About Peripheral Artery Disease
Peripheral Artery Disease (PAD) is characterized by fatty build up that blocks normal blood flow in the arteries and has become an increasingly common diagnosis in the US.1 Approximately 8 million people in the United States have PAD.2 Terumo Interventional Systems offers a unique suite of products to meet the special challenges of PAD cases, particularly those involving the difficult to access lower extremities. Our products have been specifically developed in collaboration with leading physicians, and are designed to be easy to use. These devices provide reliable access, navigation through tortuous vessels, lesion crossing, and treat diseased areas, which may help save limbs and improve lives.
In the United States, approximately 600,000 endovascular procedures were performed on lower limbs in 2014; these procedures are projected to increase to almost 1 million by 2020.3 Individuals with diabetes are at greater risk for severe PAD and are 10-30 times more likely to have an amputation.4 There is a 1- year post-amputation mortality rate of 50% for PAD-related lower extremity amputations.5
Symptoms of PAD include claudication, which is pain in the leg (typically calf or thigh) after walking. Some patients develop pain after just a few steps, while others can walk further distances before pain forces them to stop. Procedures to treat PAD may take place Above-the-Knee (ATK) or Below-the-Knee (BTK), and a more severe form of PAD is called Critical Limb Ischemia (CLI).
Above-the-Knee (ATK) disease resides from the descending aorta, continuing through the iliac and femoral (CFA & SFA) arteries, and ends at the popliteal artery. A variety of treatment options are available, including low invasive modes like exercise, diet, or drugs, while more invasive approaches include endovascular procedures (plain old balloon angioplasty (POBA), stenting, atherectomy), surgical bypass, and amputation. Multiple factors influence the treatment decision including number of vessel runoff(s), condition of the lower leg, calcification and lesion type, and age. Typically, 0.035" systems are most used in this area, though 0.018" and 0.014" devices may be used.
Below-the-Knee (BTK) disease resides from the popliteal artery, continuing through the tibial (anterior, posterior, peroneal) artery, and ending at the dorsalis pedis artery. Treatment options include endovascular procedures (e.g., stenting6,*, POBA7, atherectomy7), surgical bypass, and amputation. Age, lesion type, patient condition, and comorbidities influence treatment pathway choice, with more severe factors requiring more intensive treatment. Typically, 0.014" and 0.018" devices are most used this area.
*Currently not approved for use in the US for BTK.
Critical Limb Ischemia (CLI)
Critical Limb Ischemia (CLI) is an advanced form of PAD caused by a significant obstruction of the arteries that decreases blood flow to the extremities (hands, legs, feet) and has progressed to the point of severe pain and skin ulcers or open sores. CLI is a precursor to a more serious condition known as gangrene.
Each year, 160,000 to 180,000 amputations are performed in the United States due to CLI. Since 1985, the amputation rate has increased from 19 to 30 per 100,000 persons each year, with a 4- to 5-fold increase in those over the age of 80. Additional facts about amputation related to CLI include8:
- Overall, fewer than half of all CLI patients achieve full mobility after an amputation, and only one of four Above-the-Knee amputees will ever wear a prosthetic (artificial) limb.
- 30 to 40 percent of all amputees will undergo a second limb amputation within three to five years of their first amputation.
- The 30-day mortality (death) and morbidity (complication) rates after an amputation remain high, ranging from 4 to 30 percent for death and from 20 to 37 percent for morbidity.
There is an alternative to amputation when medical therapy and self-care are no longer effective in staving off the progression of CLI. An increasing number of medical centers are using the latest minimally invasive interventional procedures for limb revascularization that offer several distinct advantages for selected lesions.9,10
TERUMO delivers a portfolio of tools for PAD treatment:
PINNACLE PRECISION ACCESS SYSTEM® is a micro access kit specifically designed for smooth and reliable vascular access through calcified or scarred arteries. The unique design of the PINNACLE PRECISION ACCESS SYSTEM® helps to achieve smooth, atraumatic vascular access; smooth guidewire-to-dilator and dilator-to-sheath transitions allow for easy access.
The PINNACLE® DESTINATION® guiding sheath provides consistent reliability for interventional and diagnostic challenges. A variety of lengths, French sizes, and tip shapes are available to meet procedural needs.
The GLIDEWIRE® portfolio provides a comprehensive set of guidewires covering a range of lengths, diameters, tip shapes, wire types, and angles specifically designed to reach, cross, and help deliver therapies. This broad portfolio includes the GLIDEWIRE ADVANTAGE® and GLIDEWIRE® GOLD guidewire product lines.
The NAVICROSS® support catheter is designed to help physicians complete procedures successfully. NAVICROSS® delivers unmatched performance in pushability, as well as excellent wire support, torque control, crossing profile, and kink resistance. A range of lengths and tip shapes are available.
The comprehensive TERUMO PTA balloon dilatation catheter portfolio is compatible with a range of wire sizes (METACROSS® 0.035”, CROSSTELLA™ 0.018”, CROSPERIO™ 0.014”) and systems (Over-the-Wire (OTW) and Rapid Exchange (RX)) supporting the physician's choice in peripheral procedures.
The MISAGO® RX Self-expanding Peripheral Stent provides a therapeutic solution to help keep arteries open with unique design features. A range of stent lengths and diameters are offered for sale.
Indication for MISAGO® Peripheral Stent
The MISAGO Self-expanding Peripheral Stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic lesions or occlusions of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery with reference vessel diameters ranging from 4mm to 7mm and lesion length up to 150mm.
Important Safety Information
Do not use this device in pregnant patients who exhibit angiographic evidence of severe thrombus in the target vessel or lesion site before/after undergoing Percutaneous Transluminal Angioplasty (PTA) procedure, patients with contraindication to antiplatelet and/or anticoagulation therapy, patients who are judged to have a lesion that prevents proper placement or deployment of the stent, a lesion that is within an aneurysm or an aneurysm with a proximal or distal segment to the lesion, or a lesion through which a guide wire cannot pass. This device should only be used by a physician who is familiar with, and well trained in, Percutaneous Transluminal Angioplasty (PTA) techniques and stent implantation.
RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.
- About Peripheral Artery Disease (PAD). American Heart Association website. http://www.heart.org/HEARTORG/Conditions/More/PeripheralArteryDisease/About-Peripheral-Artery-%20Disease-%20%20%20PAD_UCM_301301_Article.jsp#.V9sEB_krKUk Updated March 23, 2016. Accessed September 22, 2016.
- Peripheral Arterial Disease (PAD) Fact Sheet. Centers for Disease Control and Prevention website. http://www.cdc.gov/DHDSP/data_statistics/fact_sheets/fs_PAD.htm Updated June 16, 2016. Accessed September 22, 2016.
- Millennium Research Group. 2015. Peripheral Vascular Devices US 2015 Market Analysis RPUS11PV14 Page 98.
- Tentolouris N, Al-Sabbagh S, Walker MG, et al. Mortality in diabetic and nondiabetic patients after amputations performed from 1990 to 1995: a 5-year follow-up study. Diabetes Care. 2004 Jul;27(7):1589-604. http://dx.doi.org/10.2337/diacare.27.7.1598
- Fortington LV, Geertzen JH, van Netten JJ, et al. Short and long term mortality rates after a lower limb amputation. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):124-31. http://dx.doi.org/10.1016/j.ejvs.2013.03.024
- Bosiers M, Deloose K, Callaert J. Drug-eluting stents below the knee. J Cardiovasc Surg (Torino). 2011 Apr;52(2):231-4.
- Diamondback 360® Peripheral Orbital Atherectomy System. Cardiovascular Systems Inc. website. http://www.csi360.com/products/diamondback-360-peripheral-orbital-atherectomy-system Accessed September 22, 2016.
- Critical Limb Ischemia and Amputations: A Growing Problem. Vascular Disease Foundation’s Keeping in Circulation. Summer 2009;9(3):5-6.
- O’Keeffe ST, Woods BO, Beckmann CF. Percutaneous transluminal angioplasty of the peripheral arteries. Cardiol Clin. 1991 Aug;9(3):515-22.
- Isner JM, Rosenfield K. Redefining the treatment of peripheral artery disease. Role of percutaneous revascularization. Circulation. 1993 Oct;88(4 Pt 1):1534-57.