Laser Atherectomy

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WELCOME
Hilton Harrisburg, September 2007
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Laser Atherectomy

• Sean Janzer MD

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devices

• Balloons
• Stents
• Cutting Balloons
• Laser Atherectomy
• Directional Atherectomy
• Cryoplasty
• Angiojet thrombectomy
• Filter Wires
• Occlusive Protection
• Re-entry catheters
• Lumend device

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Peripheral Intervenional Procedure

• Patient
• Lesion
• Equipment
• Physician
• STAFF

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Recent Laser modification

• Increasing the energy.
• Continuous ON
• Hydrophilic coating

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2.5 Extreme Vs. 2.5 Turbo

• Continuous on
• Fiber density 128 vs 99
• 23 more active area
• 30 more energy
• 59 increased pentration area
• Working length 110cm

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The Wavelength Story

• Ultraviolet vs. Infrared

193nm
2090nm
308nm
10600nm
Infrared
Ultraviolet
CO2
Excimer (CVX-300)
HoYAG
Excimer (ophthalmology)
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Spectrophotometric Scan of Fresh Thrombus
Lee et al . Am J Card. 1983 52 876-877
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Lasers inhibit platelet aggregation
Topaz, et al. Thromb Haemost. 2001681087-1093.
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Laser Options - Sites and Clinical Settings

• SFA/CFA/POP
• BTK
• CLI
• Acute Thrombotic events

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Lesion Specific

• Atheroma
• Thrombus
• Restenosis - including stents
• Calcification

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Limb Salvage Following Laser-Assisted Angioplasty
for Critical Limb Ischemia

• Results of the LACI Multicenter Trial
• John R. Laird, MD Thomas Zeller, MD Bruce H.
  Gray, DO Dierk Scheinert, MD Mitar Vranic, DO
  Christopher Reiser, PhD and Giancarlo Biamino,
  MD for the LACI Investigators

7030-0618
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Study Objective

• To evaluate the effectiveness of laser-assisted
  angioplasty for patients with CLI who were poor
  candidates for surgical revascularization

Multicenter prospective registry 14 sites (11 US
and 3 Germany) 145 patients / 155 critical
ischemic limbs
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Patient Enrollment

• Enrollment Period (April 01 April 02)
• Patients with CLI (Rutherford Category 4-6)
• Presence of ischemic rest pain
• Non-healing ulcers
• Gangrene affecting lower extremity
• Poor surgical candidates
• Absence of a suitable autologous vein
• Lack of undiseased distal vessels gt1 mm in
  diameter
• High risk of surgical mortality

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Definitions and Endpoints

• Procedural Success
• Was defined as lt50 residual stenosis in all
  lesions in the treated limb
• Primary Endpoint
• Limb salvage (avoidance of a minor amputation
  above the level of the ankle) among surviving
  patients at 6 months
• Minor Amputation
• Amputation leaving an ambulatory foot i.e., below
  the ankle
• Secondary Endpoints
• Serious adverse events including any-cause death,
  major amputation, need for surgical intervention,
  MI, stroke, acute limb ischemia, access site
  bleeding or any other event prolonging
  hospitalization

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Patient Characteristics and Baseline Limb Status
Patients N145 Men 53 (N77) Mean age, years 72
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Angioplasty Technique

• Technical Objective
• To achieve straightline flow from the SFA origin
  to the foot through at least 1 tibial artery
• Treatment
• Standard guidewire to cross lesions in SFA,
  popliteal and tibials
• Excimer laser step-by-step procedure used with
  lesions resistant to guidewire
• Adjunctive PTA and optional stenting
• Included Catheters
• 0.9 2.5 mm Spectranetics peripheral laser
  catheters

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Step-by-Step Technique
The guidewire advances a few mm into the
occlusion. The laser is activated while advancing
the laser catheter, ablating the lesion until its
tip is flush with the guidewire. The process is
then repeated until the occlusion is crossed.
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The LACI Studies

• The LACI Trial 6 Month Results
• Laird et al
• 145 pt, 155 critical ischemic limbs
• 423 lesions
• 41SFA, 15 Popliteal, 41 Infrapop
• 70 of Pts had combo occlusion and stenosis
• 29 Rutherford Class 4
• 71 Rutherford Class 5 or 6

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Procedure Results

• Guidewire crossing success 92
• Laser treatment delivered 99
• Adjunctive balloon 96
• Stent placement 45
• Procedure success 85
• lt50 residual stenosis at final
• Straightline flow to foot established 89
• Hospital stay (days) mean 3.0

Endovascular Today, October 2003 The LACI Trial
6-Month Results, p.2 Alicia
Fagan
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Procedure Results
93

• On average, 2.7 1.4 lesions were treated in
  each limb, with a median lesion length of 4.0 cm
  (range 0.250.0)
• The median total length of treated artery per
  limb was 11.0 cm (mean 16.2, range 0.2-123)
• At 6-month follow-up limb salvage was achieved
  in 110 (92) of 119 surviving patients or 118
  (93) 127 limbs

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Study Conclusion

•   Excimer laser-assisted atherectomy for CLI
  offers high technical success and limb salvage
  rates in patients identified as poor candidates
  for traditional surgical revascularization
•   Limb salvage rate of 93 in surviving patients
  is among the highest reported for endovascular
  therapy in complex infrainguinal and
  infrapopliteal disease
•   The excimer laser technology used during the
  LACI study facilitated procedure success and limb
  salvage with a minimum of in-hospital SAEs

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Turbo Booster
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Turbo Booster
Laser Catheter
Laser Catheter
Guidewire
Bias Sheath
Orientation band
Distal Marker
Orientation Band
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Turbo Booster
Top view
Rotated -90?
Orientation band
Rotated -180?
Rotated -270?
The view is such that you are looking directly
down on the device with the catheter above the
Turbo Booster
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Spectranetics Current Studies

• CELLO-CLiRpath Excimer Laser to Enlarge Lumen
  Openings
• Objective Assess the safety and efficacy of the
  Turbo Booster.
• Primary Efficacy Endpoint 20 reduction on
  average in DS post turbo booster compared to
  pre-procedure.
• Secondary Endpoints To Achieve lt 30 residual
  stenosis post all adjunctive therapy, volumetric
  IVUS analyses.
• Study Design 15 sites, 85 patients, de novo,
  restenotic SFA and popliteal lesions/occlusions,
  2cm-15cm treatment segment (single or multiple
  lesions), Rutherford 1-3
• Follow-up Duplex doppler at 1,6, 12 months.
• Duration 18-24 months

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General Study Information

• CELLO - CLiRpath Excimer Laser System to Enlarge
  Lumen Openings
• Prospective, multi-center, non-randomized study
  taking place at up to 15 centers in the United
  States (later expanded to 20 sites)
• Objective - evaluate the safety and efficacy of
  the TURBO Booster, in combination with the
  available laser catheters 2.0 mm, to create
  larger lumens for treatment within the
  superficial femoral and popliteal arteries.

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General Study Information

• Primary Endpoints
• Efficacy
• Laser success - defined as achieving ?20 average
  reduction in the percent () diameter stenosis,
  post-laser and prior to adjunctive therapy, based
  on angiographic core laboratory analysis.
• Safety
• Occurrence of major adverse events (clinical
  perforation, major dissection requiring surgery,
  major amputation, cerebrovascular accidents
  (CVA), myocardial infarction, and death at the
  time of the procedure), prior to release from the
  hospital, at 30 days, and at six (6) months
  post-procedure.

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General Study Information

• Secondary Endpoints
• Acute procedural success
• Achievement of ?30 final residual stenosis, (by
  angiography after all adjunctive treatments)
• Lumen diameters and volumetric plaque reduction
  immediately after treatment with the Laser as
  determined by IVUS

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Results

• 65 patients enrolled
• 61 patients supported the 510(k) premarket
  notification for clearance of the Turbo-Booster
  post 30-day follow-up.
• 16 training cases
• 45 analysis cohort cases
• Demographics
• Average age was 69 years (42-87)
• 36 (59) males and 25 (41) females
• Average height and weight was 67 inches and 182
  pounds

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General Study Information

• Anatomic Exclusion Criteria
• Identification of any lesion above the knee
  and/or below the knee in the treated leg
  (ipsilateral) that will require preplanned or
  predicted treatment within six (6) months after
  enrollment and prior to completion of the 6-month
  follow-up.
• Lesions proximal and distal to the treatment site
  that are ? 50 DS
• Contralateral leg disease that requires treatment
  within the next 30 days and prior to completion
  of 30 day follow-up
• Cardiovascular surgical or cardiovascular
  interventional procedures (including, but not
  limited to, aortic, renal, cardiac, carotid,
  femoro-popliteal, and below the knee) within 30
  days prior to enrollment in this study and
• Perforation or dissection of grade C or greater
  seen during or after the creation of the pilot
  channel.

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Results

• Demographics
• 5 of 61 patients had popliteal procedures above
  the knee joint
• Average lesion length 56 mm
• Average reference vessel diameter 4.9 mm
• Average percent diameter stenosis pre-procedure
  was 78

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Safety

• Acute Patency (within 30 days)
• 59 of 61 (97) patients were patent by duplex
  Doppler ultrasound (2 patients had a PSV gt 2.0 on
  DUS at 30 days.)
• 61 of 61 (100) patients freedom from TVR and TLR
  at 30 days.
• No acute complications or re-interventions were
  reported.

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Efficacy

• Primary Efficacy Endpoint
• Reduction in diameter stenosis of greater than or
  equal to 20 by core lab assessment
• Greatly exceeded this endpoint with an average
  reduction of 35 and a lower confidence interval
  of 30

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Efficacy

• Other Efficacy Outcomes (per IFU)
• 60 of 61 (98) patients achieved a final residual
  stenosis of to 30 by physician assessment
• Angiographic Core lab mean percent stenosis
• Pre-procedure 78
• After Turbo-Booster 43
• Final 22

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Efficacy

• Clinical Efficacy Outcomes
• Average Rutherford Classification change of 2.4
  at baseline to 1.0 at 30 days
• Walking Impairment Questionnaire scores increased
  55 from 46.2 to 71.5 at 30 days
• ABIs increase from 0.78 at baseline to 0.97 at 30
  days

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• PATENT
• Photo-Ablation using the Turbo-booster and
  Excimer laser for iN-stent restenosis Treatment

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PATENT

• Study Milestones
• Prospective, non-randomized study
• Sample size 100 enrolled
• Up to 10 sites in Germany
• Follow-ups 1, 6 and 12 months post-procedure
• Duplex at 6 and 12 months
• Adverse events through 12 months

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• SALVAGE
• ProSpective Multi-Center TriAL to EValuate the
  Safety and Performance of the Spectranetics Laser
  with Adjunct PTAand GorE Viabahn Endoprosthesis
  for the Treatment of SFA In-stent Restenosis

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SALVAGE

• Sponsor VIVA Physicians (VPI)
• Funding Spectranetics and Gore

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SALVAGE

• Objective To evaluate the safety and
  performance of the Spectranetics laser used with
  the Gore Viabahn endoprosthesis for the treatment
  of SFA in-stent restenosis.
• Design Multi-center, prospective non-randomized
  registry with up to 100 patients at up to 15
  sites in US and EU.
• Primary Endpoint Duplex ultrasound at 12 months.
• Primary Safety Endpoints
• Stent integrity or migration at 12 months on
  X-ray.
• Major adverse event rate through 12 months
  defined as death, MACE, unplanned amputation and
  TVR.
• Secondary Endpoints TLR 12 months, ABI and WIQ
  1,6,12 months
• Technical Success for Laser Achievement of a
  3mm lumen with laser technology.

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Spectranetics Current Studies

• VIVA II Spectranetics Laser - Gore Viabahn PTFE
  Covered Stent
• Objective Assess patency at 12 months following
  the treatment of ISR by maximally debulking wit
  the 2.5 Turbo catheter followed by Viabahn
  stent-graft placement.
• Sponsor VIVA
• Study Design Multi-center prospective registry
  
• Long, diffuse SFA in-stent restenosis, Rutherford
  1-4
• Sample Size 120
• Sites 10
• Follow-up 12 month duplex doppler ultrasound
• Goal SPNC will consider using data to support a
  510(k) to expand CLiRpath indications to ISR.

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Laser Atherectomy

• Laser atherectomy offers effective treatment
  options for patients with specific lesion
  characteristics.

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WELCOME
Hilton Harrisburg, September 2007