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Interoffice Memorandum - For Internal Use Only

To: Model 5100 File Date: November 11, 2005

cc: From: Vaso Adzich

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Aaron Ingle
Staff Engineer
Matthe-;W--in-6---=;:::-~ II/JI/05

Subject:
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Design input for the Model 5100 ring, holder, and Model 1155 Mitral Valve Caliper
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Purpose

This document is to record the desig'n input obtained from Dr. McCarthy in relation to the model 5100 ring,
holder, and Model 1155. Mitral Valve Caliper.

Background

On October 13, 2005, a discussion was held between Dr. McCarthy, Vaso Adzich, Jinny Lee, Aaron Ingle, and-
Matthew Winston. The discussion was in regards to the model 5100 ring and associated products, and took
place at Tommy Bahama's Restaurant in Newport Beach, CA.

Discussion

Model 5100 Ring: During the discussion, Dr. McCarthy was presented with the following prototype samples:
Metal cores of size 36mm myxomatous rings with (1) a closed "GeoForm type" cross-section, and (2)'
an open triangular cross-section.
Completed 36mm myxomatous rings with (1) a clOsed "GeoForm type" cross-section, and (2) an
open triangular cross-section (constructed with most recent Secant cloth and a silicone rubber band).
Completed rings, with a closed shape, a "GeoForm type" cross-section made of SLA material, the
most recent Secant cloth, and a silicone rubber band, in the following sizes: 26mm, 30mm, 38mm,
and 40mm.
Size 36m holder, with a 25 degree angle and a closed ring attached.
A 40mm Physio ring for size comparison purposes.
Samples of 2-0 Ethibond excel braided polyester suture (wI RB-1 taper 1/2 17mm needle) for needle
penetration/parachuting evaluation.

In comparing the metal cores of the open and closed design, Dr. McCarthy preferred the closed design due to
the reduced cross-section permitted by the design, and explained that he preferred a large sewing margin-to-
metal proportion in the ring.

In the discussion of the ring sizes, Dr. McCarthy felt that a 40mm ring was very large and said that the largest
size he used was a 36mm. However, he felt that if surgeons were requesting larger sizes, then we maywant
to make those sizes available (i.e. 38mm and 40mm).

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EDWARDS CONFIDENTIAL. PROVIDED PURSUANT TO SENATE RULE XXIX.

EW-S-20000168
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Interoffice Memorandum - For Internal Use Only

To determine sew-ability, Dr. McCarthy placed a suture through the sewing area of a closed ring sample and
pulled the suture back and forth a few times to see how well the suture slid through. Based on this review, he
felt that the sewing area was adequate, though there was no specific mention of parachuting.

In regards to the holder he did not provide any significant feedback, but indicated that he liked it.

At the conclusion of the ring discussion, he requested samples of the closed ring design (with and without
cloth), and was told that he would be sent samples in a few weeks. He was also informed that we needed to
confirm the intellectual property status of the ring with Edwards legal before he could have outside
discussions regarding the rings design.

Mitral Valve Calipers and Sizing: After the ring discussion, Dr. McCarthy was shown a prototype mitral valve
caliper that closely resembled the design used for design verification testing.

Dr. McCarthy's response was positive. He had some brief trouble establishing the correct initial hand position
and managed to get the ruler off of the track, but was able to quickly figure it out. In trying to use the device,
he was OK with the measurement method and with his ability to adequately read the measurements. He had
some initial questions on the device resistance, but after some use of the device, he seemed to feel that it
was adequate. In regards to device sterilization, he was pleased with the ability to flash sterilize the device,
so that it could more easily be used in successive procedures. .

In terms of annuloplasty ring sizing, Dr. McCarthy indicated that he might want to use the calipers to measure
the posterior leaflet. His current evaluation of the posterior leaflet length is based on qualitative visual
assessment and the calipers may allow for that assessment to be quantified (at a previous discussion Dr.
McCarthy indicated that he upsized by one for large posterior leaflets and downsized by one for small
posterior leaflets).

The engineering team indicated that they would try to make the caliper available to him by the end of the
month.

Implant Schedule: Dr. McCarthy indicated that if the first 10 implants went well, he would feel comfortable
expanding the use of the device to other surgeons and listed a number of surgeons that he felt may be good
choices for expanded use of the ring.

In regards to the ring's availability, Dr. McCarthy was told that we would try to have the ring available by the
end of February.

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EDWARDS CONFIDENTIAL. PROVIDED PURSUANT TO SENATE RULE XXIX." EW-S-20000169