Attached files
| file | filename |
|---|---|
| EX-99.1 - EXHIBIT 99.1 - SPECTRANETICS CORP | ex991linciglobalpressrel.htm |
| 8-K - 8-K - SPECTRANETICS CORP | a20168klincpressrelease.htm |
Prof. Thomas Zeller
Department of Angiology
University Heart Center Freiburg-Bad Krozingen
Bad Krozingen, Germany
On behalf of Dr. Andrew Holden, Prof. Yann Gouëffic and the
ILLUMENATE Global Investigators
ILLUMENATE Global Study
Stellarex DCB
Disclosures
Speaker Name: Prof. Thomas Zeller
I have the following potential conflicts of interest to report:
Consulting: Medtronic, Bard, Biotronik, Trireme, Spectranetics,
Boston Scientific
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
x
ILLUMENATE Global Study Overview
Prospective, multi-center, single-arm, study
Patients will be followed for up to 5 years
Same rigorous data collection process as
randomized trials, independent adjudication by:
• Angiographic Core Laboratory1
• Duplex Ultrasound Core Laboratory2
• Clinical Events Committee
• Data Safety Monitoring Board
Monitoring with 100% source data verification
1.Beth Israel Deaconess Medical Center, Boston, MA
2.VasCore, Boston, MA
ILLUMENATE Global Study Overview
Study Objective: Assess safety and performance
of the Stellarex DCB in the SFA and/or popliteal
arteries
Primary Safety Endpoint: Freedom from device-
and procedure-related death through 30 days and
freedom from target limb major amputation and
CD-TLR through 12 months
Primary Effectiveness Endpoint: Primary patency
at 12 months (defined as PSVR ≤ 2.5 and no CD-
TLR)
5
Study Device: Stellarex DCB
Stellarex (2 µgr/mm2)
DCB Comp. A (3.5 µgr/mm2)
DCB Comp. B (2.0 µgr/mm2)
Arterial Pharmaco-Kinetics [1]
PTX particulate loss after transit [2]
• Low dose (2 μg/mm2) paclitaxel
• Hybrid-crystalline formulation
Spectranetics Proprietary
open-folded coating technology
1. Superimposed PK curves from different datasets: R.Melder, EuroPCR 2012; Yazdani et.al.
Catheterization and Cardivascular Interventions 83:132-140 (2014); data on file at Spectranetics
2. Number of particulates ≥10µm/mm of DCB length lost during transit. Data on file at Spectranetics
• Effective drug tissue transfer and
residency (≥ 28 days)
• Limited drug loss
Key Patient Eligibility Criteria
Inclusion Criteria
• Rutherford class 2, 3 or 4
• SFA and/or popliteal (down to
trifurcation)
• Has at least one patent run-off
below-the-knee
• 1 or 2 target lesion(s) with
cumulative length ≤ 20 cm
• Target vessel reference diameter
4-6 mm
Exclusion Criteria
• Acute or sub-acute thrombus in
target vessel
• Significant inflow disease not
successfully treated
• In-stent restenosis
• Severe calcification that
precludes adequate PTA
treatment
• Use of adjunctive therapies (i.e.
debulking or plaque incision)
Baseline Patient Characteristics
N (patients) 371
Age 68.2 ± 9.3 (371)
Male 73.0% (271/371)
Diabetes 33.7% (125/371)
Body Mass Index 27.0 ± 4.2 (368)
Hypertension 79.5% (295/371)
Hyperlipidemia 74.7% (277/371)
Previous or Current smoker 81.9% (304/371)
Previous coronary revasc. 33.4% (124/371)
Renal insufficiency 7.0% (26/371)
Previous intervention of
lower limb
42.3% (157/371)
ABI 0.70 ± 0.20 (347)
RCC 1
0.3%
RCC 2
33.4%
RCC 3
57.7%
RCC 4
6.2%
RCC 5
2.4%
Baseline Rutherford Classes
Baseline Angiographic Characteristics
Per Core Lab assessment
N (lesions) 417
De novo1 94.0% (392/417)
Lesion Length (cm) 7.5 ± 5.3 (413)
Total occlusions 31.3% (129/412)
Calcification
None/Mild 43.0% (173/402)
Moderate 16.2% (65/402)
Severe calcification 40.8% (164/402)
Minimum lumen diameter (mm) 0.96 ± 0.87 (412)
Reference vessel diameter (mm) 4.87 ± 0.84 (412)
Baseline diameter stenosis (%) 80.3 ± 17.4 (412)
Eccentric Lesion 60.4% (249/412)
1. Site reported
Prox
SFA
11%
Mid SFA
42%
Distal
SFA
33%
Prox
Pop
9%
Mid Pop
4%
Distal
Pop
1%
Lesion Location
Procedural Characteristics
Pre-dilatation1 98.1% (409/417)
Post-dilatation1 28.3% (118/417)
Provisional stent1 17.3% (72/417)
Stent Due to Dissection1 8.65% (36/417)
Post-DCB Dissections
Grade D
Flow-limiting (Grade E or F)
19.7% (81/416)
0.2% (1/416)
Post-DCB MLD (mm) 3.43 ± 0.80 (407)
Post-procedure Diameter Stenosis (%) 24.7 ± 11.8 (409)
Lesion Success2 97.6% (399/409)
1. Site-reported data
2. Lesion success- Final residual %DS ≤ 50% (per angiographic core lab), after using the DCB
Summary statistics are based on non-missing data
Key Safety Endpoints
Freedom from Primary Safety Event: 94.8%*
All-cause mortality through 12 Months*: 0.6% (2/355)
Cause of both deaths was cancer
CD-TLR rate through 12 months*: 6.2% (22/354)
Primary Safety Events
Device- or procedure-related death 0
Major target limb amputation 1**
Clinically-driven TLR 19
* Per KM estimate at day 365
** Major target limb amputation in subject who was RCC 5 at baseline, following a CD-TLR
*Through day 395, The denominator includes subjects with an event or those without an event having
follow-up on or past the opening of the follow-up window.
Freedom From CD-TLR*
by Clinical Events Committee Adjudication
* Defined as revascularization associated with PSVR ≥ 2.5 or >50% stenosis via angiogram and worsening of RCC by more than
1 or ABI decrease of >0.15 from the maximum early post-procedure level, that is clearly referable to the target lesion
94.8% @ day 365
Day 0 30 180 360 365 395
At Risk 371 367 357 240 204 72
Event 0 3 7 19 19 22
Survival (%) 100 99.2 98.1 94.8 98.4 91.2
360
Primary Patency
by Duplex Core Lab Evaluation
Primary Patency defined as freedom from Duplex derived restenosis (PSVR ≤ 2.5) and clinically-driven TLR
81.4% @ day 365
Day 0 30 180 360 365 395
At Risk 417 411 398 260 217 70
Event 0 5 14 51 65 84
Survival (%) 100 98.8 96.6 86.6 81.4 69.1
360
1. Lyden S. Oral presentation, TCT 2016, Washington DC. Nov 2, 2016.
2. Brodmann M. Oral presentation. AMP Symposium, Chicago, IL, Aug 10, 2016
3. Laird JR et al. J Am Coll Cardiol 2015;66:2329-38, P.Krishnan Oral Presentation. VIVA 2016
4. Rosenfield K, Jaff MR, White CJ, et al. The New England Journal of Medicine. 2015;373(2):145-153.
[1] [2] [3]
12-Month Patency Rates
Data in Context with Core Lab* Adjudicated Trials
[4]
Core lab adjudicated (VasCore, Boston, MA) Duplex-derived Primary Patency
based on PSVR ≤2.4 (▪) or ≤2.5 (ם), KM survival estimates at 360 (†) or 365 (‡) days.
▪† ▪‡ ם ‡ ם ‡ ם‡
similar lesion
characteristics
1. Lyden S. Oral presentation, TCT 2016, Washington DC. Nov 2, 2016.
2. Brodmann M. Oral presentation. AMP Symposium, Chicago, IL, Aug 10, 2016
3. French National Commission of Medical Device Evaluation on IN.PACT SFA (May, 3rd 2016) - http://www.has-sante.fr/portail/jcms/c_2635037/fr/in-pact-admiral
4. K.Rosenfield et al. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med 2015
1 3
12-Month CD-TLR and Ca++
Data in Context with Core Lab Adjudicated Trials
similar lesion
characteristics
CD-TLR rates are reported as proportions through the full 12 month follow-up period
[1] [2] [3] [4]
0% 0.3%
34.8%
56.3%
6.5%
2.1%
61.1%
19.2%
12.1%
6.8%
0% 0.9%
RCC 0 RCC 1 RCC 2 RCC 3 RCC 4 RCC 5
Baseline
12 Months
Key Secondary Outcomes
Rutherford Classification*
*analysis includes patients with RCC data at baseline and 12 months (n=339)
P<0.001
90.3% of subjects had an
improvement in
Rutherford class at 12
months compared to
baseline
32.1
60.7
0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0
Baseline
12 Months
Composite WIQ Score
Baseline
12 Months
83.6% of subjects had
an improvement in
their WIQ score at 12
months compared to
baseline
P<0.001
*analysis includes patients with WIQ data at baseline and 12 months (n=317)
ILLUMENATE Global Conclusions
• ILLUMENATE Global demonstrated a 12-month Primary patency
of 81.4% and CD-TLR rate of 6.2%
• Data support and reinforce previous findings from ILLUMENATE
Pivotal trial in a similarly high (>40%) severe calcium patient
cohort
• Builds on the robust ILLUMENATE program with 4 trials, >1000
patients
• Confirms low dose next-gen DCB can outperform within a wide
range of patient complexities