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 (Multicentric in 10 Brazilian Institutions)
Inspiron Real Life Study I – Novel DES in high-risk patients³
Study Design
Baseline characteristics (n-470)
Main Clinical Results
1 – Angiographically Non-inferiority vs. biolimus eluting stent at 9 months.¹
DESTINY Trial ¹ ²
Study Design (Multicentric in 10 Brazilian Institutions)
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 Healing 6
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. |
| INSTEMI Registry | 1417 | Physician-initiated retrospective study in patients with ST-elevation myocardial infarction |
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.
