REVEEL GENTLE, FAST and EASY Laparoscopic Retraction PRODUCT OVERVIEW for PUSULA MEDICAL...

REVEELGENTLE, FAST and EASY Laparoscopic Retraction

PRODUCT OVERVIEWfor

PUSULA MEDICAL

1CONFIDENTIAL - RETRACTION LIMITED

Why something better?

CONFIDENTIAL - RETRACTION LIMITED 2

Obesity: a global problem


400 million people across the world are considered obese

700 million people are expected to be obese by 2015

Obese Population in the World (2009): Percentage by Region [3.1]

[3.1] Bariatric (Obesity) Surgical Devices - A US & European Market Report 07/09Global Industry Analysis, Inc., 5645 Silver Creek Calley Road, San Jose, CA 95138

Liver retraction: large opportunity


(1) Susan Cox, American Society for Metabolic and Bariatric Surgery (ASMBS) direct communication via email, dated March 29, 2010(3) Marketing Initiatives Clinical Plus ICD-9 Procedure Data Projections (based on all payer data)(4) Bariatric (Obesity) Surgical Devices - A US & European Market Report 07/09

Global Industry Analysis, Inc., 5645 Silver Creek Calley Road, San Jose, CA 95138Calculated by device revenues divided by ASP $1500/procedure to achieve procedure estimates

CAGR ≥ 7%

600,000 proceduresrequire a new solution

Heavy patients require better retractors


• Liver size and weight overwhelm current designs– Larger patients have larger,

heavier livers [5.1]

– Preoperative liver-reducing diets are common

• Obese livers create problems for surgeons– Visualization is poor– Liver slips requiring repositioning

of retractor– Retraction pressure on liver is

increased, causing injury– Procedures are lengthened, made

more complex

[5.1] “Relationship Between Liver Size and Body Size”Frank H. DeLand, M.D. and Wendy A. North, M.I.R.Johns Hopkins Medical Institutions 615 N. Wolfe St., Baltimore, Md. 21205 Division of Nuclear Medicine, The Johns Hopkins Medical Institutions, Baltimore, Maryland. December 1968 Radiology, 91, 1195-1198.

‘It can be seen that as body weight increases, the liver weight increases . . . ’ [5.1]

What is needed?


Current retractors don’t work



Nathanson: dangerous and tedious• Difficult to set up and

requires frequent repositioning

• Can only be used in medial position

[8.1] Nathanson LK,“very large, fatty livers and force being exerted upwards, some damage can occur” [to the liver]. Cook Training Video

• Not suitable for large livers: can injure liver[8.1][8.2]

• Slips constantly• Shape allows liver to hang

in visual field

[8.2] Tamhankar AP, Kelty CJ, Jacob G et al (2011) Retraction-Related Liver Lobe Necrosis After Laparoscopic Gastric Surgery. JSLS 15:117–121


Diamond-Flex: expensive, impossible to clean

• Impossible to clean [9.2]

• Slips, requiring frequent repositioning

• Prone to breakage - components deposited in patient [9.1]

• Reusable but expensive to buy and to repair

• Difficult and slow to set up

[9.1] Diamond flex angled triangular retractor broke [during surgery]; surgeons felt they had retrieved all pieces. A postop x-ray revealed pieces of broken retractor still inside the patient. FDA Adverse Event Report

[9.2] Radionuclide testing conducted under EU CRAFT Research program “Testing and measurement procedure for the validation of the cleaning behaviour of reusable surgical devices” (CLEANTEST) G6ST-CT-2001-50121

Fan Retractors: surgeons say “No!” • Traumatic: fan blades can

damage liver (especially 5mm versions)

• Requires 5mm or 10mm trocar


• Poor rigidity• No traction features


Liver trauma: what the clinical papers say

“Care should be taken to minimize intraoperative liver damage by decreasing the duration of liver retraction or using a gentle retraction method” [11.1]

“Patient died after surgery and the death was attributed to liver infarction caused by retraction using Nathanson” [11.2]

“Liver retraction [pressure] causes abnormal transaminase levels” [11.3]

“Direct mechanical pressure may result in a transient decrease in hepatic blood-flow” [11.4]

[11.1] Kinjo Y, Okabe H, Obama K et al (2011) Elevation of Liver Function Tests After Laparoscopic Gastrectomy Using a Nathanson Liver Retractor. World J Surg 35:2730–2738

[11.2] Tamhankar AP, Kelty CJ, Jacob G et al (2011) Retraction-Related Liver Lobe Necrosis After Laparoscopic Gastric Surgery.JSLS 15:117–121

[11.3] Lohlun JC, Guirguis A, Wise L (2004) Elevated Liver Enzymes Following Open Roux-en-Y Gastric Bypass forMorbid Obesity – Does Timing of Liver Retraction affect the Rise in the Levels of Transaminases? Obes Surg 14:505-508

[11.4] Saranita J, Soto RG, Paoli D (2003) Elevated Liver Enzymes as an Operative Complication of Gastric Bypass Surgery. Obes Surg 13:314-316

The REVEEL Advantage


The REVEEL advantage

Unparalleled exposure• Harp shape conforms to

liver shape• I-Beam prevents

drooping liver

• Better access to upper gut; better visualization of operative site


Exposure: can yours do this?

CONFIDENTIAL - RETRACTION LIMITED14

REVEEL in action


Active traction: stop the crushing!• Radical re-think of retraction:

• NiTi arms – flexible yet rigid• Soft, atraumatic overmold• Braid actively engages tissue

• Gently holds without crushing pressure

• Active traction prevents loss of time and prevents injury due to slippage and pressure



REVEEL CoF = Nathanson CoF X 2

More Friction Less Pressure

Less PressureLess Liver Disruption / Damage

Friction is the secretNathansonREVEEL

Faster and easier• Dilating tip allows rapid

introduction without a trocar

• One-step handle is fast and easy to actuate, set up, and remove

• Effective retraction achieved in 30 to 50 s

• Fast and easy to use


Strong• Strength and rigidity

derived from: • Integral I-beam• Super-elastic arms

• Won’t bend or break in bariatric procedures– 1 kg kimchi:

no problem!– obese liver:

no problem!


A radical re-think of retraction


Key milestonesNon Sterile Demo Units 02/13Sterile Demo Units 04/13Formal US Launch – SAGES 04/13Friction comparison study poster – SAGES 04/13Human study results – CUHK 04/13 [21.1]

Formal EU Launch – EAES 06/13

[21.1] Provisional results of Chinese University Hong Kong’sRandomized Study of REVEEL versus Nathansonin Bariatric and Upper GI procedures


RETRACTION LIMITEDRevealing Solutions in Laparoscopy Surgery


RETRACTION Limited

Revealing Solutions in Laparoscopic Retraction


RETRACTION Limited


REVEEL GENTLE, FAST and EASY Laparoscopic Retraction PRODUCT OVERVIEW for PUSULA MEDICAL...

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