1. Introduction
A tracheostomy is a common surgical procedure performed
on intubated patients to transition mechanically ventilated
patients from an endotracheal tube to a tracheotomy tube.
A percutaneous dilatational tracheostomy (PDT) is generally
accepted as a clinically safe procedure with an intra-
operative complication rate of 5%-19%. A recent meta-
analysis of all PDT-related deaths showed the most
common intra-procedural causes of death were loss of
airway (accidental extubation by manipulation of the ETT)
and pneumothorax, proposed to be caused by air trapping
in the lungs due to the occlusion of the trachea by the
bronchoscope and dilators during the procedure.
This poster describes a prototype adaptable laryngeal mask
(LM) device, GemView-LM, designed to improve patient
ventilation during PDT and lower procedural complications,
while being adaptable to an in situ ETT.
Medical Need
AAMC Center for Workforce Studies - The Complexities of Physician Supply and Demand: Projections through 2025
Competitors
GemView-LM: A Modified Laryngeal Mask for Percutaneous Tracheostomies
CG Cover, SM Vignes, NR Chedid, SM Kleinpeter, J Palomino1
Crescentium LLC (New Orleans, LA); 1 Tulane University School of Medicine New Orleans, LA
Device Design
Proposed Procedure
Proof of Concept Data
Market
• Target market - $162 Million – PDT, Laryngeal Edema,
Difficult Airway.
• The GemView-LM has the potential to be used in all three
cases.
Cost Saving Capability
Posterior (A), anterior (B), and lateral (C) view of the GemView-LM
composing of the laryngeal cuff designed to fit within the
oropharynx, a viewing tube which will house a fiberoptic
bronchoscope, and the endotracheal tube sheath designed to fit
over an in situ endotracheal tube.
Acknowledgements
Current Validation and Funding
• LA Board of Regents Opt-In Category II grant ($20,000)
• 3rd Place – Johns Hopkins Business Plan Competition –
Medical Technology Graduate Track ($3,000)
• Tulane Technology Transfer IDEA grant ($20,000)
• 2nd Place – Tulane Business Model Competition ($13,000)
• Finalists in the Southeastern Bio Business Plan Competition
A B C
AdaptableUnobstructed Ventilation Single Physician
Traditional PDT
device
FDA Specs
Class: Class I - no premarket
approval
Pathway: Traditional 510(k) class I
device
Predicate: LMA Proseal (provides
an established 510 (k)
pathway)
“Aging population may drive demand sharply for specialties that
predominantly serve the elderly.”
“Even a modest increase in physician productivity could do more to
alleviate the gap between supply and demand more than any other
supply-side change.”
† PDT - Bedside procedure performed in ICU with GemView
**LOS - Length of Stay due to complication (conservative)
¥ Fixed surgeon fee
* ST – Surgical Tracheostomy is another method of
tracheostomy that is losing favorability among hospital
institutions due to expenses and complication rate; however,
not all hospitals have switched over due to the current
complications associated with the PDT procedure.
Market Drivers
 Rising respiratory disease burden due to aging population.
 Personnel shortage leads to demand for devices to compensate.
 Increased number of surgical procedures  higher usage of
anesthesia devices.
 Market preference for single use devices.
Area of Saving Single Physician
Savings of PDT†
vs ST*
Reduced
LOS/Day in
ICU*
Amount Saved $815¥ $851 $4,000
GemView-LM Insertion
& Use Video
A - Disconnect ETT from ventilator, then insert
GemView-LM over ETT.
B – Immediately reconnect ventilation once the
proximal tip of ETT passes through the
GemView-LM.
C – Use the rigid viewing tube as a handle to
insert the GemView into the oropharynx, use
the depth markers to confirm correct
placement. Inflate the GemView balloon.
D – Insert a fiberoptic bronchoscope into the
viewing tube, adjust ETT depth dependent
upon preference to remove the ETT balloon
away from the incision site.
E – Perform surgical portions of PDT procedure.
F – Confirm correct placement of tracheostomy
tube. Retract as single unit.