DURABLE SAFETY AND EFFICACY OUTCOMES LEAVING NOTHING BEHIND

1,2

Revolutionary Below-the-Knee (BTK) Treatment for Chronic Limb-Threatening Ischemia (CLTI) in Conjunction with Drug-Coated Balloon (DCB)

SPUR RETRIEVABLE SCAFFOLD THERAPY

A self-expanding scaffold with integrated dilation balloon catheter designed for controlled penetration and lesion preparation through a series of radially expandable spikes. Spur creates channels that modify the lesion morphology, decreasing the recoil effect and changing vessel compliance. Channels optimize drug uptake when used with a commercially available drug-coated balloon (DCB).

Retractable shaft—6F sheath compatible

Spikes optimized for controlled penetration and lesion preparation

Integrated balloon system for improved conformability

Radiopaque markers for visibility

.014″ guidewire

Familiar pin-and-pull Spur deployment system

3.0mm and 4.0mm device diameters conform to vessel anatomy

RST Mechanism of Action

Track Spur system to lesion site and deploy using pin-and-pull method.

Inflate integrated balloon in a controlled fashion.

RADIAL SPIKES PENETRATE THE VESSEL WALL AND CREATE CHANNELS DESIGNED TO:

modify lesion morphology to change vessel compliance and reduce vessel recoil, and
enhance drug absorption.

Scaffold provides temporary supportive structure.

Deflate the balloon and recapture the Spur system.

Treat lesion with any commercially available DCB.

Durable safety and efficacy outcomes leaving nothing behind.

FAMILIAR PIN-AND-PULL SPUR DEPLOYMENT SYSTEM

Clinically Proven

MAXIMIZING BTK TREATMENT OUTCOMES WITHOUT COMPROMISING ON SAFETY

DEEPER OUS

Prospective, multicenter, single-arm, performance goal comparator

12-MONTH RESULTS¹

Patency of
lesions (DUS)

Freedom from
MALE

Freedom from
CD-TLR

RUTHERFORD SCORE IMPROVEMENT

58.4%

improvement in mean Rutherford score from the baseline

WOUND SIZE REDUCTION

63.1%

Reduction

STUDY DEVICES
Spur + paclitaxel-coated DCB*

STUDY SIZE

107 patients enrolled
10 centers (EU + NZ)

BASELINE LESION
CHARACTERISTICS

21% total occlusions
21% moderately/severely calcified lesions

92.7mm (60-240mm)

mean Spur-treated length (range)

DEEPER LIMUS

Prospective, single-center, pilot, single arm

12-MONTH RESULTS²

Patency of
lesions (DUS)

Freedom from
MALE

Freedom from
CD-TLR

RUTHERFORD SCORE IMPROVEMENT

68.2%

subjects improved to Rutherford classification 0

WOUND SIZE REDUCTION

54.0%

Reduction

STUDY DEVICES
Spur + sirolimus-coated DCB**

STUDY SIZE

26 patients enrolled
1 center (Austria)

BASELINE LESION
CHARACTERISTICS

37% total occlusions

97mm (60-210mm)

mean Spur-treated length (range)

VESSEL RECOIL

Occurrence of vessel recoil

Defined as lumen compromise
≥10% at 15 minutes post
Spur treatment

Clinical Validation

23 patients; Dominican Republic

Prospective, single-center, first-in-human, single-arm

Spur + Lutonix DCB

Mean Spur Treated Length: 113mm (67.2-158.8)

6 mo. patency (PP): 88.9%
Freedom from POD at 30 days: 100%
Freedom from CD-TLR & amputation at 12 months: 94.1%

Abbreviations: DCB, drug-coated balloon; DUS, duplex ultrasound; MALE, major adverse limb event; POD, perioperative death; PP, primary patency.

107 patients: Europe, New Zealand

Prospective, multicenter, single-arm, performance goal comparator

Spur + paclitaxel DCB

Mean Spur Treated Length: 92.7mm (60-240)

6 mo. patency: 85.7%
12 mo. patency: 74.4%
Freedom from MALE and POD at 30 days: 100%
Freedom from MALE at 12 months: 98.9%

Occurrence of vessel recoil: <43% (defined as lumen compromise ≥10% at 15 min. post Spur treatment)

Abbreviations: DCB, drug-coated balloon; DUS, duplex ultrasound; MALE, major adverse limb event; POD, perioperative death; PP, primary patency.

26 patients; Austria

Prospective, single-center, pilot, single-arm

Spur + sirolimus DCB

Mean Spur Treated Length: 97mm (60-210)

6 mo. patency: DUS 91.3%
12 mo. patency: DUS 89.5%
Freedom from MALE and POD at 30 days: 96.2% Freedom from MALE at 6 and 12 months: 96.0% & 95.5%

Occurrence of vessel recoil: <43% (defined as lumen compromise ≥10% at 15 min. post Spur treatment)

Abbreviations: DCB, drug-coated balloon; DUS, duplex ultrasound; MALE, major adverse limb event; POD, perioperative death; PP, primary patency.