Specifically Designed for Thoracic Surgeons A

Proudly distributed in the United Kingdom and Ireland by Healthcare 21
A Sealant Indicated for Pleural Air Leaks
Progel® Platinum Surgical Sealant is a resorbable hydrogel designed to seal
air leaks incurred during pulmonary surgery. Progel® Platinum biocompatible
formula combines a unique solution of recombinant Human Albumin (rHA)
with Polyethylene Glycol to provide strength, flexibility and unmatched
adherence to visceral pleura.
Specifically Designed for
Thoracic Surgeons
Clinically Proven to Seal Air Leaks and Reduce Length of Stay in a
US PMA Approved Product in a Comparative Clinical Study in the
US with Human Serum Albumin.1
Progel® Platinum is the only sealant
chemically engineered for application
to the lung in the treatment of
intraoperative air leaks:
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.
Key Features
•
•
•
Forms a strong, flexible hydrogel
within 15-30 seconds of application.
Adheres to visceral pleura to
maintain seal strength over time.
Key Endpoints
•
Effectively sealed intraoperative air leaks1
Resorbs within 30 days to promote
natural healing.
•
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
Sealant Strength3
The information and data shown is based on a Progel® formulation that includes Human Serum
Albumin (HSA). Progel® Platinum uses recombinant Human Albumin in place of HSA.
150
Burst Pressure mmHg
Progel® Platinum Surgical Sealant was evaluated in a prospective, randomized,
controlled multi-center trial and demonstrated significantly improved clinical
outcomes. This was a US study evaluating Progel® Pleural Air Leak Sealant
(PALS) equivalent to Progel® Platinum Surgical Sealant except that Progel®
PALS includes Human Serum Albumin and Progel® Platinum includes a
recombinant Human Albumin derived from yeast.
120
90
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.)
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):
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)
•
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
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%
Hospital Stay1*
10
77%
60%
$70K
$60K
9.3
days
40%
Total Hospital Charges2
1.9
days
7.4
days
5
$14,926 reduction
$50K
$40K
$30K
$20K
20%
$10K
16%
Control
0%
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 er 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.
*A US study evaluating Progel® Pleural Air Leak Sealant (PALS) equivalent to Progel® Platinum Surgical Sealant except that Progel® PALS
includes Human Serum Albumin and Progel® Platinum includes a recombinant Human Albumin derived from yeast.
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Ordering Information
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Product Codes:
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PGST010
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Qty Description
4/cs.
Progel® Platinum Surgical Sealant (4 ml)
10/box Progel® Applicator Spray Tips
PGEN00516
4/cs.
Progel Extended Applicator Spray Tip (16 cm)
PGEN00529
4/cs.
Progel Extended Applicator Spray Tip (29 cm)
®
®
INTENDED USE / INDICATIONS FOR USE
Progel Platinum Surgical Sealant is a single use device intended for application
to visible air leaks on the visceral pleura after standard visceral pleural closure
techniques have been employed during resection of lung parenchyma.
CONTRAINDICATIONS
• Do not use Progel Platinum in patients who have a history of an allergic reaction
to yeast, rHA or other device components.
• Do not use Progel Platinum in patients who may have insufficient renal capacity
for clearance of the Progel Platinum polyethylene glycol load.
• Do not apply Progel Platinum 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 Progel Platinum 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 Platinum per patient.
WARNINGS
Progel Platinum should be used only as described in these instructions for use.
The Progel Platinum should be refrigerated between 2°C to 8°C (36°F to 46°F).
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Do not freeze. Store the Progel Platinum within the recommended temperature
range. Failure to do so may result in poor product performance. Do not use Progel
Platinum after the expiration date, as sterility or performance may be compromised.
• Inspect the packages before opening. Do not use Progel Platinum after the
“Expiration” date, because sterility or performance may be compromised If
package and/or product integrity have been compromised (i.e., damaged
package seal, or broken glass), do not use or resterilize the contents. Refer to
other ‘precautions’ in this IFU.
PRECAUTIONS
The safety and effectiveness of Progel Platinum 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.
• In any area or tissue other than the visceral pleural surface as indicated.
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IRE 1890 777 444 (e) info@hc21.eu (w) www.hc21.eu
Please consult product labels and inserts for any indications, contraindications, hazards,
warnings, precautions and instructions for use.
Bard, Davol and Progel are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
All other trademarks are the property of the respective legal manufacturer.
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M-00188 2013/03/14