The Only Sealant Indicated
Specifically for Pleural Air leaks
Progel® Pleural Air Leak Sealant is a resorbable hydrogel designed to
seal air leaks incurred during pulmonary surgery. Progel’s biocompatible
formula combines a unique solution of Human Serum Albumin with
Polyethylene Glycol to provide strength, flexibility and unmatched
adherence to visceral pleura.
Specifically Designed for
Thoracic Surgeons
Air leaks are one of the most common complications associated with pulmonary
surgery, and when left untreated can lead to additional complications and
morbidities that extend inpatient hospitalization and increase healthcare costs.
Progel is the only sealant formulated for
applications to the visceral pleura in the
treatment of intraoperative air leaks:
Clinically Proven to Seal Air Leaks and Reduce Length of Stay1
Key Features
•
•
•
Forms a strong, flexible hydrogel within
15-30 seconds of application.
Adheres to visceral pleura to maintain seal
strength over time.
Resorbs within 30 days to promote
natural healing.
Sealant Strength3
Progel® Pleural Air Leak Sealant was evaluated in a prospective,
randomized, controlled multi-center trial and demonstrated significantly
improved clinical outcomes:
Key Endpoints
•
Effectively sealed intraoperative air leaks1
•
Significantly reduced postoperative air leaks1
•
Reduced hospital length of stay by 1.9 days1
•
Minimized associated complications and morbidities1,2
•
Provided incidental cost-of-care savings1,2
Burst Pressure mmHg
150
120
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.)
90
60
30
0
Fibrin
Sealant
Synthetic
Synthetic
Sealant #1 Sealant #2
Progel®
2. Gremmen, Eric et al. Assessment of the Clinical and Economic
Impact of Air Leaks During Post-Operative Pulmonary Surgery.
International Society for Pharmacoeconomics and Outcomes
Research 2010.
3. Campbell, Patrick K., PhD, et al. Evaluation of Absorbable Surgical
Sealants: In vitro Testing. © 2005
Intuitive System Makes Set Up and Application Easy
Patented Progel® Spray Tips
•
Initiates mixing of hydrogel components
•
Allows for variable spray patterns
•
Additional Spray Tips now sold separately
Ergonomic Applicator Design
•
Simple set up in less than 2 minutes
•
Easy-to-use
•
No spray apparatus required
Specialized Chemistry Formulation
•
Gel formation < 30 seconds
•
Flexible high strength seal within 5 minutes
•
Resorption < 30 days*
*Resorption time demonstrated through pre-clinical evaluation testing.
Variable Spray Patterns
STREAM
SPRAY
Minimal pressure applied to applicator
Increasing pressure applied to applicator
Ideal for targeted application along
staple lines or sutures
Manual control for application to
larger tissue surfaces
Extended Applicator Spray Tips**
Progel Extended Spray Tip 11” (29 cm)
Progel Extended Spray Tip 6” (16 cm)
Progel Standard Applicator Spray Tip
**Applicator Spray Tips NOT shown actual size.
See full product labeling for complete Instructions For Use and important safety information.
Clinical & Economic Validation
Annals of Thoracic Surgery 2004; 77:1792-1801
Prospective Randomized Study Evaluating a Biodegradable Polymeric Sealant for Sealing Intraoperative
Air Leaks That Occur During Pulmonary Resection
Mark S. Allen, Douglas E. Wood, Ronald W. Hawkinson, David H. Harpole, Robert J. McKenna, Garrett L. Walsh, Eric Vallieres,
Daniel. L. Miller, Francis C. Nichols, III, W. Roy Smythe and Robert D. Davis.
Key Endpoints (Progel® vs. control):
•
Prospective randomized study evaluating a biodegradable polymeric sealant for
sealing intraoperative air leaks that occur during pulmonary resection
Mark S. Allen, Douglas E. Wood, Ronald W. Hawkinson, David H. Harpole, Robert J.
McKenna, Garrett L. Walsh, Eric Vallieres, Daniel L. Miller, Francis C. Nichols, III, W.
Roy Smythe and Robert D. Davis
Ann Thorac Surg 2004;77:1792-1801
•
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://ats.ctsnetjournals.org/cgi/content/full/77/5/1792
•
61% increase in successfully sealed intraoperative air leaks
21% increase in successfully sealed patients remaining air leak free at 1 month
1.9 days mean reduction in length of stay (1 day median)
Conclusion:
This study demonstrates the effectiveness of Progel®, a biodegradable polymer when used in
adjunct to standard closure methods for sealing significant intraoperative air leaks that develop
from pulmonary surgery. Use of Progel® led to a reduction in POAL, which may have decreased
length of hospitalization.
The Annals of Thoracic Surgery is the official journal of The Society of Thoracic Surgeons and the
Southern Thoracic Surgical Association. Copyright © 2004 by The Society of Thoracic Surgeons.
Print ISSN: 0003-4975; eISSN: 1552-6259.
Downloaded from ats.ctsnetjournals.org by on July 12, 2010
Air Leaks Sealed in the OR1
80%
Total Hospital Charges2
Hospital Stay1
$70K
10
$60K
77%
60%
40%
9.3
days
1.9
days
7.4
days
5
$40K
$30K
$20K
20%
0%
$14,926 reduction
$50K
$10K
16%
Control
Progel®
0
0
Control
Progel
®
Air Leaks
No Air Leaks
Thoracic Surg Clin 20 (2010) 407-411
The Cost of Air Leak: Physicians’ and Patients’ Perspectives
Adam Lackey, MD, John D. Mitchell, MD
Key Points:
T he Cost of A i r Leak:
P hy si ci a ns’ an d
P a t i e nt s’ P e r s p ec t i ves
Adam Lackey, MDa, John D. Mitchell, MDb,*
•
KEYWORDS
Air leak Postoperative complication
Cost Pulmonary resection
FINANCIAL COSTS
The presence of a prolonged air leak increases
length of stay (LOS),2,3,5,10,12,13 and as a result,
the hospital costs associated with the procedure.
In a study designed to estimate hospital costs
associated with PAL, Varela and colleagues2
described 238 subjects undergoing pulmonary
lobectomy over a 3-year period, noting PAL in 23
subjects (9.7%). Subjects remained hospitalized
until cessation of the leak, allowing for chest tube
removal. As a result, the mean LOS for subjects
with a PAL was twice that noted for the non-PAL
cases. The total additional hospital costs attributed to persistent air leak was calculated to be
39,437 V, or roughly $53,000 (using exchange
rate at the time of publication).
The excess hospital costs noted in the Varela
and colleagues2 study resulted exclusively from
the additional inpatient days and pharmacy
charges incurred by the subjects with PAL until
the leak resolved. It is rare that a second surgical
procedure is needed to address the (parenchymal-based) leak; in almost all cases, expectant management is successful. However, the
presence of air leak after pulmonary resection,
particularly if prolonged, has been associated
with an increased incidence of other postoperative complications.2,10,14 These complications,
such as atelectasis, retained secretions, and
empyema, may require additional treatment
leading to increased hospital costs. Depending
on interpretation, these costs may prove problematic in a capitated reimbursement system.
The Centers for Medicare and Medicaid
Services15 has recently initiated a program
denying payment for inpatient services derived
a
Department of Surgery, University of Colorado Denver School of Medicine, 12631 East 17th Avenue, C-302,
Aurora, CO 80045, USA
b
General Thoracic Surgery, Division of Cardiothoracic Surgery, University of Colorado Denver School of
Medicine, 12631 East 17th Avenue, C-310, Aurora, CO 80045, USA
* Corresponding author.
E-mail address: john.mitchell@ucdenver.edu
Thorac Surg Clin 20 (2010) 407–411
doi:10.1016/j.thorsurg.2010.04.004
1547-4127/10/$ – see front matter ª 2010 Elsevier Inc. All rights reserved.
2013-001 2013/02/08
•
•
thoracic.theclinics.com
Despite ongoing technical advances and refinements in surgical technique, the occurrence of
a prolonged parenchymal air leak (PAL) after
pulmonary resection remains an all too frequent
complication. Traditionally depicted as an air leak
persisting beyond 7 days, perhaps the best definition of a prolonged leak is one that delays hospital
discharge; in the modern surgical era, this may be
classified as an air leak persisting beyond 5
days.1,2 The incidence of PAL varies in the literature from 5% to 25%,1–7 and is heavily influenced
by the presence of underlying lung disease7–9 and
the type of lung resection performed.3,5,10 For
example, in the National Emphysema Treatment
Trial, the incidence of prolonged air leak following
lung volume reduction surgery (LVRS) was
approximately 50%, with 12% of subjects having
a persistent leak at 30 days.9 Efforts to reduce
the incidence of PAL using preventative measures
have been inconsistent at best.9,11
The impact, or cost, of a complication such as
prolonged air leak differs for patients and the
involved health care providers. In both cases, the
cost is in part determined by the treatment strategy
chosen to deal with the complication. In this article,
the authors explore the impact of a PAL from the
perspective of physicians and patients, including
factors common to both groups.
Total additional hospital costs attributed to persistent air leaks has been reported to be
roughly $53,000.
Presence of prolonged air leaks have been associated with increased incidences of other
postoperative complications.
Use of Heimlich valve or other ambulatory chest drainage burdens patients with additional
direct and indirect treatment related costs.
Product Codes:
Catalog Number
Quantity
Description
PGPS002
4/cs.
Progel® Pleural Air Leak Sealant (4 ml)
PGST009
10/cs.
Progel Applicator Spray Tips (Pack of 2)
PGEN005-11
4/cs.
Progel® Extended Spray Tip 29 cm (11”)
PGEN005-06
4/cs.
Progel® Extended Spray Tip 16 cm (6”)
q P lease add the Progel® Pleural Air Leak
®
Sealant to my preference card.
q I would like to have the Progel® Pleural
Air Leak Sealant in stock.
q I would like to trial the Progel® Pleural
Air Leak Sealant.
Surgeon’s Signature ________________________________________________________________
Purchase Order Number____________________________________________________________
Catalog Number___________________________________________________________________
Date_________________________________________ Quantity_____________________________
INTENDED USE / INDICATIONS FOR USE
Progel Pleural Air Leak Sealant 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 bronchopleural fistulae, including patients undergoing pneumonectomy, any
sleeve resection or bronchoplasty.
•
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.
•
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.
To learn more, contact your
local Bard representative or
call 1.888.776.4351.
•
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. The details of these clinical trial adverse
events can be reviewed in the IFU supplied with the product and also available
at www.neomend.com.
Caution: Federal (USA) law restricts this device to sale by or on order of a
licensed physician or properly licensed practitioner.
1
Progel Pleural Air Leak Sealant Pre-Market Approval Study. Davol Inc. data on file.
Bard, Davol and Progel are trademarks and/or registered trademarks of C. R. Bard, Inc.
© Copyright 2013, C. R. Bard, Inc. All Rights Reserved.
MMPROSS
Davol Inc. • Subsidiary of C. R. Bard, Inc.
100 Crossings Boulevard • Warwick, RI 02886
1.888.776.4351 • www.neomend.com
Medical Services & Support 1.800.562.0027
M-00056 2013/03/12