STENT
POSITIONING
ASSISTANCE
SYSTEM

SPAS® introduces a new standard of care in Coronary Stenting bringing it to the next level of safety and efficiency.

NEXT LEVEL OF SAFETY
IN CORONARY STENTING

Current stenting devices are user-dependent and require strong skills in complex pathologies, such as bifurcation lesions of the coronary artery, ostial and bifurcational lesions, stenting in ongoing myocardial infraction, and edge-to-edge positioning. SPAS® allows for significantly reduced time-to-placement in any stenting procedure including complicated coronary conditions and acute myocardial infarction where time-to-stenting is crucial. SPAS® is expected to allow for higher surgery success rates, shorter hospitalization and overall decreased care costs.

HIGHEST LEVEL
OF PROFESSIONAL
CONFIDENCE

SPAS® is user independent. It eliminates possible surgeon’s hand tremor, allows for stronger confidence for less experienced interventional cardiologists. It is expected to minimize risks of misplacements, deployment of additional stents and other complications occurring due to imprecise placement. SPAS® allows for better experience for both patients and cardiologists. It reduces risks of misplacement and perforation, requires less fluoroscopy and minimizes radiation exposure.

ABOUT SPAS®

DESCRIPTION

SPAS® is a mechanical torque-like device which allows for precise stent placement by easy one-handed manipulation, with an option of back and forward movement for repositioning. SPAS® seamlessly complements any stent delivery system, becoming an “extension” of the surgeon's hand making it precisely accurate.

SPAS® OPERATING PRINCIPLE

SPAS® represents the ultimate solution for safe and precise stent positioning. This unique accessory allows for a stent placement precision at a fraction of a 0.5mm. When a stent is fixed within its delivery system, SPAS® is inserted onto delivery system of the stent. After that stent on delivery system and SPAS® device preinstalled on stent delivery system sheath put in guidewire to the lesion site under standard X-Ray guidance. The precise positioning of the stent to the target lesion site achieves by simple one-handed mechanical rotation. One turn of the rotating handle moves the delivery system by several millimetres or by a fraction of millimetre depending on the case and need.

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.

SPAS® Clinical cases

Coronary artery bifurcation lesions

Edge-to-edge 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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