In the modified-balloon group, the most frequently used device was the AngioSculpt Scoring Balloon (AngioScore), followed by the Scoreflex Scoring Balloon (OrbusNeich Medical) and the Flextome Cutting Balloon (Boston Scientific). The related CPT® codes are 92920-+92944. • Angioplasty utilizes a balloon to dilate a ^hemodynamically significant vessel stenosis. Designed specifically to address long, diffuse lesions commonly found in infrainguinal arteries, the AngioSculpt PTA scoring balloon catheter offers 360˚ of precise and effective dilatation. AngioSculpt’s smart scoring balloon technology delivers a unique combination of controlled, effective dilatation and predictable device safety. AngioSculpt’s smart scoring balloon technology delivers a unique combination of controlled, effective dilatation and predictable device safety. A cutting balloon is an angioplasty device invented by Barath et al. vs. focal), predominance of neotinima vs. neoatherosclerosis, number of stent layers, prior stent expansion and apposition, presence/absence of stent fracture, and presence/absence of intra- and/or extra stent calcium. The AngioSculpt Scoring Balloon Catheter is comprised of a semi-compliant angioplasty balloon surrounded by a nitinol scoring element. 2. BUT, these specialty balloons can be very difficult to deliver • If you do not get full balloon expansion, move quickly to laser. The AngioSculptX Drug-Coated PTCA Scoring Balloon Catheter is built on the trusted AngioSculpt scoring balloon platform and is designed for lumen gain through controlled dissection with enhanced drug delivery. The tube and balloon are typically made of polymer materials and the cutting/scoring elements are typically made of metal [e.g., nickel-titanium alloy (Nitinol)]. Plaque modification balloons (Angiosculpt, Cutting balloon, Chocolate balloon, Section 30.9.3 ), although delivery can be challenging through heavily calcified lesions. We then delivered a 4.0 mm Wolverine Cutting Balloon and inflated it to maximal 12 atm throughout the lesion. After inflation with the Wolverine balloon, IVUS showed that the MLA had improved to 4 mm 2, confirmed on angiography (Figure 3). *Please refer to product labeling, including the Instructions For Use, to select the appropriate device size. Coronary Intervention. Developed in the early 1990s, the cutting balloon has had considerable clinical application over the past two decades. Google Scholar | Crossref | Medline From scoring balloon technology to laser atherectomy, we offer a range of solutions to cross, lase and sculpt compromised vessels. Additional planned coronary interventions for a non-target lesion within 9 months of the study procedure. We have applied AngioSculpt on severe calcified lesions to achieve … 2. Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. CUtting Balloon versus Conventional Balloon Angioplasty. Additional lesion preparation: cutting balloon This was examined in the Cutting Balloon Global Randomized trial of 1238 patients. This trial found no difference in the rates of restenosis at 6 months (31% vs 30%, p = 0.75) for cutting balloons vs POBA and there was a greater rate of perforation (0.8% vs 0%, p = 0.03) with cutting balloon … Purpose: To prospectively determine whether cutting balloon angioplasty, when compared with conventional balloon angioplasty (CBA), improves morphologic and clinical outcome in patients with femoropopliteal in-stent restenosis. Cutting balloon. A cutting balloon is an angioplasty device invented by Barath et al. used in percutaneous coronary interventions. It has a special balloon tip with small blades, that are activated when the balloon is inflated. Appropriate vessel preparation may significantly improve short and long-term outcomes. The charts include sizes, configurations, and unique characteristics of each product, listed alphabetically by manufacturer name. The results of the right renal artery stenting were assessed with digital subtraction angiography through the 6 … A non-compliant balloon with 3-4 microtomes mounted on its surface A semi-compliant balloon with an external Nitinol shape memory helical scoring edge. 5 In this process, two coronary guidewires are passed into the distal vessel and a balloon advanced to the site of the lesion abutting the uncrossable segment. •Angiosculpt •Chocolate •Cutting balloon (only short lesions, better outcome than PTA) •Intravascular lithotripsy •No published data on Scoreflexand VascuTrak(only SFA) PoncyljuszW et al, CVIR 2013;36:1500-1507 The idea is to provide controlled predictable scoring of the artery wall to allow better dilatation with the semi compliant balloon. The AngioSculpt® scoring balloon catheter (AngioScore Inc., Fremont, Ca) is an alternative to the cutting balloon. AngioSculpt Scoring Balloon Catheter ® (AngioSculpt; AngioScore Inc., Fremont, CA, USA) can produce more ‘scoring’ marks, which leads to prevention of ‘plaque shift’ and ‘balloon slippage’; moreover, the ‘scoring’ produces some cutting effect, leading to successful stent implantation even on severe calcified lesions. YOU CAN TRUST THE DELIVERY. A new angioplasty scoring balloon catheter (AngioSculpt®) has recently been approved for the treatment of narrowings in coronary arteries. Rotational atherectomy was performed using Rotablator (Boston Scientific). J Invasive Cardiol. The scoring balloon contains a flexible nitinol scoring ribbon with three rectangular spiral struts to incise the atheromatous plaque at pressures up to 18 atmosphere (atm). 2008;15:283-291. Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions. Materials and Methods: Patients with symptomatic femoropopliteal in-stent restenosis were randomly assigned to undergo CBA or peripheral cutting balloon … The unique design of the WOLVERINE Cutting Balloon combines a proprietary atherotome and low pressure balloon design to directly address each of these complications. High pressure venoplasty with 10.0 × 40 mm Dorado Balloon and 6.0 × 40 mm angiosculpt. Laser angioplasty ELCA – precise plaque removal Infrequently used (high cost, lack of benefit over PCI alone) Adjunctive method for debulking 15. Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring. Results: The technical success rates were similar between the cutting balloon (100%) and high-pressure balloon (97.1%) groups. The balloon’s proprietary nitinol constraining structure creates “pillows” and “grooves” that are designed to provide predictable, uniform, and atraumatic dilatation. 45. The Cutting Balloon (Boston Scientific) is designed with 3 or 4 microtome blades attached to the balloon in order to score the plaque during balloon inflation. The size of the final balloon used was chosen in a … 3. Resolute Onyx DES is composed of a single-wire strand formed into a continuous sinusoidal waveform, providing a fluid range of motion with greater flexibility and conformability when compared to laser-cut stents. This includes use of a compliant or non-compliant balloon, a cryoplasty balloon or a cutting balloon • Atherectomy is performed utilizing photoablation (laser), rotational (Rotoblater, Diamondback Orbital) or directional cutting (Silver Hawk) devices This is a single-use device. After stenting, balloon postdilation was performed for all treated lesions in both groups, with the mean maximum postdilatation pressure slightly higher in the RA group (21.3 ± 2.8 vs 20.1 ± 0.7 atm, P < .001). Possible advantages: - Focused force PTCA with “Controlled” dissections - Stent apposition improvement. ... Observations from the anterior and posterior body outline is scored with blades (cutting balloon) or wires (angiosculpt) allows the child from reaching the pouch, and the notch on the diameter of aortic dilatation. 26. 25. 2008;20:21-27. Intervention: 6F vs. 7F Access: Femoral Retrograde Femoral Antegrade Brachial BTK Retrograde (PT/AT/Pop) Wires 0.035 vs. 0.018 vs. 0.014 “Safe, Stiff, Slippery, Sharp” Reentry Devices Balloons Standard PTA balloon Scoring/Cutting balloon Intravascular Lithotripsy (Shockwave) Drug-Coated balloon … Front-cutting mechanical atherectomy for treating mixed morphologies with low risk of embolization5 AngioSculpt scoring balloon Reduces risk of flow-limiting dissections, including calcified lesions4 Stellarex drug-coated balloon Durable treatment effect with a low-drug dose in common to complex patients; only DCB reporting A proposed advantage of this nitinol edge is improved device flexibility and deliverability. Angiosculpt Scoring balloon catheter – semicompliant balloon with nitinol spiral cage Low crossing profile (2.7F) More flexible alternative to cutting balloon 14. Testing was performed on AngioSculpt catheters to determine how the Pass Inflation Pressure diameter of a balloon varies with applied inflation pressure. Pre-dilatation with AngioSculpt yielded 33% - 50% greater luminal gain than direct stenting or pre-dilatation with a conventional angioplasty balloon. Accutane before and afters for nexium vs prilosec vs prevacid. used in percutaneous coronary interventions.It has a special balloon tip with small blades, that are activated when the balloon is inflated. The device is typically placed using a guidewire and guiding catheter, and its balloon is inflated by the infusion of liquid through it tubular body. The 2020 NCCI manual, Chapter XI, Section I.14, lists stent placement (putting a small tube in the artery to keep it open), atherectomy (removing plaque from a blood vessel), and balloon angioplasty (inflating a tiny balloon at the blockage site to widen the area) as types of PCI. Traditional balloon angioplasty can result in complications like vessel dissection, poor luminal gain, lesion recoil, balloon slippage, and poor stent apposition. Rectangular laser-cut nitinol electropolished Helical configuration For 2.0-3.5 mm diameter balloons Angiosculpt ≤1.0 Ref vessel diameter For 4.0-8.0 mm diameter balloons Angiosculpt 0.5 mm less than Ref vessel diameter Angiosculpt Balloon The AngioSculpt PTA scoring balloon catheter offers 360˚ of precise and effective dilatation. Rasuli, P, Chennur, VS, Connolly, MJ, et al. Angiosculpt. It consists of a semicompliant balloon with an external nitinol shape-memory helical scoring edge. The AngioSculpt balloon (AngioScore, Inc, Fremont, Calif) is another scoring device approved for peripheral vascular use. The prevalence, treatment and outcomes of balloon undilatable chronic total occlusions (CTOs) have received limited study. ing focused wire cutting of the arterial vessel wall.4-6 Scoring, Cutting, or Nitinol-Framed PTA Balloons A scoring balloon with nitinol wires wrapped around the balloon (AngioSculpt scoring balloon catheter, Spectranetics, a Philips company) (Figure3B), or a cutting balloon with parallel cutting blades (Wolverine cutting balloon dilation device, AngioSculpt really delivers Advanced technology delivers big results Nitinol-enhanced balloon deflation for excellent rewrap and recross capabilities. 4.0mm balloon RVD* 4.5mm and up 5.0mm balloon -¥ RVD* 5.5mm and up 6.0mm balloon RVD* 6.5mm and up To optimize dilatation results: Step wise inflation For example, hold for approximate 20 seconds in between every 2 atm pressure increase *RVD = Reference Vessel Diameter J Interv Cardiol. • Angiosculpt • Chocolate • Cutting balloon (only short lesions, better outcome than PTA) • No published data on Scoreflex and VascuTrak Poncyljusz W et al, CVIR 2013;36:1500-1507. • Transluminal coronary balloon angioplasty (92920 – 92921) • Transcatheter placement of intracoronary stent (92928 – 92929) • Transcatheter coronary atherectomy (92924 – 92925) • Transcatheter coronary atherectomy plus stent placement (92933 – 92934) • Revascularization of or through a coronary artery bypass (92937 – 92938) Although the rotoblator is the device of choice in the management of these lesions, one alternative is the use of balloons that cut the plaque, such as the cutting balloon or the AngioSculpt balloon. The AngioSculpt PTCA scoring balloon catheter is an essential tool in the treatment of a wide range of coronary lesions, including in-stent restenosis (ISR) and type C lesions. It crossed easily and was inflated to the rated maximal pressure of 12 atm. These devices have smaller crossing profiles and more flexibility than the cutting balloon. Results: Although the balloon size and the maximal dilation pressure for pre-dilatation was larger (3.33 ± 0.28 vs 3.09 ± 0.33 mm, p = 0.01) and higher (11.6 ± 3.2 vs 8.6 ± 2.7 atm, p Purpose: The aim of this study was to determine the influence of lesion preparation using the dual wire scoring balloon on stent expansion and long-term outcomes. The scoring balloons (AngioSculpt; Spectranetics, Colorado Springs, Colorado, USA, and ScoreFlex, OrbusNeich, Hong Kong) are semicompliant balloons surrounded by external nitinol spiral scoring wires. A balloon angioplasty, also called a percutaneous transluminal coronary angioplasty (PTCA), involves the use of a thin tube (catheter) that is inserted into a blocked or narrowed artery. In 1991, Barath and colleagues developed a noncompliant cutting balloon with three or four microblades fixed radially to it. Scoring Balloon Catheter. The results were (Balloon Compliance) used to establish the labeled compliance values. The RESCUT trial 7 established the benefit of cutting-balloon PTA in reducing balloon slippage and the need for unplanned stenting in ISR lesions. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. This unique mechanism of action aims at providing improved acute and long term outcomes while leaving nothing behind. Randomized trial comparing the primary patency following cutting versus high-pressure balloon angioplasty for treatment of de novo venous stenoses in hemodialysis arteriovenous fistulae. restenosis/occlusion (66.7% vs 37.5%) (Gandini et al., 2013) and one retrospective study of atherectomy and DCB of de novo lesions in comparison with atherectomy in combination with plain balloon angioplasty (86.7% vs 56.9%) (Kokkinidis et al., 2018). Balloon Devices Angiosculpt POBA Cutting Balloon PolarCath Balloon . The device, the AngioSculpt (ASC) scoring balloon catheter (AngioScore, Fremont, CA), incorporates a laser‐cut highly flexible nitinol scoring element containing three spiral struts which encircle a semi‐compliant conventional balloon catheter to create focal concentration of the dilating force along the edges of the scoring element. be developed was the cutting balloon (Flextome® Cutting Balloon, Boston Scientific, MA, USA). 5. J Endovasc Ther. An extension of this technique is the use of a second wire to modify resistant lesions in the so-called wire cutting technique as described by Hu et al. After cutting balloon angioplasty, the primary lesion patency rates were 100% (35/35), 88.6% (31/35), and 71.4% (25/35) at 1 month, 3 months, and 6 months, respectively. Cutting Balloon vs. POBA Comparison of Patency Rates for SFA and Popliteal Artery Lesions SFA Popliteal Artery PTA (%) CBA (%) P PTA (%) CBA (%) P Patency at 6 months Primary 92.7 93.7 0.42 88 92.3 0.05 Results: Severe dissections were fewer (8.8% vs 29.7%, p=0.027) and the total dissection length was shorter (11.5±12.8 vs 35.7±24.1 mm, p=0.027) in the NSE group. were balloon undilatable (12%). 4 Depending on balloon size, the cutting force at the blade edges is estimated to be augmented … The AngioSculpt Scoring Balloon Catheter combines the safety and effectiveness required of a new technology with the simplicity and versatility of a high-performance balloon catheter. BIOTRONIK is the distributor of AngioSculpt on behalf of Angioscore/Spectranetics. Loading... Balloon undilatable CTOs were longer In some cases, lesion preparation requires the use of different systems. Proximal optimization technique (POT) was performed in 60% and 62% among SCB and RA groups, respectively. Perhaps in dissection after PTCA, if lesion did not open, chocolate balloon may be preferred over cutting balloon. Product. However, they are based on experience with very limited cases and formal patency data is insufficient. Several techniques were used for lesion preparation, such as high-pressure balloon inflations (64%), rotational atherectomy (31%), laser (21%), cutting balloon (15%), and AngioSculpt (Spectranetics, Fremont, CA, USA) (14%) (Table 4). TurboHawk LX ‘venous atherectomy’. Treating DES Restenosis • Use longer balloons so they don’t slip as much • Consider Wolverine, AngioSculpt and Chocolate balloons taken to high pressures. The ISAR DESIRE IV trial evaluated use of the AngioSculpt scoring balloon (Spectranetics Corporation) versus a standard PTA balloon for predilation prior to application of a DCB in ISR lesions. Objectives: To evaluate the technical success, safety and patency of cutting balloon angioplasty for the treatment of resistant dialysis access stenoses. AngioSculpt Test Plan ST-1197 (2008), on file at AngioScore, Inc. 4. Welcome to the online edition of Endovascular Today’s 2012 Buyer’s Guide. Drug Eluting Devices Drug Eluting Stents Drug Eluting Balloon . From Which Medical Device. The MB balloon had a mean diameter of 2.94±0.34 mm, a mean length of 10.59±2.33 mm, and was inflated at a mean pressure of 15.6±3.0 atm. Total lesions 907 (3.0 L/patient) Bellow the knee 406 lesion (1.9 L/patient) Paclitaxel-coated balloons have shown promise in reducing access-related restenosis in small trials. Fonseca A, Costa JR, Abizaid A, et al. 1 Wu et al, Comparison of Cutting Balloon versus High-Pressure Balloon Angioplasty for Resistant Venous Stenoses of Native Hemodialysis Fistulas, JVIR, 2008, 19: 877-883 2 Aftab et al, Randomized Clinical Trial of Cutting Balloon Angioplasty versus High-Pressure Balloon Angioplasty in Hemodialysis Arteriovenous Fistula Stenoses Resistant to Conventional Balloon Angioplasty, JVIR, 2014, 25: 190-198 The same principle of action is the basis of the atherotomy balloon catheters (Cutting Balloon and AngioSculpt balloon). In the MB group, the Angiosculpt scoring balloon was the most frequently used device (83.8%), followed by the Scoreflex scoring balloon (12.9%) and the Flextome cutting balloon (3.3%). The Flextome Cutting Balloon is available in diameter sizes ranging from 2.0 to 4.0 mm (in 0.25 mm increments) and lengths of 6, 10 or 15 mm. The catheter has a tiny balloon on its tip that is inflated to push plaque against the artery's walls to widen the path for blood flow. More stents and longer average stent length were presented in the RA group. AngioSculpt® Scoring Balloon Catheter. Cutting Balloon, or investigational coronary devices. A trial comparing cutting balloon vs. conventional balloon angioplasty of de novo native coronary lesions Primary endpoints 6-month major acute coronary events (MACE) Conclusion There is a lower re-stenosis rate with cutting balloon angioplasty than with conventional angioplasty As outlined above, ISR treatments have much higher TLF rates compared to … Most SCRIPPS CLINIC often I use the 0.09” laser set at 80/80 with contrast injections. Coronary Artery Disease is the leading cause of death among men and women. - Product Code NWX. We attempted to deliver an AngioSculpt scoring balloon (Philips) but it would not cross the lesion, so we switched out for a 3.5 mm Wolverine Cutting Balloon (Boston Scientific). The new AngioSculpt® RX PTCA Scoring Balloon Catheter features an advanced molded, tapered tip that facilitates reliable catheter delivery. It consists of a noncompliant balloon surrounded by three to four longitudi-nal microtomes (or microsurgical blades) deliv- My personal experience has shown that cutting balloon does better job of scoring the plaque compared to chocolate balloon or Angiosculpt. Angiosculpt (FIM) Scheinert D et al, Cath Cardiovasc Interv 2007;70:1034-1039. Possible disadvantages: Mean patient age was 65610 years and most patients were men (84%). https://www.frontiersin.org/articles/10.3389/fcvm.2020.558129 Patients with balloon undilatable CTOs were more likely to be diabetic (67 vs. 41%, P<0.001) and have heart failure (44 vs. 28%, 50.027). Cutting Balloon Ultra Flextome Cutting Balloon. J Am Coll Cardiol. Single-wire design. Cutting Balloon (Boston Scientific), the AngioSculpt Scoring Balloon (AngioScore, Inc), or the Scoreflex Scoring Balloon (OrbusNeich Medical, Inc, Hong Kong). October 12th, 2007 Medgadget Editors Cardiology, Radiology. The firm name on the label is Spectranetics Corporation, Fremont, CA. A 1-year limb salvage rate of 85.9% was reported by Ansel in 73 patients undergoing peripheral interventions utilizing a Cutting Balloon, with a low adjunctive stenting rate of 20% for severe dissection and inadequate dilatation. 2010 Jun;23(3):240-8. doi: 10.1111/j.1540-8183.2010.00547.x. After PSM, a total of 174 pairs were enrolled. The lesion could be expanded. Background Restenosis remains a problem in hemodialysis access interventions. Atherectomy Devices CSI 360 Orbital Atherectomy Turbo-Laser Silver Hawk Rotablator . Cutting Balloon as compared to standard balloons.8 ANGIOSCULPT The AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) was first developed in 2003 for the treatment of complex coronary artery dis-ease.9 It has subsequently been evaluated for the treat-ment of infrapopliteal disease and CLI and more recent- Left ventricular ejection fraction < 35%; 20 A recent meta-analysis showed that 6-month target lesion patency was significantly higher in the percutaneous cutting balloon arm compared to with conventional and high-pressure balloon angioplasty (67.2 vs. 55.6%; 95% CI, 0.05–0.19; P < 0.05) . Intravascular ultrasound assessment of the novel AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary lesions. This was driven by the need for 16 crossovers in the modified balloon group, most commonly because of uncrossable (n = 8) or undilatable (n = 6) lesions, vs … Balloon angioplasty (ideally using noncompliant balloons at high pressure, Chapter 9 : Lesion Preparation). Intravascular lithotripsy via 7.0 × 60 mm balloon at the level of mid left femoral vein with total of 180 pulses. The use of more than 1 balloon was allowed. Thirty-four patients were treated with 3 inflations of an NSE balloon and 37 patients were treated with a conventional balloon. Cutting balloon versus conventional balloon angioplasty in short femoropopliteal arterial stenoses. 44. This Buyer’s Guide offers a searchable, comprehensive listing of the FDA-approved interventional devices available in the United States. balloon expandable stent was advanced through the sheath and positioned across the stenosis at the origin of the low right renal artery. 2001 Sep;38(3):672-9. Cutting balloon, angiosculpt, ultra high-pressure balloons. Venoplasty with 7.0 × 20 mm cutting balloon finally yielded the lesion 19 The Cutting Balloon has also been reported to be superior to plain-old balloon angioplasty in peripheral arterial bypass graft stenosis. Cutting balloon 3.0 mm, 20atm 1 Additional pre dilatation: Cutting balloon 3.0 mm, 26atm 2 Considering severely calcified lesions, pre-dilatation with cutting balloon at high pressure was additionally attempted. – Smooth transitions throughout the distal end of the catheter for improved crossing – The most agile and nimble AngioSculpt design ever – Elevates procedural confidence. Diameter vs. Scoring Balloons The primary hypotheses for our multicenter trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared with conventional angioplasty for treatment of … Description. 3. It was hypothesized that the discrete longitudinal incisions created during balloon inflation might improve the success of conventional balloon angioplasty by reducing elastic recoil and minimizing intimal injury, thereby minimizing the subsequent neointimal proliferative response. 4 Better final luminal dimensions (p < 0.001) 4 89% of the vessels predilated with AngioSculpt had final stent area ≥ 5.0 mm 2 compared to 74% for direct stenting or pre-dilatation with a conventional balloon. The patient returns with diffuse in-stent restenosis of distal left SFA/popliteal artery. We examined the prevalence, clinical and angiographic characteristics, and procedural outcomes of percutaneous coronary In rotational atherectomy plaque is ground by a high speed concentrically rotating tip (burr). The stent was deployed to 12 atmospheres of pressure. The semi compliant nature allows the balloon to be sized for the vessel. Vaquerizo B, Serra A, Miranda F, Triano JL, Sierra G, Delgado G, Puentes A, Mojal S, Brugera J. Balloons, Guides, Wires • Core products for the Interventional cardiology community • Each product is critical to the ultimate success of the procedure • They are used in every case and in many cases several balloons and wires will be utilized • Enhancements to these products occur regularly and help advance the field. J Vasc Interv Radiol 2015; 26(12): 1840 – 1846. Angiosculpt (FIM BTK) A single-stent technique was used in most lesions (68% vs. 75%; ), and in around one-third of cases, an intervention in the side branch with balloon dilatation or kissing-balloon inflation was necessary (36% vs. 38%; ). Plain balloon angioplasty has traditionally been used to treat lower limb arterial disease but can be limited by significant residual stenosis, vessel recoil, dissection, and by late restenosis. The Only DES Designed from a Single Wire †. Background: Cutting balloon angioplasty has been proposed to be useful in treating resistant dialysis access stenoses. Adamian M, Colombo A, Briguori C, Nishida T, Marsico F, Di Mario C, Albiero R, Moussa I, Moses JW. The AngioSculpt Scoring Balloon Catheter is an essential tool for the treatment of both coronary and peripheral artery disease.
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