Unmet Clinical Need

Every year the number of lower limb Percutaneous Transluminal Angioplasty (PTA) procedures performed increases, and there is an ongoing battle to improve patient safety ⁽¹⁾. According to SAGE Group “in 2010 almost 18 million U.S. citizens suffered from PAD. Reflecting the aging population, this number is projected to increase to 21 million by 2020.” ⁽²⁾

The longer life expectancy and increase in diabetes prevalence influences the number of cases treated each year and their complexity, producing a higher volume of high risk patients. Lower limb PTA is also performed on increasingly complex patients with multiple co-morbidities and severe forms of Peripheral Arterial Disease (PAD) ⁽³⁾. In these patients with already-compromised lower limb arteries, minimizing the risk of potential complications is a necessity. This is leading to physicians choosing more aggressive therapeutic approaches such as atherectomy and thrombectomy.

One of the major complications of any PTA procedure is the distal embolization of debris ⁽⁴⁾. In the very worst cases, distal embolization can totally occlude an artery, potentially leading to lower limb amputation ⁽⁵⁾. In other cases, smaller pieces of debris can embolize directly into arterioles or capillaries, resulting in sub-acute symptoms that nevertheless potentially compromise medium to long term outcomes.  

The risk of distal embolization during lower limb angioplasty is real, yet other than PROTEUS, there are no FDA-cleared devices for embolic capture and removal for use in lower limb angioplasty ⁽⁶⁾. To fill this unmet need, Angioslide has developed the first of its kind: the PROTEUS™ device.  

PROTEUS™ is a unique Embolic Capture Angioplasty™ (ECA) device that combines standard balloon angioplasty with debris removal capabilities through its suction mechanism. The PROTEUS device has the same physical and behavioral characteristics as a standard angioplasty balloon such as inflation time, deflation time, pushability, and crossing profile, but with the added feature of debris capture and removal.

Angioslide's PROTEUS™ device addresses this unmet clinical need by enabling physicians to perform standard balloon angioplasty and at the same time improve their patient's safety.

1. Allie, D. To PROTECT or Not to PROTECT? In Lower Extremity Angioplasty Procedures, ‘‘Why Not?’’ Is the Question! J ENDOVASC THER. 2008;15:277–282
2. SAGE Group, 2010 Sep, New Estimates for PAD in the US
3. Baril  DT, Marone LK, Kim J. Outcomes of endovascular interventions for TASC II B and C femoro-popliteal lesions. J Vasc Surg. 2008. Sept 48(3):627-33.
4. Burns BJ, Phillips AJ, Fox A, Boardman P, Phillips-Hughes J. The Timing and Frequency of Complications After Peripheral Percutaneous Transluminal Angioplasty and Iliac Stenting: Is a Change from Inpatient to Outpatient Therapy Feasible? Cardiovasc Intervent Radiol (2000) 23:452–456.
5. Hasson JE, Acher CW, Wojtowycz M, McDermott J, Crummy A, Turnipseed WD. Lower extremity percutaneous transluminal angioplasty: multifactorial analysis of morbidity and mortality. Surgery. 1990 Oct;108(4):748-52.
6. www.fda.gov/MedicalDevices . 2009.