Pivotal Trial to Evaluate the Safetyand Efficacy of the Diamondback360° Orbital Atherectomy System  in Treating De Novo, S...
Severe Coronary Calcium is UnderEstimated and Under Appreciated• Despite being a relatively common problem there  have bee...
Complications• Calcified Lesions     Prone to dissection during balloon angioplasty or      pre-dilatation1     Difficul...
Outcomes in Calcified Lesions                    Unstudied population                                                     ...
ORBIT II Pivotal Trial to Evaluate the Safety and Efficacy of the   Diamondback 360° Orbital Atherectomy System inTreating...
Orbital Technology for Calcified             Coronary Arteries         Easy setup and use         Control of device in o...
Unique Mechanism of Action                  Differential Orbital SandingCrown will only                                   ...
Unique Mechanism of Action• Orbiting Crown Enables  • Continuous flow of blood and saline     • Minimizes thermal injury  ...
Coronary OAS Mechanism Of Action• Video                     *Caution – Investigational Device.                     Limited...
ORBIT II Study Design• To evaluate safety and efficacy of coronary OAS to prepare  de novo severely calcified coronary les...
The ORBIT II Trial: Primary EndpointsPrimary Safety Endpoint: 30-Day MACE   •   MI defined as CK-MB level > 3 times ULN   ...
Inclusion Criteria• The target lesion must be a de novo coronary lesion  that has not been previously treated with any  in...
ORBIT II Severe Calcification Definition:Only Includes The Most Severely Calcified LesionsMintz1 1995 calcium definition  ...
Exclusion Criteria• Diagnosed with chronic renal failure unless under hemodialysis, or has  a serum creatinine level >2.5 ...
ORBIT II: Demographics & CharacteristicsDemographics                                                                   N=4...
ORBIT II: Primary Safety Endpoint30 Day MACE Rate Components:      MI (CK-MB >3x ULN):                                    ...
ORBIT II: Primary Efficacy EndpointProcedural Success Components:      Successful Stent delivered:                        ...
Non Q Wave MI in Severely Calcified Lesions        Mosseri (2005)1                                          Clavijo (2006)...
Death Rates in Severely Calcified Lesions 3                                        2.6%                                   ...
ORBIT I Trial• First-in-man study using orbital atherectomy in coronary arteries• Designed to demonstrate safety and perfo...
ORBIT II Case Studies: LCX (Baseline)Female, 70 years oldHistory of DM, smoker,dyslipidemia, HTN, EF 50%,Positive stress t...
ORBIT II Case Studies: LCX (Treatment)1.25 mm CrownWith Electric OADLow Speed, 15SecondsHigh Speed, 15Seconds             ...
ORBIT II Case Studies: LCX (Post OAS)                      Caution – Investigational Device.                      Limited ...
ORBIT II Case Studies: LCX (Final)             Single DES                          Caution – Investigational Device.      ...
Conclusion• The ORBIT II trial was unique in enrolling only patients with  severely calcified coronary arteries• The ORBIT...
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ACC: Slides from ORBIT II

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SAN FRANCISCO—Results from ORBIT II, a clinical trial designed to evaluate the safety and efficacy of the Diamondback 360° Orbital Atherectomy System to treat de novo severely calcified coronary lesions, were presented March 9 at the American College of Cardiology (ACC) scientific session.

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ACC: Slides from ORBIT II

  1. 1. Pivotal Trial to Evaluate the Safetyand Efficacy of the Diamondback360° Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II) Jeff Chambers, MD Director of Research Cardiac Catheterization Lab Director Metropolitan Heart and Vascular Institute Mercy Hospital, Minneapolis, MN Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  2. 2. Severe Coronary Calcium is UnderEstimated and Under Appreciated• Despite being a relatively common problem there have been no FDA IDE PMA trials studying only patients with severe coronary calcification• Due to poor clinical outcomes, including higher MACE and angiographic complications, patients with severe calcium have been excluded from almost all large scale clinical trials.
  3. 3. Complications• Calcified Lesions  Prone to dissection during balloon angioplasty or pre-dilatation1  Difficult to completely dilate2  Can prevent adequate stent expansion3  Preclude stent delivery to the desired location4 1 Fitzgerald PJ, et al.. Circulation. 1992:86;64-70. Kahn J, et al. Cathet Cardiovasc Diagn. 1990;21:89-91. 2 Cavusoglu E, et al. Cathet Cardivasc Intervent. 2004;62:485-498 3 Moussa I, et al. Circulation. 1997;96(1):128-136.. 4 Gilutz H, et al. Cathet Cardiovasc Intervent. 2000;50:212-214.
  4. 4. Outcomes in Calcified Lesions Unstudied population Type of Calcification Publication Severe Calcium / Total Pts ReportedDill Eur Heart J, 2000 98 / 249 CalcifiedSafian CCI, 2001 54 / 254 CalcifiedDoshi AJC, 2003 557 / 843 Moderate/severeMosseri CRM, 2005 75 / 540 SevereClavijo CCI, 2006 81 / 81 HeavyNote: Includes retrospective data and lack of core lab adjudication Weighted Average Procedural Success = 84% Weighted MACE Rate at 30 days = 15.9% 3
  5. 5. ORBIT II Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360° Orbital Atherectomy System inTreating De Novo, Severely Calcified Coronary Lesions Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  6. 6. Orbital Technology for Calcified Coronary Arteries  Easy setup and use  Control of device in operating field  .012” OAS guide wire  Compatible with 6 French guiding cathetersEccentric Crown Electric OAS Electric OAS ViperWire™ Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  7. 7. Unique Mechanism of Action Differential Orbital SandingCrown will only Soft components sand the hard (plaque/tissue)components of flex away from plaque crown Orbital Mechanism • Increased speed = Increased centrifugal force • Greater centrifugal force = Larger orbital diameter CF=Mass×Rotational speed2 Radius of the orbit Actual results may vary depending on device-to-lumen ratio, run time and speed, and plaque morphology.
  8. 8. Unique Mechanism of Action• Orbiting Crown Enables • Continuous flow of blood and saline • Minimizes thermal injury • Potentially decreases no-reflow and periprocedural cardiac enzyme elevation • One crown treats different vessel diameters based on orbiting speed Actual results may vary depending on device-to-lumen ratio, run time and speed, and plaque morphology.
  9. 9. Coronary OAS Mechanism Of Action• Video *Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  10. 10. ORBIT II Study Design• To evaluate safety and efficacy of coronary OAS to prepare de novo severely calcified coronary lesions for enabling stent placement  Prospective  Multi-center trial  Single arm - FDA recommendation as there are no FDA-approved percutaneous treatments for patients with severely calcified lesions. 443 patients enrolled in 49 US sites 30 days follow-up Complete in 97.7% (N=430/440) Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  11. 11. The ORBIT II Trial: Primary EndpointsPrimary Safety Endpoint: 30-Day MACE • MI defined as CK-MB level > 3 times ULN • Target vessel revascularization (TVR) • Cardiac deathPrimary Efficacy Endpoint: Procedural Success • Success in facilitating stent delivery with a final residual stenosis of <50% and without in-hospital MACE In Hospital MACE Impacts Both Primary Endpoints Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  12. 12. Inclusion Criteria• The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.• The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0mm.• The target lesion must not exceed 40mm.• The target vessel must have a TIMI 3 flow at baseline.• The target lesion must have fluoroscopic or IVUS evidence of severe calcium deposit at the lesion site based on the protocol definition Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  13. 13. ORBIT II Severe Calcification Definition:Only Includes The Most Severely Calcified LesionsMintz1 1995 calcium definition • Moderate: radiopacities noted only during the cardiac cycle before contrast injection • Severe: radiopacities noted without cardiac motion before contrast injection generally compromising both sides of the arterial lumenORBIT II Severe Calcium • Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location. • Total length of calcium (including segmented) must be at least 15 mm and extend partially into the target lesion • OR presence of ≥ 270° of calcium at one cross section via IVUS 1. Mintz , et al. Circulation. 1995 Apr 1;91(7):1959-65.
  14. 14. Exclusion Criteria• Diagnosed with chronic renal failure unless under hemodialysis, or has a serum creatinine level >2.5 mg/dl.• Evidence of current LVEF ≤25% (where current is defined as the latest LVEF measurement completed within the last 6 months).• Subject with angiographically confirmed evidence of more than 1 lesion requiring intervention, unless the treatment of the lesions is staged.• Target vessel has a stent from previous PCI unless 1) the stent was implanted greater than 30 days prior to the index procedure, and 2) the stent has no higher than 30% in-stent stenosis, and 3) the stent is on a different branch than the target lesion.• Target lesion is an ostial location (within 5 mm of ostium) or an unprotected left main lesion.• Target lesion is a bifurcation or has a ≥ 1.5 mm side branch.• Target lesion has thrombus or dissection. Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  15. 15. ORBIT II: Demographics & CharacteristicsDemographics N=443 Male 64.6% Age (yrs) 71.4 History of diabetes mellitus 36.2% History of CABG 14.7% History of dislipidemia 91.9% History of hypertension 91.6% Smoker (current or previous) 66.1%Vessel & Lesion Characteristics Mean pre-procedure target lesion length 18.9 mm Mean pre-procedure percent stenosis 84.4% IVUS degree of calcium (35/440, 8%) 270-360° Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  16. 16. ORBIT II: Primary Safety Endpoint30 Day MACE Rate Components: MI (CK-MB >3x ULN): 9.7% Non Q-wave 8.8% Q-wave 0.9% TVR/TLR: 1.4% TVR 0.7% TLR 0.7% Cardiac death: 0.2% Performance Goal = 83% Freedom from 30 Day MACE = 89.8% (95% CI = 87.0%, 92.7%)80% 85% 90% 95% 100% Caution – Investigational Device. Results based on Clinical Events Limited by Federal (or United States) Committee adjudication law to investigational use.
  17. 17. ORBIT II: Primary Efficacy EndpointProcedural Success Components: Successful Stent delivered: 97.7% Less than 50% residual stenosis: 98.6% In hospital MACE: 9.5% MI (CK-MB >3x ULN): 9.3% Non Q-wave 8.6% Q-wave 0.7% TVR: 0.7% Cardiac death: 0.2% Performance Goal = 82% Procedural Success = 89.1% (95% CI = 85.8%, 91.8%)80% 85% 90% 95% 100% Caution – Investigational Device. Results based on Clinical Events Limited by Federal (or United States) Committee adjudication law to investigational use.
  18. 18. Non Q Wave MI in Severely Calcified Lesions Mosseri (2005)1 Clavijo (2006)2 ORBIT II Orbit II calcium Mintz 1995 calcium definition Mintz 1995 calcium definition definition n = 662 n = 150 n = 44330% Increasing calcium deposits 30 30 increases the incidence of non 25.8%25% Q-wave MI 25 25 20.9% 19.8%20% 20 2015% 12.3% 15 15 9.8%10% 8.0% 10 10 8.6%5% 5 50% 0 0 0-90° 91-180° 181-270° 271-360° SES RA+SES OAS+DES/BMS n = 315 n = 186 n = 86 n = 75 n = 69 n = 81 n = 443 1.Mosseri, et al. Cardiovascular Caution – Investigational Device. Revascularization Medicine. 2005. 6:147-153. Limited by Federal (or United States) 2. Clavijo, et al. Catheterization and law to investigational use. Cardiovascular Interventions. 2006. 68:873–878 Data on file at CSI.
  19. 19. Death Rates in Severely Calcified Lesions 3 2.6% Clavijo 20062.5 (SES) 2 Clavijo 2006 1.7% (RA+SES) 1.5%1.5 Mosseri 1 2005(BMS)0.5 ORBIT II 0.2% (OAS+DES/BMS) 0 Mortality (%) 30 day 1. Clavijo, et al. Catheterization and Cardiovascular *Caution – Investigational Device. Interventions. 2006. 68:873–878 Limited by Federal (or United States) 2.Mosseri, et al. Cardiovascular Revascularization law to investigational use. Medicine. 2005. 6:147-153. Data on file at CSI.
  20. 20. ORBIT I Trial• First-in-man study using orbital atherectomy in coronary arteries• Designed to demonstrate safety and performance in calcified coronary lesions • Prospective, single-arm • 2 centers OUS • 50 subjects with >90⁰ of calcium via IVUS • Compared to ORBIT II • Shorter lesions • Less B2/C lesions 30 days1 6 months1 2 years2 3 years2 MACE rate 3/50 (6%) 4/50 (8%) 5/33 (15%) 6/33 (18.2%) Cardiac Death 0 (0%) 1 (2%) 2 (6%) 3 (9.1%) Q-wave MI 0 (0%) 0 (0%) 0 (0%) 0 (0%) Non Q-wave MI 3 (6%) 3 (6%) 3 (9%) 3 (9.1%) TLR 1 (2%) 1 (2%) 1 (3%) 1 (3%) 1. Parikh, K. et al. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: The ORBIT I Trial.Catheter Caution – Investigational Device. Cardiovasc Interv. 2013 Mar 5. Limited by Federal (or United States) 2. Parikh, K. et al. JACC:Cardiovascular law to investigational use. Interventions, Vol. 6, No. 2, Suppl s, 2013
  21. 21. ORBIT II Case Studies: LCX (Baseline)Female, 70 years oldHistory of DM, smoker,dyslipidemia, HTN, EF 50%,Positive stress testLesion length 24 mm Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  22. 22. ORBIT II Case Studies: LCX (Treatment)1.25 mm CrownWith Electric OADLow Speed, 15SecondsHigh Speed, 15Seconds Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  23. 23. ORBIT II Case Studies: LCX (Post OAS) Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  24. 24. ORBIT II Case Studies: LCX (Final) Single DES Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
  25. 25. Conclusion• The ORBIT II trial was unique in enrolling only patients with severely calcified coronary arteries• The ORBIT II trial met the primary safety and efficacy endpoints by a significant margin• There was a decrease in the incidence of MACE (mortality, MI and TVR) in comparison to the historical controls when this device was used• The improvement in clinical outcome might be attributed to the unique mechanism of action of OAS• OAS is a technology that may address an unmet treatment need for this difficult to treat patient population Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.

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