figure 3 figure 4 esa valved cannula system designed to ... states/files...new esa valved cannula...

New ESA valved cannula retention performance comparative study and test results.

– Bausch + Lomb ESA valved titanium cannula incorporate a novel shaft retention feature, with a series of raised textured ribs near the hub, specifically designed for better wound retention performance.

– Laboratory test results show an improvement in wound retention performance using the ESA valved titanium cannula compared with EdgePlus (Alcon) stainless steel cannula [3].

– Retention force was also slightly greater than the retention performance of the current Bausch + Lomb ESA non-valved polyimide cannulas.

– ESA valved cannula provide approximately 3 times greater

wound retention performance (retention force, g) than 23G and 25G EdgePlus valved trocar cannula (new 23G ESA valved cannula retention force = 157.4 g vs. 47.92 g for 23G EdgePlus cannula; 25G ESA valved cannula retention force = 153.6 g vs. 52.26 g for 25G EdgePlus cannula).

– The 23G ESA valved titanium cannula retention force was on average slightly greater than the former Bausch + Lomb 23G non-valved polyimide cannula.

Figures 3 and 4 illustrate comparative retention force results for Bausch + Lomb ESA valved cannula, Bausch + Lomb non-valved cannula and EdgePlus (Alcon) valved cannula assemblies for two different gauges (23- and 25-gauge).

References1 ESA valved cannula infusion flow rate comparison and test results. Data on file, Bausch + Lomb. 2 Dimalanta RC, Ray A, Abulon DJKA, Buboltz DC. A closed surgical system with valved trocar cannulas during simulated vitrectomy. Poster presentation at ARVO annual meeting 2012;abstra #D972. 3 ESA valved cannula wound retention performance, comparison and test results. Data on file, Bausch + Lomb.

Bausch + Lomb is a trademarks of Bausch & Lomb Incorporated or its affiliates. All other product/brand names are trademarks of their respective owners.© Bausch & Lomb Incorporated. SUR/SPC/13/030

SU6928(1)

ESA valved cannulas are incorporated into the Bausch + Lomb range of procedure packs.

SKU Label

BL5223V 23G Posterior Vitrectomy Pack with Valves

BL5223WV 23G Posterior Vitrectomy Pack with Valves and Wide Field Illuminator

BL5225V 25G Posterior Vitrectomy Pack with Valves

BL5225WV 25G Posterior Vitrectomy Pack with Valves and Wide Field Illuminator

BL5323V 23G Combined Vitrectomy Pack With Valves

BL5323WV 23G Combined Vitrectomy Vitrectomy Pack with Valves and Wide Field Illuminator

BL5325V 25G Combined Vitrectomy Pack With Valves

BL5325WV 25G Combined Vitrectomy Vitrectomy Pack with Valves and Wide Field Illuminator

BL5423V 23G Posterior Vitrectomy Pack with Valves and AFI

BL5423WV 23G Posterior Vitrectomy Pack with Valves, AFI and Wide Field Illuminator

BL5425V 25G Posterior Vitrectomy Pack with Valves and AFI

BL5425WV 25G Posterior Vitrectomy Pack with Valves, AFI and Wide Field Illuminator

BL5523V 23G Combined Vitrectomy Pack With Valves and AFI

BL5523WV 23G Combined Vitrectomy Pack with Valves, AFI and Wide Field Illuminator

BL5525V 25G Combined Vitrectomy Pack With Valves and AFI

BL5525WV 25G Combined Vitrectomy Pack with Valves, AFI and Wide Field Illuminator

BL5281 23G ESA Kit-valved 6/BX

BL5282 25G ESA Kit-valved 6/BX

BL5283 23G singleTROCAR-valved 6/BX

BL5285 25G singleTROCAR-valved 6/BX

BL5284 23G replacement valves 6/BX

BL5286 25G replacement valves 6/BX

Availability Information

Greater wound retention performance compared with EdgePlus valved cannula

Mean 153.6 g vs. 140.3 g, respectively, P=0.111.Mean 157.4 g vs. 140.8 g, respectively, statistically significant difference, P=0.050.

B+L non-valved 23G VS B+L valved 23G Infusion Flow

Pressure (mmHg)

155

10

15

20

25

30

35

20 25 30 35 40 45 50 55

Flow

Rat

e (m

l/min

)


Pressure (mmHg)

0

5

10

15

20

25

20 25 30 35 40 45 50 55

Flow

Rat

e (m

l/ m

in)

B+L 23G valvedB+L 23G non-valved B+L 25G valvedB+L 25G non-valved

Histogram of new 23G cannula Retention Force.Current 23G cannula, Alcon 23G VS B+L 23G cannula Retention Force

Retention Force (grams)

00

10

20

30

40

50

60

0

10

20

30

40

50

60

50 100 150 200

% d

istrib

utio

n

Alcon 23G can Retention Force (grams)

Mean Std Dev N

157.4 27.20 30

140.8 36.00 30

47.92 18.96 30

Current 23G can Retention Force (grams)

NEW 23G can Retention Force (grams)



0

10

20

30

40

50

60

70

80

70

80

0

10

20

30

40

50

60

40 80 120 160 200

% d

istrib

utio

n


Mean Std Dev N

153.6 27.67 30

140.3 35.32 30

52.26 10.87 30




Pressure (mmHg)

155

10

15

20

25

30

35

20 25 30 35 40 45 50 55

Flow

Rat

e (m

l/min

)


Pressure (mmHg)

0

5

10

15

20

25

20 25 30 35 40 45 50 55

Flow

Rat

e (m

l/ m

in)




00

10

20

30

40

50

60

0

10

20

30

40

50

60

50 100 150 200

% d

istrib

utio

n


Mean Std Dev N

157.4 27.20 30

140.8 36.00 30

47.92 18.96 30





0

10

20

30

40

50

60

70

80

70

80

0

10

20

30

40

50

60

40 80 120 160 200

% d

istrib

utio

n


Mean Std Dev N

153.6 27.67 30

140.3 35.32 30

52.26 10.87 30



Figure 3 Figure 4 ESA valved cannula system designed to enhance surgeon control

Bausch + Lomb’s high performance Entry Site Alignment (ESA) valved cannula system provides a secure and stable environment for IOP maintenance and procedural versatility.

“Minimal force is required to insert the valved cannula into the eye; the insertion force is similar to that required using other valved one-step systems. I prefer insertion with an oblique angle, which provides for a better wound seal”

Kevin J Blinder, MD, Retina Specialist, The Retina Institute, Washington University, United States.

“The textured hub of the ESA valved cannula provides good fixation, with reliable wound retention. Inserting and removing soft tip instruments through the ESA silicone valves during surgery is straightforward. Valved cannulas eliminate the need for plugs, which simplifies the procedure.”

Asheesh Tewari, MD, Retina Specialist, Kresge Eye Institute,Detroit, MI, United States.

– A long taper tip creates a slit wound design and better wound sealing.

– Minimal insertion force is required to insert the new valved cannula – trocar system into the eye.

– Titanium cannula incorporates a textured shaft for improved stability and vitrectomy manoeuvre.

– Improved retention properties compared to the old ESA system– Optimized wound construction and cannula retention, reducing

the need for sutures.

Easy insertion and optimized wound construction

Enhanced wound retention properties

“The infusion flow rate using the ESA valved cannulas is definitely more responsive, providing better fluidics and allowing improved vitrectomy performance.”

Bruce Robert Saran, MD, Retina Specialist, Chester County Eye Care Associates, West Chester, PA, United States.

“The positioning of the valve on the outside of the cannula allows greater surgeon flexibility, while the transparent design enhanced illumination for instrument exchanges in dim light.”

Asheesh Tewari, MD, Retina Specialist, Kresge Eye Institute, Detroit, MI, United States.

Higher achievable infusion flow rates

– Infusion cannula with tapered design that mechanically confirms retention and provides for substantially higher (>50%) achievable infusion flow rates compared with non-valved polyimide cannulas, facilitating improved IOP control;

– A secure closed fluidic system, minimising both IOP fluctuations during instrument exchange and risk of adverse outcomes caused by heightened intraoperative IOP changes.

– Self-sealing valves that are surgeon removable, allow vent-leakage at 60 mmHg infusion pressure (egress as required under certain intraoperative situations).

– Designed for use with soft tip instruments.– Translucent valves to assist instrument exchange in diminished

light.

Self sealing, vented valves that are surgeon removable

ESA valved cannula infusion flow rate comparative study and test results.

– Test results from a comparative infusion flow rate study show greater flow rates than ESA non-valved infusion cannula assembly [1].

– Higher potential infusion flow rate performance using valved cannulas during closed-system vitrectomy facilitates more stable IOP control irrespective of aspiration rate, improving fluidic stability with minimal fluid leakage during instrument exchange[2].

– The inner diameter of the locking infusion line has been enlarged to improve overall intraocular pressure (IOP) maintenance.

– Assessed across a range of bottle pressures (from 20 mmHg to 50 mmHg), the ESA valved infusion cannula assembly demonstrated a higher achieved infusion flow rate for the 23G cannula and the 25G assembly compared with ESA non-valved cannula of the same gauge (Figures 1,2).

Higher potential infusion flow rates, for greater fluidic stability

Figure 1Infusion flow rates using 23G valved and non-valved cannulas

Figure 2Infusion flow rates using 25G valved and non-valved cannulas


Pressure (mmHg)

155

10

15

20

25

30

35

20 25 30 35 40 45 50 55

Flow

Rat

e (m

l/min

)


Pressure (mmHg)

0

5

10

15

20

25

20 25 30 35 40 45 50 55

Flow

Rat

e (m

l/ m

in)




00

10

20

30

40

50

60

0

10

20

30

40

50

60

50 100 150 200

% d

istrib

utio

n


Mean Std Dev N

157.4 27.20 30

140.8 36.00 30

47.92 18.96 30





0

10

20

30

40

50

60

70

80

70

80

0

10

20

30

40

50

60

40 80 120 160 200

% d

istrib

utio

n


Mean Std Dev N

153.6 27.67 30

140.3 35.32 30

52.26 10.87 30




Pressure (mmHg)

155

10

15

20

25

30

35

20 25 30 35 40 45 50 55

Flow

Rat

e (m

l/min

)


Pressure (mmHg)

0

5

10

15

20

25

20 25 30 35 40 45 50 55

Flow

Rat

e (m

l/ m

in)




00

10

20

30

40

50

60

0

10

20

30

40

50

60

50 100 150 200

% d

istrib

utio

n


Mean Std Dev N

157.4 27.20 30

140.8 36.00 30

47.92 18.96 30





0

10

20

30

40

50

60

70

80

70

80

0

10

20

30

40

50

60

40 80 120 160 200

% d

istrib

utio

n


Mean Std Dev N

153.6 27.67 30

140.3 35.32 30

52.26 10.87 30



figure 3 figure 4 esa valved cannula system designed to ... states/files...new esa valved cannula...

Documents