Pillar® Procedure

Pillar Procedure
®
SOLUTIONS FOR CHRONIC SNORING
Sleep Better. Feel Better. Live Better.
The Scope of the Problem
An estimated 75 million Americans (1 in 4)
suffer from chronic snoring
One in four people suffers from chronic snoring,
which keeps both snorer and bed partner
from getting a good night’s sleep. Many have
tried various snoring products, such as those
advertised on TV, and are often left frustrated.
More than 30,000 patients worldwide
have been treated with the Pillar Procedure.
It is safe, effective, and minimally invasive,
allowing physicians to restore a good night’s
sleep to more patients than ever before.
The Pillar® Procedure
The minimally invasive palatal solution
for chronic snoring.
Patient benefits
»In-office procedure that takes approximately 20 minutes
»Minimally invasive
»Requires only local anesthetic
»Minimal pain and discomfort
»Patients typically resume normal diet and activities the same day
The Pillar® Procedure
More than 30,000 patients treated worldwide
The procedure
Unique technology
»3 tiny Pillar implants (see illustration
at the right for actual size) placed into
the muscle of the soft palate
THE IMPLANTS
»Implants are placed at the junction of
the hard and soft palate, 2 mm apart
»Polyethylene terephthalate (PET)
»18 mm in length and 2 mm
in diameter
›A linear, aromatic polyester first
manufactured by Dupont® in the 1940s
›Used for implantable sutures,
surgical mesh, vascular grafts and
other internal applications
Hard palate/soft palate
junction
Target zone
2
Pillar Implant (Actual size)
›Demonstrated continuing efficacy
with minimal complications
Fiber Detail of Pillar Implant
Why it works
MRI image viewed end-on (nine months post-procedure), demonstrating tissue encapsulation and cross linking of Pillar Implants
OVER TIME*
»Implants add structural support and
stiffen the soft palate
»Implant surface texture induces body’s
natural fibrotic response
»Tissue in-growth
›Anchors the implant
›Encapsulates and connects the
3 implants
›Prevents relaxed palate from
stretching and flapping during sleep
*Some patients report a noticeable improvement within weeks,
while others may take up to three months to realize the full
benefit of the Pillar® Procedure.
Oropharynx
2 mm
Skeletal muscle
Paired skeletal muscle
Clinical Results
Long-term effectiveness, high patient
and partner satisfaction
Snoring Intensity
Bed Partner Satisfaction
»Clinical trials show 67.7% of patients reduced their
VAS greater than 50%1
»Bed partner satisfaction at 90%5
Quality of Life (QOL)/
Daytime Sleepiness
»Patients experienced a significant improvement in
quality of life (QOL) and daytime sleepiness (ESS) 2, 3, 4
Long-Term Results
»Patient satisfaction at 80%; 53.2% of patients
had reduced their VAS greater than 50%
at 18 months.3
Comparing Treatment Options
Pillar, your minimally invasive palatal treatment of choice
PHYSICIAN EXPERIENCE
Pillar®
RF Ablation
Sclerotherapy
Patient visits
One
Multiple
Multiple
Physician time
Low
Medium
Medium
Specialized capital equipment
No
Yes
No
Pain or discomfort
Low
Medium
Medium
Sedation
Local
Local
Local
≤ 24 hours
≤ 24 hours
≤ 24 hours
Partial extrusion
(2 - 17%)6
Mucosal ulceration
and breakdown7
(22%)
Mucosal ulceration
and breakdown8
(22%)
Palatal support and
tissue fibrosis
Scarring
Scarring
PATIENT TREATMENT EXPERIENCE
Recovery time
PATIENT POTENTIAL SIDE-EFFECTS
Most reported complication
MECHANISM OF ACTION
Mechanism
1 Friedman M, Schalch P, Lin HC, Kakodkar KA, Joseph NJ, Mazloom N. Palatal Implants for the Treatment of Snoring and Obstructive Sleep Apnea/Hypopnea Syndrome.
Otolaryngology-HNS 2008; 138: 209-216.
2 Gillespie MB, et al. Effectiveness of Pillar palatal implants for snoring management. Otolaryngology-Head & Neck Surgery (2009); 140; 363-368.
3 Saylam G, Korkmaz H, Firat H, Tatar EC, Ozdek A, Ardic S. Do palatal implants really reduce snoring in long-term follow-up? Laryngoscope. 2009 May;119(5):1000-4.
4 Steward DL, Huntley TC, Woodson BT, Surdulescu V. Palate implants for obstructive sleep apnea: multi-institution, randomized, placebo-controlled study. Otolaryngology-Head
& Neck Surgery. 2008 Oct; 139(4): 506-10.
5 Romanow J, Catalano P. Initial U.S. Pilot Study: Palatal Implants for the Treatment of Snoring. Otolaryngology-HNS 2006; 134: 551-557.
6 Published clinical studies have demonsrated extrusions at the rate of 2-17%. Procedure expertise may have a result with extrusion rates.
7 Pazos G. et al. Complications of radiofrequency ablation in the treatment of sleep-disordered breathing. Otolaryngol Head Neck Surg. 2001 Nov; 125(5):462-6.
8 Brietzke S. et al. Injection snoreplasty: how to treat snoring without all the pain and expense. Otolaryngol Head Neck Surg. 2001 May; 124(5): 503-10.
This comparative overview is based upon published literature and is not based upon head-to-head clinical comparisons of the Pillar System with any other product or treatment
modality. The physician and patient must determine if the characteristics and features of the Pillar System are right for them.
5
Medtronic ENT
Medtronic USA, Inc.
6743 Southpoint Drive North
Jacksonville, FL 32216
USA
www.MedtronicENT.com
Toll free: (800) 874-5797
Fax: (800) 678-3995
International Telephone Numbers
Adriatic Regional Office 385-1-488-1120
Australia 1800-668-670
Baltic Regional Office 37-1-67560226
Belgium 32-2456-09-09
Canada 1800-217-1617
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Czech Republic 420-2-9657-9580
France 33-470-679-800
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Greece 30-210-67-79-099
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Spain 34-91-625-05-40
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USA 1-904-296-9600
This literature is intended for the exclusive use of physicians. Rx only. © 2009, Medtronic, Inc. Dupont® is a registered trademark of E.I. Du Pont DE Nemours and Company Corporation. Pillar® is a registered trademark of Medtronic, Inc. 890322 09.09 2009-325 Rev. 1
For further information, please call the Medtronic ENT at (800) 874-5797 or (904) 296-9600
You may also consult our website at www.PillarProcedure.com.