Interventional Cardiology

Inspiron

INSPIRON® is a 3rd generation Drug Eluting Stent designed to create a fast and homogeneous endothelialization. Its platform is the CRONUS NE® Stent, a stent which design, material (CoCr), thin struts (75 μm) and delivery system gives it good navigability, flexibility, good crossover profile, moderate radiopacity and high balloon rupture pressure. Its abluminal coating is composed of a mixture of PLA and PLGA polymers and a low Sirolimus dosage resulting in a moderate drug elution profile (60% in 10 days and 100% in 45 days), complete coating degradation between 6 and 9 months and in a fast and homogeneous endothelialization.

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Main Characteristics

Advanced design with thin struts

Cobalt chromium alloy.
75μm strut thickness.
Excellent radial force.

Rounded structure to avoid artery injury.

“S” connectors for high flexibility and navigability.

Abluminal Coating

Coating thickness – 5μm

100% Biodegradable Polymer

Complete degradation of polymers in CO‎₂ and H₂O within 9 months

Sirolimus: Low dosage and moderate elution profile

Clinical Trials

Preclinical and Clinical Trial have proven the efficacy and safety of the INSPIRON® Drug-Eluting Stent.

The Destiny Trial, a multicenter randomized study comparing INSPIRON® to a Biolimus-eluting stent, in which 170 patients -194 lesions; demonstrated noninferiority for in stent late lumen loss with p < 0.001 (primary endpoint) and the safety of the stent with no death, no thrombosis and low major adverse cardiac and cerebral events (3.6% vs. 5.45% of Biolimus-eluting stent, p= 0.7) at 9 months. The analysis of 8944 struts by OCT (Optical Coherence Tomography) showed a higher coverage rate at 9 months (99.49% vs. 97.62% for the Biolimus-eluting stent with p value<0.001).

The high rate of struts coverage was also confirmed by the REPAIR study with 97% of the struts covered at 3 months.

At 300 days, the Real Life Study I (470 patients treated / 799 stents implanted) showed that even among a very complex population (51.3% of diabetics, 68.5% of multiarterials, 58.5% had previously PCI or bypass surgery, 38.9% with bifurcation, 61.9% with type C lesion) INSPIRON®️ demonstrated an excellent efficacy and safety profile with 1.7% cardiac mortality, 5.7% target vessel revascularization and zero possible or definite thrombosis.

DESTINY Trial ¹ ²
Study Design

Inspiron Real Life Study I – Novel DES in high-risk patients³

Study Design

Baseline characteristics

Main Clinical Results

1 – Angiographically Non-inferiority vs. biolimus eluting stent at 9 months.¹

2 – OCT substudies demonstrate that INSPIRON has excellent strut coverage even at 3 months and higher strut coverage compared to Biolimus Eluting Stent with p<0.001 at 9 months.

%Covered Struts – OCT ²

Assessment of Stent Healing⁶

3 – Proven Safety and Efficacy with low rates of thrombosis in the long-term.

Inspiron Real Life I – Novel DES in high-risk patients³ – 900 days of median follow-up (n=470)*

DESTINY Trial
Clinical adverse events (up to 270 days)

First In Human (4 years)

References

Metallic Limus-eluting stents abluminally coated with biodegradable polymers: angiographic and clinical comparison of a novel ultra-thin Sirolimus Stent versus Biolimus stent in the DESTINY Randomized Trial. Cardiovascular Therapeutics, 2015; 33(6): 367-371.
Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial. Int J Cardiovasc Imaging. 2017 Feb;33(2):161-168.
Clinical performance of a novel ultrathin strut, low-dose, sirolimus-eluting stent with abluminal-only biodegradable polymeric coating for patients undergoing percutaneous coronary intervention in the daily practice. Cardiovasc Diagn Ther. 2015 Dec;5(6):414-9.
Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial. Cardiovasc Diagn Ther 2015;5(4):264-270.
First-in-man randomized comparison of a novel sirolimus-elutig stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial. EuroIntervention. 2014;9: 1380-4.
Multicenter, prospective, randomized study to evaluate by OCT the healing score after stent implantation at 1, 2 and 3 months (NCT03269461).
Prospective, non-randomized, unicentric, to assess clinical outcomes of the Inspiron Sirolimus Eluting Stent.

Study	#Patients	Study Design
Inspiron I Study	60	Multicenter, prospective, randomized study to evaluate safety and efficacy of Inspiron Sirolimus Eluting Stent (NCT01093391)
Destiny Trial	170	Multicenter, prospective, randomized study to show non-inferiority against Biolimus Eluting Stent (NCT01856088)
Inspiron Real Life Registry	470	Prospective, non-randomized study of complex population
Inspiron Real Life II Registry	5000	Multicenter, prospective, non-randomized real-world Registry (NCT03263260)
Inspiron Repair	60	Multicenter, prospective, randomized study to evaluate by OCT the healing score after stent implantation at 1, 2 and 3 months (NCT03269461)
Inspiron Latitude	500	Multicenter, prospective, non-randomized real-world study (NCT03471234)
Inspiron All-commers	790	Prospective, non-randomized, unicentric, to assess clinical outcomes of the Inspiron Sirolimus Eluting Stent.

Ordering Information

Length

Diameter	9mm*	13mm	16mm	19mm	23mm	29mm	33mm	38mm	48mm	58mm
2.25mm	–	105181	105184	105186	105187	105188	–	–	–	–
2.50mm	105024*	105025	102633	102632	105028	105029	105030	104262	–	–
2.75mm	105189*	105190	105191	105192	105193	105194	105195	105196	–	–
3.00mm	105031*	105032	102634	101335	105034	105037	105038	105041	113628	113632
3.50mm	105042*	105044	102635	102636	105047	105048	105051	105052	113629	113633
4.00mm	105197*	105198	105199	110964	110965	110966	–	–	–	–

* Unavailable for CE Market.