Novel laser-based atherectomy catheter: Results from the Eximo Medical B-Laser™ IDE+EU Study

Marianne Brodmann, MD

Division of Angiology, Medical University Graz, Austria

Disclosure

Speaker name:

Marianne Brodmann, MD

I have the following potential conflicts of interest to report:

x Consulting

Medtronic, BD BARD, Spectranetics, Intact Vascular,

Soundbite Medical, Biotronik, Bayer, Daiichi Sankyo,

Böhringer Ingelheim, Astra Zeneca

B-Laser™ Atherectomy System• Small and light solid-state Nd:YAG laser

• No calibration and no warm-up time for laser system

• Indifferent to contrast media presence (Safety!)

• Three fold affinity to lesion type tissue vs artery’s endothelium (Safety!)

• 355 nm wavelength

• Short pulses (~10 ns) (Calcium!)

• ATK and BTK including calcified lesions, ISR, CTO

• Four OTW (0.014”) catheter sizes – 0.9mm, 1.5mm, 2.0mm and 2.35mm (fitting to 4F-7F sheaths)

• Aspiration capability (for the 2.0mm and 2.35 mm) to avoid emboli (Safety!)

• “Off-center” capability for large lumen creation and for non-concentric lesions (2.35mm)

EXIMO B-Laser™ offers a full line of laser catheters with unprecedented capabilities that open new market opportunities in PAD

B-Laser™ Line of Catheters

4

B-Laser™ catheters come

in a range of diameters

from 0.9 to 2.35mm

B-Laser™ Clinical Experience of IDE study and EU study (1)

• Studies Subjects: 147 subjects (160 lesions)

6 (IDE study) and 12 (Pilot study) month follow-up

• Sites 13 sites | 31 physicians | Used in both Hospital and OBL settings in the U.S. and EU

• Summarized Results Excellent clinical performance and safety profile

• EU study results publication is underway

• IDE acute and 30 days results publication was accepted by CRM Journal

• IDE entire study up to 6 months FU will be submitted soon

B-Laser™ Clinical Experience of IDE study and EU study (2)

• Studies were performed with a real world case mix including various lesion types, ATK and BTK, including ISR.

• B-Laser™ performance not impacted by calcification severity– EU Study:88% of subjects had some level of calcification; >60% were

moderate-severely calcified– IDE Study:77% of subjects had some level of calcification; >25% were

severely calcified

• Proven efficacy with subjects who suffered from Chronic Total Occlusion– EU Study: 79% had CTO lesions– IDE Study: 34.6% had CTO lesions & sub-total occlusions

B-Laser™ Clinical Experience of IDE study and EU study (3)

• None of the147 study subjects (97 IDE + 50 EU) experienced device-related complications that required intervention (zero perforation and no flow-limiting dissections), by CoreLab.

• None of the147subjects experienced perioperative distal embolization (by CoreLab) with only 8 EPD used.

• TLR at 6 months- 3 / 141 subjects (2.1%)

• TLR at 12 months- 2 / 46 (4.3%)

• Bailout stenting – 1 / 147 (0.7%) (not device related)

• MAE at 30 days- 1 / 147 (0.7%) (not device related)

B-Laser™ Clinical Experience of IDE and EU studies

88.1

53.8

16.4

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

Residual stenosis- IDE and EU* studies (n=159 lesions)

BL Post B-laser Post adjunctive therapy

34.2% reduction

*For EU study:

(1) Post adjunctive therapy was evaluated per the investigator and not per corelab.

(2) 2nd lesions (in 3 cases) were evaluated per the investigator and not per corelab.

B-Laser™ Clinical Experience of IDE and EU studies

*For EU study:

(1) Post adjunctive therapy was evaluated per the investigator and not per corelab.

(2) 2nd lesions (in 3 cases) were evaluated per the investigator and not per corelab.

88.0

100.0

88.090.1

53.8

62.9

54.858.1

16.4 15.918.1

16.4

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

General (n=159) CTO (n=64) ISR (n=20) Severe calcification (n=45)

Residual stenosis - general vs. CTO cases vs. ISR cases vs. severe calcification cases

BL Post B-laser Post adjunctive therapy

34.2% reduction

37.1%reduction

33.2% reduction

32% reduction

B-Laser™ Clinical Experience of IDE and EU studies- DUS

Note: Patency is defined by PSVR <2.5. For IDE it was determined by the

CoreLab, and for EU it was determined by site ultra-sonographers

97.3%

87.6%

80.0%

82.0%

84.0%

86.0%

88.0%

90.0%

92.0%

94.0%

96.0%

98.0%

100.0%

30D (n=111) 6M (n=113)

General patency rate - (IDE+EE studies)

Patency rates at 30D and 6 Months- Lesion type

97.3%

87.6%

100.0%96.7%

93.3%89.2%

94.4%

87.5%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

30D (n=111) 6M (n=113) 30d (n=29) 6M (n=30) 30D (n=30) 6M (n=37) 30D (n=18) 6M (n=16)

General Severely calcified CTO ISR

Patency rate by lesion type (IDE+CE studies)

Patency rates at 30D and 6 Months- Calcification level

95.8%

81.8%

94.9%

83.7%

100.0%

88.9%

100.0%96.7%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

30d (n=24) 6M (n=22) 30d (n=39) 6M (n=43) 30d (n=19) 6M (n=18) 30d (n=29) 6M (n=30)

No calcification Mild Moderate Severe

Patency rate by calcification level (IDE+CE studies)

IDE- Clinical Outcome (ABI, Rutherford, WIQ n= number of the same subjects that have BL, 30D and 6M clinical

outcome data)

14

22.8

45.0 44.0

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

BL 30D 6M

WIQ score (n=68)

Avg

. WIQ

sco

re0.7

1.00.9

0.0

0.2

0.4

0.6

0.8

1.0

1.2

BL 30D 6M

ABI (n=76)

Avg

. AB

I2.8

1.00.7

-0.5

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

BL 30D 6M

Rutherford (n=86)

Avg

. Ru

ther

ford

5cm CTO in SFA, 2.35mm with “off-centering”

Before After B-Laser™ After B-Laser™ + Balloon

B-Laser™ Clinical Experience- Typical

angiograph with “off -Centering”

IVUS images (1.5mm in 5.5mm vessel)

Before Laser After Laser

16

A lumen much larger than the nominal catheter diameter, was achieved

Thank You!

17

Novel laser-based atherectomy catheter: Results from the Eximo Medical B-Laser™ IDE+EU Study

Marianne Brodmann, MD

Division of Angiology, Medical University Graz, Austria