Interventional Cardiology

Inspiron

Main Characteristics Clinical Trials Ordering Information

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.

Catalogue

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.

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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Multicenter, prospective, randomized study to evaluate by OCT the healing score after stent implantation at 1, 2 and 3 months (NCT03269461).
  7. 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.