BEST PRACTICES RESEARCH
New Product Innovation, Aortic staplers for open AAA surgeries
sector, Europe, 2011
Frost & Sullivan’s Global Research Platform
Frost & Sullivan is in its 50th year in business with a global research organization of 1,800
analysts and consultants who monitor more than 300 industries and 250,000 companies.
The company’s research philosophy originates with the CEO’s 360 Degree Perspective™,
which serves as the foundation of its TEAM Research™ methodology. This unique approach
enables us to determine how best-in-class companies worldwide manage growth,
innovation and leadership. Based on the findings of this Best Practices research, Frost &
Sullivan is proud to present the 2011 European New Product Innovation Award in aortic
staplers for open AAA surgeries sector to ES Vascular Ltd. (Israel).
Significance of the New Product Innovation Award
Key Industry Challenges Addressed by ES Vascular Ltd.’s – Stapler f or open
aortic surgery (OAS)
American Heart Association (AHA) and American College of Cardiology (ACC) findings
estimate that aneurysm rupture is the 13 th leading cause of death in the United States
alone in men over 55, resulting in approximately 15,000 deaths every year. The aortic
aneurysm repair market is emerging with several companies striving to develop endograft
and fixation technologies that more closely approximate the manner in which surgeon
performs open surgical repair of aortic aneurysms.
Abdominal aortic aneurysm (AAA) surgical procedures are mostly open, lengthy, typically
requiring two-three hours, and are found to require quite a long in-hospital stay. Suturing
the challenging graft-aorta anastomosis accounts for long clamping times and re-clamping
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cycles that invariably pose risk for the patient. Moreover, technical hurdles involving
highly calcified aorta has been shown to hamper the development of stapling devices
developed for vascular surgery till date. Realizing the need of creating stapling devices
that allow the physician to perform an endovascular repair in a more durable and
compliant method and one which that could be
more applicable to a
wider patient
population, ES Vascular Ltd. has ventured into the development of an innovative one-shot,
instantaneous anastomotic stapling device.
ES Vascular Ltd., a firm found in 2003 by Professor Edward Shifrin, chief of vascular
surgery (Assuta Hospital, Israel) is engaged in developing innovative devices in the field of
vascular surgery, focusing on aorta and peripheral arteries. The privately-held Israeli
medical device firm has developed a unique stapling technology in and around the main
circulatory system (aorta-iliac-femoral-popliteal arteries) for patients suffering from
aneurysms or occlusions of the main arteries.
Open aortic stapler product designed by ES Vascular Ltd. is capable of simplifying the
anastomosis of synthetic grafts to the aorta during AAA repair. This single use OAS device
provides a one-shot, perfect anastomosis while connecting a synthetic graft to the aorta
for AAA repair. The quick and uniform sutureless anastomosis procedure enabled by OAS
is believed to eliminate up to 90% of suturing time involved and reduces clamping as well
as operative times while at the same time minimizing re-clamping cycles and bleeding.
OAS device allows surgeons to treat abdominal aortic aneurysms through a minimally
invasive approach while still providing the control options of an open repair procedure.
Impact of New Product Innovation Aw ard on Key Stakeholders
The New Product Innovation Award is a prestigious recognition of ES Vascular Ltd.’s
accomplishments in the aortic staplers for open AAA surgeries sector. An unbiased, thirdparty recognition can provide a profound impact in enhancing the brand value and
accelerating ES Vascular Ltd.’s growth. As captured in Chart 1 below, by researching,
ranking, and recognizing those who deliver excellence and best practices in their
respective endeavors, Frost & Sullivan hopes to inspire, influence, and impact three
specific constituencies:

Investors
Investors and shareholders always welcome unbiased and impartial third-party
recognition. Similarly, prospective investors and shareholders are drawn to
companies with a well-established reputation for excellence. Unbiased validation is
the best and most credible way to showcase an organization worthy of investment.

Customers
Third-party industry recognition has been proven to be the most effecti ve way to
assure customers that they are partnering with an organization that is leading in its
field.
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
Employees
This Award represents the creativity and dedication of ES Vascular Ltd.’s executive
team and employees. Such public recognition can boost morale and inspire your
team to continue its best-in-class pursuit of a strong competitive position for ES
Vascular Ltd.
C har t 1 : B es t P rac t i ces L ev e ra g e fo r Gr ow t h Ac ce l era t i on
Key Benchmarking Criteria f or New Product Innovation Aw ard
For the New Product Innovation Award, the following criteria were used to benchmark ES
Vascular Ltd.’s performance against key competitors:
• Innovative Element of the Product
• Leverage Leading Edge Technologies in Product
• Value Added Features/Benefits
• Increased Customer ROI (small change)
• Customer Acquisition/Penetration Potential
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Decision Support Matrix and Measurement Criteria
To support its evaluation of best practices across multiple business performance categories,
Frost & Sullivan employs a customized Decision Support Matrix (DSM). The DSM is an
analytical tool that compares companies’ performance relative to each other with an
integration of quantitative and qualitative metrics. The DSM features criteria unique to each
Award category and ranks importance by assigning weights to each criterion. The relative
weighting reflects current market conditions and illustrates the associated importance of
each criterion according to Frost & Sullivan. Fundamentally, each DSM is distinct for each
market and Award category. The DSM allows our research and consulting teams to
objectively analyze each company's performance on each criterion relative to its top
competitors and assign performance ratings on that basis. The DSM follows a 10-point scale
that allows for nuances in performance evaluation; ratings guidelines are shown in Chart 2.
C har t 2 : P erf o rm an c e - Bas e d Ra t i ng s fo r D e cis i on S u pp o r t Ma tr i x
This exercise encompasses all criteria, leading to a weighted average ranking of each
company. Researchers can then easily identify the company with the highest ranking. As a
final step, the research team confirms the veracity of the model by ensuring that small
changes to the ratings for a specific criterion do not lead to a significant change in the
overall relative rankings of the companies.
C har t 3 : Fr os t & S ul l iva n ’s 10-S t e p P r oc ess f or I de n t ify in g Awa rd R ec ip i en ts
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Best Practice Award Analysis for ES Vascular Ltd
The Decision Support Matrix, shown in Chart 4, illustrates the relative importance of each
criterion for the New Product Innovation Award and the ratings for each company under
evaluation. To remain unbiased while also protecting the interests of the other
organizations reviewed, we have chosen to refer to the other key players as Competitor 1
and Competitor 2.
C har t 4 : D ec is io n S u p po r t M at ri x f or
Ne w P r o du c t I nn o va ti o n A war d
Relative Weight (%)
Weighted Rating
Customer
Acquisition/Penetration
Potential
Increased Customer ROI
(small change)
Value Added
Features/Benefits
Leverage Leading Edge
Technologies in Product
Award Criteria
Innovative Element of the
Product
Measurement of 1–10 (1 = lowest; 10 = highest)
20% 20% 20% 20% 20% 100%
ES Vascular Ltd.
8.5
8.5
9
8.5
8.5
8.6
Competitor 1
8
7.5
7.5
8
7.5
7.7
Competitor 2
8
8
8
7.8
8
7.96
Criterion 1: Innovative Element of the Product
The open aortic stapler developed by ES Vascular Ltd. is designed to form a continuous
ringed line of staples with no gaps between adjoining staples to eliminate leakage and
bleeding completely. The open aortic stapler is simple and easy to use and enables quick
anastomosis between aorta and the artificial grafts or stent-grafts. The stapler integrates
into existing procedures and does not necessitate radical changes in common practice. In
clinical trials conducted in Europe, the OAS device has shown superiority over manual
suturing. ES Vascular’s device - OAS has completed human clinical trials and is approved for
sales in EU. The device production and sales is active in EU region and with the current
sales in progress, two distribution agreements have been signed by the company in Asia
Pacific and Italy.
Criterion 2: Leverage Leading Edge Technologies in Product
ES Vascular’s initial product – the open aortic stapler is used for open repair of abdominal
aortic aneurysms providing a one-shot, perfect anastomosis while connecting the synthetic
graft to the aorta. The clinical studies performed on 19 patients demonstrated 100%
success rates and the company is planning to introduce a novel technique for treating
common peripheral artery diseases, combining both endarterectomy and Fem-Pop bypass
procedures into a single laparoscopic procedure with superior long term results by extending
OAS technology further.
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ES Vascular is also involved in developing endovascular aortic stapler used in abdominal and
thoracic EVAR procedures. This endovascular aortic stapler can be practically used with all
types of currently existing stent-grafts and is designed to significantly lower Endoleakage
and endo-graft migration rates, thereby reducing the need for patients to undergo
additional corrective procedures following stent graft failure. The company is expected to
start clinical trial with this endovascular aortic stapler for CE mark approval at the Augusta
hospital, Dusseldorf Germany in Q2 2011. In addition to this, ES Vascular Ltd. is involved in
developing a critical limb ischemia endostapler that will facilitate a minimally invasive
procedure for replacing open femoral-popliteal bypass operations.
Criterion 3: Value Added Features/Benefits
Approximately, 90,000 open surgical AAA procedures are noted to be performed in US,
Canada, and EU regions (54,000 in EU alone), additional growing market in Asia Pacific
regions is envisioned according to a sales agreement released by ES Vascular Ltd. These
numbers are expected to grow significantly upon approval of Medicare reimbursement for
diagnostic screening of people aged 65 years and over. The single-use open aortic stapler
developed by ES Vascular Ltd. is intended to be used for both elective and emergency
treatment procedures and in cases of large vessel trauma as well. The usage of OAS is
found to significantly reduce the time of the surgical procedure. For the patients, this means
shortening of the cross clamping time and lower risk of developing complications related to
this. Due to the reduction of surgical time, there is lesser risk for complications related to
general anesthesia that includes prolonged ventilation, lowering of the body temperature,
and exposure to infections. The company believes that an eventual extension of their OAS
product through a modified laparoscopic variation of the same device will allow the firm to
gain additional access to 315,000 patients in the US and EU regions together undergoing
aorto-bifemoral bypass surgeries and balloon angioplasty procedures.
Criterion 4: Increased Customer ROI
In December 2010, ES Vascular Ltd. completed the establishment of an approved
production line for OAS device and January 2011, the firm initiated deliveries of OAS based
upon existing and additional exclusive distribution agreements in the EU market. In parallel,
the firm is engaged in process of obtaining FDA approval (510K pathway status for OAS) as
well. ES Vascular’s mission is to commercialize the devices initially via licensing agreements,
directly by distribution networks, and as additional device matures and becomes available
by liaising with a strategic partner that operates in the grafts/stent graft market. Through
OAS device, both patients and the healthcare system are believed to benefit from a
performance enhancing device that are also cost-reducing and at the same time presenting
and effective treatment option with superior long term clinical efficacy.
Criterion 5: Customer Acquisition/Penetration Potential
ES Vascular has already signed two distribution agreements for Italy and Asia Pacific
regions, wherein the Asia Pacific contract presents a 140M$ minimum purchase commitment
over 10 year period for OAS device. Medtronic and Maquet Cardiovascular divisions have
shown immense interest in ES Vascular’s devices and they are currently reviewing the
underlying technology. The OAS device was presented during VEITHE symposium and
successful clinical trial results is believed to significantly increase the company’s valuation.
The company has so far filed 9 patent applications (and their associated national filings) in
order to protect its innovative technologies and clinical breakthroughs. Initially the first US
patent was granted back in 2007, second US patent granted in November 2009 and other
patent applications are pending approval.
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Conclusion
ES Vascular Ltd.’s open aortic stapler device provides a promising platform to clinicians for
stapling synthetic grafts to the aorta during open AAA vascular interventions. Over a long
term, a growing market for ES Vascular Ltd.’s single use open aortic stapler product is
envisioned to be found in anastomosis procedures while connecting a synthetic graft to
the aorta for AAA repair, thus bestowing the company with the Frost & Sullivan New
Product Innovation Award.
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The CEO 360 Degree PerspectiveTM - Visionary Platform for Growth
Strategies
The CEO 360 Degree Perspective™ model provides a clear illustration of the complex
business universe in which CEOs and their management teams live today. It represents
the foundation of Frost & Sullivan's global research organization and provides the basis on
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analysis of best-practice performance by industry leaders.
The CEO 360 Degree Perspective™ model enables our clients to gain a comprehensive,
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C har t 5 : H ow th e C E O's 3 60 D e gr e e P ers p ec ti v e ™ M od e l Di r e cts Ou r R e se arc h
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Critical Importance of TEAM Research
Frost & Sullivan’s TEAM Research methodology represents the analytical rigor of our
research process. It offers a 360 degree view of industry challenges, trends, and issues by
integrating all seven of Frost & Sullivan's research methodologies. Our experience has
shown over the years that companies too often make important growth decisions based on
a narrow understanding of their environment, leading to errors of both omission and
commission. Frost & Sullivan contends that successful growth strategies are founded on a
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growth strategies for our clients.
C har t 6 : B e nc h mar ki ng P e rf or ma nc e w i t h TE A M R es ea rc h
About ES Vascular Ltd. (Israel)
ES Vascular Ltd., a privately-held Israeli medical device company has developed the firstever vascular stapling technology that enables revolutionizing vascular surgery to a great
extent. This firm is engaged in the development, manufacturing, licensing, and
commercialization of its proprietary product line of one-shot, instantaneous anastomotic
stapling devices. Using these devices allows the company to achieve a $5 billion market
comprising four key vascular procedures – open repair of aortic aneurysms, aorto-bifemoral/iliac
bypass,
endovascular
aortic
aneurysm
repair
with
stent
grafts
and
replacement of current above-knee superficial femoral artery peripheral interventions.
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