The Stealth 360™ Peripheral Orbital Atherectomy System (OAS) has been well-studied in over 4,800 patients and in more than 7,000 lesions with durable results.1 In the LIBERTY 360 trial, primary patency was 89.7% at 2 years in RC 2-3 patients2 and the 3-year freedom from major amputation was 88.6% in RC 6 patients.3
LIBERTY is the largest, contemporary, real-world study to evaluate procedural and long-term clinical outcomes of endovascular device interventions in patients with symptomatic lower extremity Peripheral Artery Disease (PAD).4
Peripheral Vascular Intervention (PVI) may be a reasonable treatment option across all Rutherford classes with durable results lasting to 3 years.4
A prospective, randomised, multi-centre study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + Percutaneous Transluminal Angioplasty (PTA) versus PTA alone in calcified below-the-knee (BTK) lesions.7
Demographics | OAS + PTA (n=25) | PTA Alone (n=25) | p-value |
---|---|---|---|
Mean Age | 70.7 ± 13.4 | 71.8 ± 10.9 | 0.75 |
Male/Female | 68%/32% | 60%/40% | 0.77 |
Diabetic Type 1 | 4% | 0% | 1.00 |
Diabetic Type 2 | 68% | 56% | 0.56 |
Renal Insufficiency (GFR <90) | 25% | 24% | 1.00 |
Smoker (current or previous) | 60% | 60% | 1.00 |
CAD | 44% | 56% | 0.57 |
Hypertension | 84% | 84% | 1.00 |
Dyslipidaemia | 83% | 72% | 0.50 |
Mean Maximum Balloon Inflation Pressure (atm)
p=0.001
Rate of Bail-Out Stenting
p=0.44
Freedom From Revascularisation at 12 Months
p=0.14
Freedom From Major Adverse Events at 12 Months
p=0.006
A prospective, single-arm, single-centre study using Intravascular Ultrasound (IVUS) to assess Orbital Atherectomy System (OAS)-related plaque modification of femoropopliteal lesions.8
Baseline Characteristics | (n=25) |
---|---|
Age | 70.4 ± 7.8 years |
Gender (Male) | 19/25 (76.0%) |
eGFR (mL/min/1.73 m2) | 70.9 ± 25.0 |
History of diabetes (Type I or II) | 18/25 (72.0%) |
History of hyperlipidaemia | 25/25 (100.0%) |
History of hypertension | 25/25 (100.0%) |
Smoker (current or former) | 21/25 (84.0%) |
Rutherford classification | 3.0 ± 0.0 |
Rutherford Classification (RC) | Baseline (n=25) | 12-Month Follow-up (n=22) |
---|---|---|
Asymptomatic (RC 0) | 0 (0.0%) | 13 (59.1%) |
Mild Claudication (RC 1) | 0 (0.0%) | 8 (36.4%) |
Moderate Claudication (RC 2) | 0 (0.0%) | 1 (4.5%) |
Severe Claudication (RC 3) | 25 (100.0%) | 0 (0.0%) |
ABI* | 0.74 ± 0.13 (n=22) | 0.95 ± 0.15 (n=21) |
*Greater of posterior tibial or dorsalis pedis systolic pressure divided by maximum of left or right brachial systolic pressure.
p-value <0.001 for Rutherford Classifications and ABI
At 12 months, the freedom from target lesion revascularisation rate was 91.8%, and ankle-brachial index and Rutherford classification improved significantly from baseline through follow-up.
A prospective, randomised, multi-centre study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + Percutaneous Transluminal Angioplasty (PTA) versus PTA alone in calcified above-the-knee (ATK) lesions.9
Comorbidity | OAS + PTA (n=25) | PTA Alone (n=25) | p-value |
---|---|---|---|
Mean Age ± SD | 68.0 ± 11.0 | 71.3 ± 10.5 | 0.27 |
Female gender, n (%) | 18 (72) | 16 (64) | 0.76 |
Non-Caucasian, n (%) | 9 (36) | 4 (16) | 0.19 |
Coronary artery disease, n (%) | 12 (48) | 16 (64) | 0.39 |
Diabetes, n (%) | 18 (72) | 10 (40) | 0.05 |
Hypertension, n (%) | 22 (88) | 18 (72) | 0.29 |
Hyperlipidaemia, n (%) | 23 (92) | 21 (84) | 0.67 |
Smoker (current or former), n (%) | 22 (88) | 22 (88) | >0.99 |
Mean Maximum Balloon Inflation Pressure (atm)
p<0.001
Adjunctive Stenting
p<0.001
Patency at 12 Months
p<0.99
References
MAT 2503822 V1.0
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MAT-2105201 v1.0
Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions
MAT-2105201 v1.0