Progel™ Pleural Air Leak Sealant is the only sealant FDA approved and clinically proven to seal air leaks in both open and minimally invasive thoracic surgery2Progel™ is a specialized product designed with a unique combination of strength, flexibility and adherence that allow it to expand and contract with the lung during respiration. In a recent clinical trial of patients undergoing Video-Assisted or Robotic-Assisted lung resection, Progel™ Pleural Air Leak Sealant sealed or reduced 96% of air leaks in the OR2

Designed: 

  • The only sealant specially designed for the lung and its unique characteristics
  • Combines Polyethylene Glycol (PEG) and Human Serum Albumin (HSA) to form a flexible hydrogel
  • Gels at the tissue site, binding directly to the lung for optimal adherence and an airtight seal
  • Strong enough to withstand re-expansion of the lung within 2 minutes of application2,3
  • Highly elastic to allow the lung to expand and contract naturally during respiration
  • The patented Progel™ Spray Tip allows for customized application from a single, easy-to-use device

Indicated:

  • The only sealant approved by the FDA to treat pleural air leaks2
  • Now FDA approved to treat air leaks in open thoracotomy, Video-Assisted and Robotic Assisted Thoracic Surgery2

Clinically Proven: 

  • The only sealant clinically proven to effectively treat air leak complications in both open and minimally invasive thoracic surgery1,2
  • Sealed or reduced 96% of air leaks in the OR in a recent clinical trial of patients undergoing Video-Assisted or Robotic-Assisted lung resection2
  • Reduced inpatient length of hospitalization by an average of 1.9 days in a prospective, randomized clinical trial1

Cost Effective: 

  • As many as 58% of lung surgery patients will have an air leak in the OR1, and more than 15% will develop a persistent air leak after surgery4
  • Identifying and treating air leaks intraoperatively provides the best chance for preventing persistent air leak complications and providing incidental cost-of-care savings5
  • Progel™ Pleural Air Leak Sealant has been shown to effectively seal air leaks during lung surgery, reducing length of hospitalization by 1.9 days on average, potentially minimizing associated complications and providing cost-of-care savings1

 

 

 

 

1.  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.
2.  Progel™ Pleural Air Leak Sealant Instructions for Use. M-00368. Davol Inc. Data on file.
3. Davol Inc. In Vitro Bench Testing. Data on File. In vitro test results may not correlate to clinical performance.
4. Brunelli et al. Predictors of prolonged air leak after pulmonary lobectomy. Ann Thorac Surg 2004; 77: 1205-1210. Based on the reported incidence of prolonged postoperative air leak.
5. Okereke, I, Murthy, SC, Alster, JM, Blackstone, EH, Rice, TW. Characterization and Importance of Air Leak After Lobectomy. Ann Thorac Surg 2005;79:1167-1173.
6. Estimated based on 4Q 2014 sales data and an estimate of 1.2 mL kits per procedure.
 

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 is a single use device intended for application to visceral pleura after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks incurred during 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.

Warnings
Do not apply Progel™ PALS on oxidized regenerated cellulose, absorbable gelatin sponges or any other surface other than visceral pleura as adherence and intended outcome may be compromised.

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.
  • FEV1 ≤ 40% due to small sample size in the clinical study. In the original pivotal study, all 5 Progel™ PALS and 4 Control patients with FEV1 ≤ 40% had post-operative air leak (POAL); whereas in patients with FEV1 > 40%, 59/93 (63.4%) Progel™ PALS and 45/53 (84.9%) Control patients had POAL. See Section 7.9 Effectiveness: Primary Effectiveness Outcome.

Adverse Events
In a pivotal clinical trial 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.

In a subsequent minimally invasive clinical trial there were no device related adverse events or unanticipated adverse events. The majority of AEs reported in this study were mild or moderate in severity. The majority of SAEs were pulmonary and expected events as part of a lung resection surgery. Two patients died during the course of the study, one due to cardiac arrest and another due to multi-system organ failure; neither were device related or unanticipated.

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…