dc319069b9cd65bf8c467de8ae7cfcc22b17ed22

 

Expanding endovascular interventions with:

  • Low, 4 Fr. profile
  • Additional access solutions
  • 60cm shaft options

 

The Diamondback 360® Peripheral Orbital Atherectomy System available in versions:

  • Diamondback 145cm Shaft; 1.25mm Micro Crown
  • Diamondback 145cm Shaft; 1.25mm Solid Crown
  • Diamondback 60cm Shaft; 1.25mm Micro Crown
  • Diamondback 60cm Shaft; 1.25mm Solid Crown

 

Redefining minimally invasive

4 Fr. sheath compatibility

  • Smaller sheaths are associated with fewer bleeding complications and reduced closure time1,2,3

Creating tibiopedal access solutions with 60cm devices

Expanding the endovascular interventional market and providing more treatment options

  • 4 Fr. sheath compatibility
  • Shorter, 60cm shaft for more convenient tibiopedal access

OAS Outperforms Balloon Angioplasty in Below-the-Knee (BTK) Lesions5

Excellent acute performance in patients with critical limb ischemia

 

CALCIUM 360º STUDY

Randomized, multicenter, prospective BTK study comparing OAS to balloon angioplasty alone in calcified lesions

Orbital Atherectomy System outperforms balloon angioplasty in BTK lesions enabling:

  • Lower balloon inflation pressure
  • Lower bail-out stent rate
  • Statistically significant difference in freedom from major adverse events* at 12 months

*Major adverse events: major amputation (above-the-ankle), death and TLR/TVR

 

WHAT ABOUT STEALTH?

These Diamondback 360® Systems are the first in the low profile family that leverage the Stealth 360® System’s OAS technology and sleek electric handle design.


References

1. Buchler JR, Ribeiro EE, Falcao JL, et al. A randomized trial of 5 versus 7 French guiding catheters for transfemoral percutaneous coronary stent implantation. J Interv Cardiol. 2008 Feb;21(1):50-5. Epub 2007 Dec 17.

2. Doyle BJ, Timg HH, Bell MB, et al. Major Femoral Bleeding Complications After Percutaneous Coronary Intervention. JACC: Cardio vascular Interventions. 2008;1(2):205-207.

3. Metz D, Meyer P, Touati C, et al. Comparison of 6F with 7F and 8F guiding catheters for elective coronary angioplasty: results of a prospective, multicenter, randomized trial. Am Heart J. 1997 Jul;134(1):131-7.

4. CSI Data on File

5. Shammas, N.Lam R, Mustapha J, et al. Comparison of Orbital Atherectomy Plus Balloon Angioplasty vs Balloon Angioplasty Alone in Patients with Critical Limb Ischemia: Results of the CALCIUM 360 Randomized Pilot Trial. J Endovascular Ther, 2012; 19:480-488.

 

Caution: Federal law (USA) restricts this device to sale by, or on the order of, a physician. The CSI Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. Contraindications for the system include use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.