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Stealth 360™

Peripheral Orbital Atherectomy System

Stealth 360 Peripheral Orbital Atherectomy Device
Clinical Evidence

Clinical Evidence for Stealth 360™ Peripheral Orbital Atherectomy System

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
 

Stealth 360™ Peripheral OAS Clinical Studies

LIBERTY 360º

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

Study Design4

  • Prospective, observational, multicenter study that includes any FDA-cleared or approved technology to treat claudication and Critical Limb Ischemia (CLI).
  • 1,204 patients enrolled at 51 sites and were followed for up to five years. Four core labs were used for independent analysis.
  • Key endpoints: Procedural and lesion success, Major Adverse Events (MAEs), Duplex Ultrasound (DUS), Quality of Life (QoL), and Six-Minute Walk Test (6MWT).
  • Key inclusion criteria: Rutherford classification (RC) 2 to 6, target lesion located within or extending into 10 cm above the medial epicondyle to the digital arteries (distal 1/3 of the SFA and below), and at least one lesion that can be treated with an endovascular device.5
Liberty 360 Study Design

Conclusion

Peripheral Vascular Intervention (PVI) may be a reasonable treatment option across all Rutherford classes with durable results lasting to 3 years.4

  • High freedom from major amputation at 3 years across all Rutherford classes.4
  • In the OAS sub-analysis, freedom from major amputation rates at 3 years were even higher than in the full patient cohort.4
  • Improved Quality of Life by 30 days and maintained to 3 years across all Rutherford classes.4
  • High long-term patency rates through 2 years in RC 2-3.6
  • Improvement in mean number of wounds from 30 days to 2 years in RC 4-6.6

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CALCIUM 360º

A prospective, randomized, multi-center 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

 

Key Takeaways7

  • Lower mean maximum balloon inflation pressure in OAS+PTA arm
  • Lower rate of major adverse events at 12-months in OAS+PTA arm

 

Study Design7

  • 50 Critical Limb Ischemia (CLI) patients enrolled at 8 U.S. sites.
  • Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months.

 

Patient Population7

DemographicsOAS + PTA
(n=25)		PTA Alone
(n=25)		p-value
Mean Age70.7 ± 13.471.8 ± 10.90.75
Male/Female68%/32%60%/40%0.77
Diabetic Type 14%0%1.00
Diabetic Type 268%56%0.56
Renal Insufficiency (GFR <90)25%24%1.00
Smoker (current or previous)60%60%1.00
CAD44%56%0.57
Hypertension84%84%1.00
Dyslipidemia83%72%0.50

Study Results7

Mean Maximum Balloon Inflation Pressure (atm)

p=0.001

Diamondback 360 Calcium 360 Study Balloon Inflation

Rate of Bail-Out Stenting

p=0.44

Diamondback 360 Calcium 360 Study Bail Out Stenting

Freedom From Revascularization at 12 Months

p=0.14

Diamondback 360 Calcium 360 Study Revascularization Freedom

Freedom From Major Adverse Events at 12 Months

p=0.006

Diamondback 360 Calcium 360 Study Major Adverse Event Freedom

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TRUTH

A prospective, single-arm, single-center study using Intravascular Ultrasound (IVUS) to assess Orbital Atherectomy System (OAS)-related plaque modification of femoropopliteal lesions.8

 

Key Takeaways8

  • OAS modified the calcified component of the plaque burden (IVUS analysis).
  • Calcium reduction was responsible for 86% of lumen area increase (IVUS analysis).
  • Increase in minimum lumen area post-OAS (IVUS analysis).
  • Low mean maximum balloon inflation pressure post-OAS of 5.2 atm.

 

Study Design8

  • 25 patients enrolled at a single center.
  • Patients treated with OAS+Percutaneous Transluminal Angioplasty (PTA) and followed for 12 months.
  • IVUS images collected pre-OAS, post-OAS, and post-PTA (IVUS Core Lab).


Patient Population8

Baseline Characteristics(n=25)
Age70.4 ± 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 hyperlipidemia25/25 (100.0%)
History of hypertension25/25 (100.0%)
Smoker (current or former)21/25 (84.0%)
Rutherford classification3.0 ± 0.0


Study Results8

  • The mean maximum balloon inflation pressure was 5.2±1.2 atm.
  • Virtual histology IVUS analysis revealed at the maximum calcium ablation site that calcium reduction was responsible for 86% of the lumen area increase.
  • The minimum lumen area increased from 4.0 mm2 to 9.1 mm2 (P<0.0001).
     
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 revascularization rate was 91.8%, and ankle-brachial index and Rutherford classification improved significantly from baseline through follow-up.

 

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COMPLIANCE 360°

A prospective, randomized, multi-center 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

 

Key Takeaways9

  • Lower mean maximum balloon inflation pressure in OAS+PTA arm.
  • Lower adjunctive stent rate in OAS+PTA arm.
  • OAS demonstrated reduced stenting with durable results out to 12 months versus PTA alone.

 

Study Design9

  • 50 patients enrolled at 9 U.S. sites.
  • Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months.

 

Patient Population9

ComorbidityOAS + PTA
(n=25)		PTA Alone
(n=25)		p-value
Mean Age ± SD68.0 ± 11.071.3 ± 10.50.27
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
Hyperlipidemia, n (%)23 (92)21 (84)0.67
Smoker (current or former), n (%)22 (88)22 (88)>0.99

 

Study Results9

Mean Maximum Balloon Inflation Pressure (atm)

p<0.001

Diamondback 360 Compliance 360 Study Maximum Balloon Inflation

Adjunctive Stenting

p<0.001

Diamondback 360 Compliance 360 Study Adjunctive Stenting

Patency at 12 Months

p<0.99

Diamondback 360 Compliance 360 Study Patency at 12 Months

References

  1. Data on file at Abbott. Counts updated 06Jan2020 - subject to change (includes PAD I, PAD II, OASIS, CONFIRM, CALCIUM, COMPLIANCE, TRUTH, CLARITY, LIBERTY, OPTIMIZE, REACH PVI).
  2. Adams GL, et al. J Vasc Surg. 2019;70(5 Suppl):E188-E189.
  3. Giannopoulos S, et al. J Endovasc Ther. 2020;27(5):714-725.
  4. Mustapha JA. LIBERTY 360 Trial 3-Year Update. Presented at AMP 2019.
  5. Adams GL, et al. Am Heart J. 2016;174:14-21.
  6. Mustapha JA. Late Breaking: LIBERTY 360 2-Year Update. Presented at AMP 2018.
  7. Shammas NW, et al. J Endovasc Ther. 2012;19(4):480-488.
  8. Babaev A, et al. Vasc Endovasc Surg. 2015;49(7):188-194.
  9. Dattilo R, et al. J Invasive Cardiol. 2014;26(8):355-360.

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