Mb angioplasty was performed by the flextome cutting balloon boston scientific, the angiosculpt scoring balloon angioscore, inc, or the scoreflex scoring balloon orbusneich medical, inc, hong kong. Wolverine coronary cutting balloon boston scientific. A noncompliant balloon with 34 microtomes mounted on its surface a semicompliant balloon with an external nitinol shape memory helical scoring edge. The flextome device contains a flex point every 5 mm along the length of the atherotomes cutting blades for greater flexibility and deliverability. Flextome monorail cutting balloon dilatation device with 3 atherotomes, 3. Boston scientificgalway flextome cutting balloon catheters, transluminal coronary angioplasty, percutaneous.
A novel scoring sheath for treatment of complex lesions. The lumen diameter late loss in the cutting balloon group was 0. Indepth repository for allied health care professionals. The flextome cutting balloon is available in diameter sizes ranging from 2. Succesful laser recanalization of the rca total occlusion using a 0. Deflate the cutting balloon very slowly by dialing down on the indeflator and then pulling a negative. The cutting balloon flextome cutting balloon, interventional. The cutting balloon device is a proven tool for the mechanical challenges of complex lesions that are often resistant to conventional balloon angioplasty. Ptca of the second obtuse marginal branch with a 2. Cutting balloon angioplasty is one of the common interventions for instent restenosis. A rare and serious unforeseen complication of cutting. Small peripheral flextome cutting balloon monorail microsurgical dilatation device class iia a m d. This procedure is different from rotoblation percutaneous transluminal rotational atherectomy or pcra whereby a diamond tipped device spins at high revolutions to cut away calcific chalky atheroma usually prior to coronary stenting. Boston scientifics flextome is the most widely used cutting balloon.
Given her ongoing chest pain and ischemia, the decision was made to proceed with pci. Treat challenging lesions with the flexible, deliverable and predictable flextome cutton balloon device. Contemporary approach to heavily calcified coronary. Images and case reports in interventional cardiology. Wolverine cutting balloon delivers industryleading performance with. Preload or insert overthewire pta balloon into the proximal xo score and advance the balloon to target site. 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. Cutting balloon angioplasty for treatment of spontaneous. Highspeed rotational atherectomy versus modified balloons. Scoring balloon catheter angiosculpt biotronikspectranetics semicompliant nylon balloon with an external nitinol shape memory helical scoring edge. A twocase series of entrapment of a ruptured balloon in. Angiosculpt scoring balloon catheter open access journals.
Flextome monorail cutting balloon dilatation device with 3 atherotomes, 2. B improvement of distal flow in diagonal artery after wiring with whisper wire. May 27, 2018 the compressive hematoma in the obtuse marginal artery was treated with a 3. A cutting balloon is an angioplasty device invented by barath et al. Focused force ptca with controlled dissections stent apposition improvement. Semicompliant balloon, dual wires exert focused inflation force. Cutting balloon has an advantage of better anchorage to slippery hyperplastic tissue over traditional ptca balloons.
Apex otw 40mm balloon catheters 2 34 flextome cutting balloon overthewire device flextome cutting balloon otw 6mm length 2 35 flextome cutting balloon otw 10mm length 2 35 flextome cutting balloon otw 15mm length 2 35 maverick overthewire balloon catheters maverick otw 9mm balloon catheters 2 37. Bfarm field corrective actions lot recall of flextome. Realworld application of bioresorbable vascular scaffold. Also the expanded blades of a cutting balloon can incise. Flextome cutting balloon boston scientific scoring balloon catheter. However, may need to go to higher pressure and or longer duration to achieve hemostasis.
The first aim is to prevent cardiac tamponade by immediate balloon inflation sds or the balloon present in the guide proximal or at site of perforation at the lowest pressure possible. Sep 21, 2018 flextome cutting balloon boston scientific angiosculpt scoring balloon biotronik scoreflex scoring balloon orbusneich medical rotablator boston scientific sirolimuseluting orsiro stent biotronik independent clinical event committee chair. Novel use of cutting balloon to manage compressive subintimal. Many doctors are using these as micro catheters as they are lower profile. Class 2 device recall flextome cutting balloon device. The 90% stenosed lesion was located in a severely calcified superficial femoral artery sfa. This procedure is different from rotoblation percutaneous transluminal rotational atherectomy or pcra whereby a diamond tipped device spins at high revolutions to cut away calcific. Successful angioplasty with intravascular ultrasound and. When the flextome cutting balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation.
The flextome cutting balloon boston scientific corporation has been shown to achieve better midterm patency compared to conventional pta for focal 30 mm lesions. Apr 03, 2015 the lesion was first treated using a 4. Flextome cutting balloon dilatation device boston scientific. Antegrade approach to stumpless chronic total occlusion of. It has practical bene ts over percutaneous transluminal coronary angioplasty ptca. It consists of a noncompliant balloon surrounded by three to four longitudinal microtomes or microsurgical blades deliv. Burst resistant patented balloon material that matches an nc on toughness. Various complications related to cutting balloon angioplasty have been reported including arterial rupture, delayed perforation and fracture of microsurgical blades. Balloon dilatation at the site where the burr was trapped 7 dislodge and withdraw of the burr 9 ivus assessment after rotablation 8 2nd rotational atherectomy with a 1. The flextome cutting balloon boston scientific, us is the latest incarnation of the original barath design fig. Class 1 device recall flextome cutting balloon device. The deliverability you need 47% improvement in recross recross pea kf o r ce g r a ms 35 30 25 20 15 10 cutting balloon ultra2 device flextome cutting balloon device 17.
The guideliner catheter for stent delivery in difficult. This process, referred to as atherotomyq3j, allows. Here we report a very unusual and inadvertent extraction of a stent previously deployed in the ramus intermedius coronary branch by. The ivus image showed that a small dissection had been made in the. Ferenc, bad krozingen, germany independent qca core lab isar research center, munich. The flextome device is available in lengths of 6, 10, and 15 mm and sizes of 2. The flextome cutting balloon boston scientific corporation has been shown to achieve better midterm patency compared to conventional pta for focal balloon catheter has been successfully used for.
The rotablator rotational atherectomy system, heart technology, acquired by boston scientific, was developed by david auth and was used in coronary arteries for the first time by jean louis fourrier in lille, on january 6, 1988. Pdf a rare and serious unforeseen complication of cutting. Oct 06, 2016 then this lesion was predilated with a 3. Case report a rare and serious unforeseen complication of. Hence a guideliner catheter was used, which allowed distal cutting balloon dilatation followed by implantation of 2. Role of lesion preparation in the treatment of bifurcation. Cutting balloons have also been used in the treatment of refractory or recurrent laryngotracheal stenosis, particularly in cases where a dense ring of circumferential fibrosis has formed in the trachea or either bronchus. The cutting balloon ultra2 is an older monorail device that has 30% less deliverability.
Usefulness of cutting balloon angioplasty prior to stenting. Immediate stent recoil in an anastomotic vein graft lesion. The tube and balloon are typically made of polymer materials and the cutting scoring elements are typically made of metal e. Flextome monorail cutting balloon dilatation device with 4 atherotomes, 3. Device has a larger profile than a conventional ptca catheter of the same nominal inflated. Vessel preparation with scoring balloons prior to dcb or stenting. Atherotome dislodgement and successful retrieval during. Novel use of cutting balloon to manage compressive.
We selected the size of cutting balloon and stent based on the lumen diameter and the external elastic membrane diameter obtained by ivus. Flextome cutting balloon catheter by boston scientific chocolate pta catheter by trireme. A rare and serious unforeseen complication of cutting balloon. Diverse content in the form of procedure videos, case studies, therapy presentations, recorded events, speaker sessions and webinars. Pdf peripheral cutting balloon 2cmperipheral cutting balloon 2cm. Nov 01, 2015 a cutting balloon takes advantage of the reduction in vessel stretch and injury by scoring the vessel longitudinally, rather than an uncontrolled disruption of the atherosclerotic plaque. Developed in the early 1990s, the cutting balloon has had considerable clinical application over the past two decades. Key features fast 5, 10, or 20second acquisitions at min. Usually 24 atmospheres for about 510 minutes is sufficient. Oct depicted a welldilated culprit lesion and no significant dissected lesion. A slightly longer 10 mm cutting balloon was chosen for additional penetration of the tissue outside the stent. This led to complete resolution of the intramural haematoma with only very minimal residual intimal dissection on oct figure 4b. It has a special balloon tip with small blades, that are activated when the balloon is inflated.
D normalized final timi3 flow into distal diagonal artery, with residual intimal dissection. A type 2 scad of diagonal artery with complete occlusion arrow and timi0 flow. Vessel preparation with scoring balloons prior to dcb or. Rotational atherectomy was designed to debulk lesions and assist in the delivery of stents to the distal location. While removing the flextome monorail balloon catheter from the introducer sheath, one of the atherotomes fractured. High pressure balloon powerflex, cordis, fremont, usca cutting balloon flextome cutting balloon, boston scientific, natick usma focal force balloon advance enforcer, cook medical, bloomington usin paclitaxel coated pta balloon 3 minute aperto, cardionovum gmbh, bonn d lutonix, bard pv, tempe usaz. Pci instent restenosis accuforce ptca balloon catheter. Succesful ptca of the bifurcation of om2 branch and circumflex using a 2. It was reported that during a pediatric cardiac treatment procedure, an atherotome fracture occurred. The flextome cutting balloon device consists of a balloon with 3 or 4 atherotomes microsurgical blades mounted longitudinally on its outer surface. The ivus image showed that a small dissection had been made in the proximal ra, but the maneuver failed to loosen the entry point tissue figure 2d.
Class 2 device recall boston scientific, flextometm. A second ofdi was then performed, which showed a significant improvement of the luminal area figure 4. Three inflations were performed 7, 7, and 10 atmospheres. The size of the final balloon used was chosen in a 1. Contemporary approach to heavily calcified coronary lesions. Without dialing down, the cutting balloon may wing and resistance may be felt while retrieving it into the guide catheter. Successful treatment of a spontaneous right coronary.
Jun 18, 2016 the cutting balloon ultra2 is a monorail device, and the flextome cutting balloon boston scientific, natick, ma has two catheter designs fig. Flextome cutting balloon boston scientific was then introduced and inflated at 6 atm. Balloon catheters 3 cutting balloon 4 guidewires 5 guide catheters 6 angiographic catheters 7 embolic protection 8 ivus 9 atherectomy devices 10 accessory products 1 stents interventional cardiology ordering information 2 ordering information interventional cardiology dincar2583ea the complete model number must be indicated for ordering. Successful treatment of a spontaneous right coronary artery. Chocolate trireme medical scoring balloon catheter. Flextome cutting balloon dilatation devices by boston. Cutting balloons dilate while reducing elastic recoil4 and allowing more plaque. Developed in the early 1990s, the cutting balloon has had. Combination of drugcoated balloon angioplasty and excimer.
Cutting across geographies, expertise and experience levels to offer therapy based learning content. Xo score diamond sheath xo scoretm is shown for educational purposes only and is not fda or ce mark cleared at this time. Pdf balloon angioplasty typically injures the vessel wall by. Vscaffolding of coronary bifurcation lesions using. Cutting balloon angioplasty cba is one of the adept ways of treating instent restenosis. Oct assessment of cutting balloon angioplasty for instent. Vascular access was obtained through the femoral artery. The intravascular ultrasound ivus catheter is introduced to the. A noncompliant balloon with 34 microtomes mounted on its surface. A twocase series of entrapment of a ruptured balloon in the. Jun 19, 2008 the cutting balloon does not need to be rotated into a different position to perform multiple inflations. Lot recall of flextome cutting balloon monorail microsurgical dilatation device and small peripheral cutting balloon monorail microsurgical dilatation device, boston scientific pdf, 101kb, file does not fully comply with accessibility standards.
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