STENT
POSITIONING
ASSISTANT
SYSTEM

SPAS is the first safe stent positioning device that impacts the result of the stenting through quicker and more accurate stent positioning in the affected artery part.

STENT POSITIONING
PRECISION IS THE No.1
CORONARY STENTING
CHALLENGE

The procedure of stent placement into the aortocoronary segment during angiography poses a high risk of error. Inaccurate positioning can cause complications or lead to redo surgery. Precision stent placement is thus a key task for the operating surgeon.

SPAS ENSURES
ACCURATE STENT
PLACEMENT

The new device provides accuracy within less than a millimeter. SPAS facilitates stent movement in the affected segment of the artery, while giving the surgeon more confidence at the most critical time of the operation. This results in a higher surgery success rate, fewer repeated interventions and a lower risk of complications.

ABOUT SPAS

DESCRIPTION

SPAS is an non-invasive device for mechanical positioning of a coronary stent. The device complements the stent delivery system - to become an extension of the surgeon's hand and to enhance his confidence and the accuracy of his actions at the critical and most complicated moment of surgery.

SPAS OPERATING PRINCIPLE

Its key operating principle is rotation. When a stent fixed on its delivery system reaches the artery lesion site, the surgeon begins to position it: by turning a dial or knob (several device modifications have been patented by now), the device is moved under X-ray guidance. One turn of its rotating part moves the fixed delivery system by several millimeters, which increases stent positioning precision to 0.5 mm. Bidirectional design makes it possible to move the delivery system either way.

SPAS DESIGN

SPAS is manufactured by casting from medical polymers. The device is installed on the coronary stent delivery system. It is single-use and compatible with all major manufacturers’ delivery systems. The device’s ergonomic design and compact size make it handy to hold and permits simpler and more accurate management of the stent delivery system.

ABOUT SPAS | Advantages

1

STENT POSITIONING IN LESS TIME
AND SAVING THE LIVES OF PATIENTS
WHO UNDERGO COMPLICATED
CORONARY INTERVENTIONS

One of the new design’s key advantages is shorter stent positioning time expected when the SPAS stent positioning device is used. Every second stenting becomes complicated due to artery lesion location and type, the patient’s acute condition, and/or other factors. SPAS is indispensable when ACCURACY (ostial or bifurcation lesions, trunk lesions, two or more consecutive stents to be installed) and QUICKNESS (acute myocardial infarction) are required.

2

LESS RADIATION
FOR DOCTORS
AND PATIENTS

The SPAS device and its expected shorter stent positioning time mean a lower radiation load on the medical staff — the highest risk group for such interventions in routine practice – and on the patients, and lower contrast media consumption.

3

INNOVATION
IN CORONARY STENTING

We currently see that completely biodegradable / bioresorptive scaffolds dissolving in arteries within two or more years post-installation are being more and more extensively used. One of the surgical issues when they are placed is poor imaging quality that makes positioning and implantation process for these stents even more challenging. This problem can be resolved by adopting SPAS devices in routine clinical practice.

4

REDUCED CORONARY
STENTING COSTS

Virtually all the SPAS advantages currently apparent, namely shorter surgery time, less contrast media consumption, and fewer repeated interventions expected, result in lower coronary surgery costs. And that is something in which patients, hospital management and medical insurance companies are directly.

1

SPAS — STENT POSITIONING IN LESS TIME AND SAVING THE LIVES OF PATIENTS WHO UNDERGO COMPLICATED CORONARY INTERVENTIONS

One of the new design’s key advantages is shorter stent positioning time expected when the SPAS stent positioning device is used. Every second stenting becomes complicated due to artery lesion location and type, the patient’s acute condition, and/or other factors. SPAS is indispensable when ACCURACY (ostial or bifurcation lesions, trunk lesions, two or more consecutive stents to be installed) and QUICKNESS (acute myocardial infarction) are required.

2

SPAS — LESS RADIATION FOR DOCTORS AND PATIENTS

The SPAS device and its expected shorter stent positioning time mean a lower radiation load on the medical staff — the highest risk group for such interventions in routine practice – and on the patients, and lower contrast media consumption.

3

SPAS — INNOVATION IN CORONARY STENTING

We currently see that completely biodegradable / bioresorptive scaffolds dissolving in arteries within two or more years post-installation are being more and more extensively used. One of the surgical issues when they are placed is poor imaging quality that makes positioning and implantation process for these stents even more challenging. This problem can be resolved by adopting SPAS devices in routine clinical practice.

4

SPAS — REDUCED CORONARY STENTING COSTS

Virtually all the SPAS advantages currently apparent, namely shorter surgery time, less contrast media consumption, and fewer repeated interventions expected, result in lower coronary surgery costs. And that is something in which patients, hospital management and medical insurance companies are directly.

ABOUT SPAS | Clinical cases

Coronary artery bifurcation lesions

Stent-in-stent placement to reduce overlapping area

Coronary lesions at any segment to reduce surgery time

Ostial lesions including aortocoronary ones

Acute myocardial infarction (AMI)

Stenting of visceral, brachiocephalic, cerebral arteries, upper and lower extremity arteries

RESEARCH | Study relevance

Intention to use the innovative
SPAS stent positioning device*:

*According to the findings of research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017
*According to the findings of research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017

RESEARCH INTO THE CONCEPTUAL RELEVANCE OF THE SPAS CORONARY STENT POSITIONING DEVICE:

Done by QuintilesIMS in 2017.
Interviewed were 512 interventional cardiologists and radiologists with three or more years’ work experience (13.8 years’ on average), who have performed at least 100 PCIs (percutaneous coronary interventions) involving coronary vessels stenting in the last 12 months.

Geography: the United Kingdom, Germany, India, Spain, Italy, China, USA, France, Japan.

Problems Arising from Stenting in Appropriate Clinical Situations, According to Practicing Interventional Cardiologists*:

*According to the results of the research regarding the concept relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017
% of respondents
Base: all respondents, n=512
CORONARY ARTERY BIFURCATION LESIONS
Stent positioning
72
The choice of stenting tactics
49
Side branch debulking
39
Incomplete sten
34
Bad visualization
19


OSTIAL LESIONS
Stent positioning
76
The choice of stenting tactics
42
Incomplet
31
Bad visualization
23
% of respondents
Base: all respondents, n=512
*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017

Problems Arising from Stenting in Appropriate Clinical Situations, According to Practicing Interventional Cardiologists*:

*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017
% of respondents
Base: all respondents, n=512
"STENT-INTO-STENT" IMPLANTATION
Stent positioning inaccuracy in the ovelap area
66
Obstruction of passage of one stent into the other
43
Incomplete stent deployment
38
Bad visualization
30
Protracted positioning of the subsequent stent
24
% of respondents
Base: all respondents, n=512
*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017

Problems Arising from Stenting in Appropriate Clinical Situations, According to Practicing Interventional Cardiologists*:

*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017
Left main coronary artery
Stent positioning
61
The choice of stenting tactics
50
Side branch debulking
32
Incomplete stent deployment
28
Bad visualization
15


ASC
Stent positioning accuracy
52
The choice of stenting tactics
41
Stent positioning speed
41
Incomplete stent deployment
30
Side branch debulking
26
Bad visualization
17
% of respondents
Base: all respondents, n=512
% of respondents
Base: all respondents, n=512
*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017

Complications Caused by Inaccurate Stent Positioning*:

*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017
% of respondents
Base: all respondents, n=512
Complications
Restenosis
53
Need to install an additional stent
47
Malposition
45
Side branch closure
45
Stent thrombosis
33
Dissection
32
Slow/no-reflow
26
Device jamming
19
Vessel perforation /rupture
14
No complications
1
% of respondents
Base: all respondents, n=512
*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017

The specialists interviewed are willing to use the innovative SPAS positioning device in the following clinical cases*:

*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017
% of respondents
Base: all respondents, n=512
Stenting concerning bifurcation lesions
of the coronary artery
72
Stenting ostial lesions
70
Stenting of the left main coronary artery
48
Stenting in ACS
44
"Stent-into-stent" (edge ot edge) implantation
43
Stenting of visceral, brachiocephalic, cerebreal arteries,
and arteries of the upper and lower extremities
19
% of respondents
Base: all respondents, n=512
*According to the findings of the research into the conceptual relevance of the SPAS coronary stent positioning device, QuintilesIMS, 2017

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