothorax, and subcutaneous emphysema. All were reported as a single occurrence in the Progel™ PALS group. Two of the AEs, dyspnea and chest pain, were reported as “severe” and “serious,” respectively and occurred in the same subject. All others were reported as mild or moderate.

In a clinical trial there were reports of renal dysfunction, urinary system disorders and deaths within the study population. None of these have been confirmed to be associated with Progel™ PALS. The details of these clinical trial adverse events can be reviewed in the IFU supplied with the product and also available at www.davol.com.

Caution: Federal (USA) law restricts this device to sale by or on order of a licensed physician or properly licensed practitioner.