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PROTEUS

Clinical Need


The incidence of symptomatic emboli range from 1.5% to 25% and reach even higher rates following atherectomy or thrombolytic de-clotting procedures.
1


Large embolic loads can occlude key downstream vessels, consequentially resulting in re-interventions such as a thrombectomy, overnight thrombolysis, surgical revisions or even limb loss.
2

According to Davies
(2010) , over 50% of patients with clinically significant DE suffered from either deterioration or no change in symptoms following endovascular intervention.3


Physicians using the PROTEUS™ device can now capture and remove embolic particles (debris, thrombus) while performing angioplasty, d
uring Infrainguinal interventions, using the same device.


What is the PROTEUS™ device?

PROTEUS is a stand-alone angioplasty device that uniquely combines the dual functionality of balloon angioplasty and embolic capture and removal features. PROTEUS is indicated for lower limb arteries: femoral, iliac, ilio-femoral, popliteal, tibial, peroneal and profunda. It is first of its kind to receive FDA clearance for lower limb percutaneous angioplasty.

 

2-in-1 - How does the PROTEUS™ device work?

PROTEUS works just like an angioplasty balloon with the same physical and behavioral characteristics, such as inflation time, deflation time, pushability, and crossing profile. In addition, PROTEUS embolic capture feature involves a single-use suction mechanism that works through inward folding of the balloon, which creates negative pressure within the capture cavity for debris capture and removal. The reduced pressure in the capture cavity causes some of the particles that are released during the procedure to flow into the cavity for containment and removal.






PROTEUS™ is a standalone angioplasty device that does not require the use of additional disposables, making it uniquely cost-effective.


PROTEUS™ - Clinical Evidence

PROTEUS safety and efficacy was demonstrated in the multi center trial (MC-LEADER).

Histological analysis of the removed embolic particles, during the MC-LEADER, confirmed atheromatous material, acute thrombus, chronic thrombus, and neointima.



  1. Wholey  M.  The  Role  of  Embolic  Protection  in  Peripheral  Arterial  Atherectomy.  Tech  Vasc  Interv Radiol. 2011 Jun;14(2):65-74.
  2. Shammas NW, Shammas GA, Dippel EJ, Jerin M, ShammasWJ. Predictors of distal embolization in peripheral percutaneous interventions: a report from a large peripheral vascular registry. J Invasive Cardiol. 2009 Dec;21(12):628-31.
  3. Davies MG, Bismuth J, Saad WE, Naoum JJ, Mohiuddin IT, Peden EK, Lumsden AB. Implications of in situ thrombosis and distal embolization during superficial femoral artery endoluminal intervention.  Ann Vasc Surg. 2010 Jan;24(1):14-22.

 

For more information about the MC-LEADER trial, see our Clinical Data section.

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