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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)

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)

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., POBA6, atherectomy6), 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.

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 include7:

  • 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.8,9

 

TERUMO delivers a portfolio of tools for PAD treatment:

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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.

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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.

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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.

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Manufactured with TERUMO Glide Technology™, GLIDECATH Hydrophilic Coated Catheters are your first choice peripheral hydrophilic catheters for unrivaled selectivity and navigation.

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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.

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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.

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A more efficient alternative to manual compression, active closure devices help to achieve hemostasis much more rapidly and without added staff assistance.10-13 Our ANGIO-SEAL® Vascular Closure Devices have been proven to help patients reach ambulation earlier, allowing them to be discharged sooner.14

Indications
The Angio-Seal Vascular Closure Device product family, including the STS Plus, VIP and Evolution platforms, is indicated for use in closing and reducing time to hemostasis of the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8 F Angio-Seal device and a 6 French or smaller procedural sheath for the 6 F Angio-Seal device. The Angio-Seal STS Plus, VIP and Evolution platform devices are also indicated for use to allow patients who have undergone diagnostic angiography to safely ambulate as soon as possible after sheath removal and device placement, as well as to allow patients who have undergone an interventional procedure to safely ambulate after sheath removal and device placement.

Important Safety Information
Possible adverse events for vascular closure devices include, but are not limited to: bleeding or hematoma, AV fistula or pseudoaneurysm, infection, allergic reaction, foreign body reaction, inflammation or edema. This device should only be used by a licensed physician (or other health care professional authorized by or under the direction of such physician) possessing adequate instruction in the use of the device, e.g., participation in an Angio-Seal physician instruction program or equivalent.

RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use. 

References:

  1. 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 May 17, 2017. Accessed September 9, 2017.
  2. 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 9, 2017.
  3. Millennium Research Group. 2015. Peripheral Vascular Devices US 2015 Market Analysis RPUS11PV14 Page 98.
  4. 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
  5. 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
  6. Diamondback 360® Peripheral Orbital Atherectomy System. Cardiovascular Systems Inc. website. http://www.csi360.com/products/diamondback-360-peripheral-orbital-atherectomy-system  Accessed October 2, 2017.
  7. Critical Limb Ischemia and Amputations: A Growing Problem. Vascular Disease Foundation’s Keeping in Circulation. Summer 2009;9(3):5-6.
  8. Goodney PP, Tarulli M, Faerber A, Schanzer A, Zwolak R. Fifteen-Year Trends in Lower Limb Amputation, Revascularization, and Preventive Measures Among Medicare Patients. JAMA Surg. 2015 Jan 1; 150(1): 84–86. doi:  10.1001/jamasurg.2014.1007
  9. Isner JM, Rosenfield K. Redefining the treatment of peripheral artery disease. Role of percutaneous revascularization. Circulation. 1993 Oct;88(4 Pt 1):1534-57.
  10. Marso, S. P., Amin, A.P., House, J. A., Kennedy, K. F., Spertus, J. A., Rao, S. V., ... Rumsfeld, J.S. (2010). Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. Journal of the American Medical Association303(21), 2156-2164.
  11. Resnic, F. S., Blake, G. J., Ohno-Machado, L., Selwyn, A. P., Popma, J. J., & Rogers, C. (2001). Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. American Journal of Cardiology, 88(5), 493-496.  
  12. Vaitkus, P.T. (2004). A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention. Journal of Invasive Cardiology, 16(5), 243-246. 
  13. Arora, N., Matheny, M. E., Sepke, C., & Resnic, F. S. (2007). A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. American Heart Journal, 153(4), 606-611.
  14. ANGIO-SEAL® STS Plus, ANGIO-SEAL® VIP and ANGIO-SEAL® Evolution™ Instructions for Use.