From: The Design of an Improved Force Focused Angioplasty Catheter Date of download: 11/7/2017 Copyright © ASME. All rights reserved. From: The Design of an Improved Force Focused Angioplasty Catheter J. Med. Devices. 2013;8(1):011007-011007-5. doi:10.1115/1.4025852 Figure Legend: (a) An image of a 5.0 mm diameter Boston Scientific peripheral cutting balloon is shown in the inflated position. (b) In this schematic the structure of an inflated cutting balloon is highlighted. The microblades are embedded within a polymer base, and subsequently the polymer base is bonded onto the surface of an angioplasty balloon.

From: The Design of an Improved Force Focused Angioplasty Catheter Date of download: 11/7/2017 Copyright © ASME. All rights reserved. From: The Design of an Improved Force Focused Angioplasty Catheter J. Med. Devices. 2013;8(1):011007-011007-5. doi:10.1115/1.4025852 Figure Legend: The data presented in this bar chart relates to a search performed within the FDA MAUDE database, the brand name entered was “cutting balloon” and the time period ranged from Jan. 1, 2011 to Dec. 31, 2011. A total of 115 records were retrieved and analyzed. Twenty-four events were removed from the data, as the adverse event occurred outside the body. Please note that this data only represents devices that have an adverse event associated with them and has been reported to the FDA, this proportion of cases represented a small minority of cutting balloons used in the U.S. in 2011.

From: The Design of an Improved Force Focused Angioplasty Catheter Date of download: 11/7/2017 Copyright © ASME. All rights reserved. From: The Design of an Improved Force Focused Angioplasty Catheter J. Med. Devices. 2013;8(1):011007-011007-5. doi:10.1115/1.4025852 Figure Legend: (a) The image above details our elastomeric sheath with concealed blades seated between two protuberances, on this device five blades are equally distributed about the circumference of the sheath. (b) In this image the sheath is illustrated in the expanded configuration, the internal lumen has been enlarged and subsequently the sheath stretches and the protuberances are reduced in height exposing the blades. Moreover, the sheath stores elastic energy in this expanded configuration.

From: The Design of an Improved Force Focused Angioplasty Catheter Date of download: 11/7/2017 Copyright © ASME. All rights reserved. From: The Design of an Improved Force Focused Angioplasty Catheter J. Med. Devices. 2013;8(1):011007-011007-5. doi:10.1115/1.4025852 Figure Legend: (a) The total length of the mesh/blade arrangement is depicted in this image, while in (b) a close-up of the method that the blades integrate with the NiTi mesh is depicted. The upper blade details how the blade interacts with the upper surface of the mesh, while the blade is continuous below the mesh and cannot pass through the mesh. The small posts on the blade can be plastically deformed around the NiTi mesh for stability. The image in (c) shows a cross section with all five blades present. Please note the balloon and the sheath have been removed from this illustration to ensure the reader can identify the interaction between the blade and mesh.

From: The Design of an Improved Force Focused Angioplasty Catheter Date of download: 11/7/2017 Copyright © ASME. All rights reserved. From: The Design of an Improved Force Focused Angioplasty Catheter J. Med. Devices. 2013;8(1):011007-011007-5. doi:10.1115/1.4025852 Figure Legend: (a) Results of the simulated concentric calcified lesion test. Average values are displayed above the bars, and our force focused angioplasty balloon has a statistically significant lower burst pressure in comparison to a standard angioplasty balloon (p < 0.05).

From: The Design of an Improved Force Focused Angioplasty Catheter Date of download: 11/7/2017 Copyright © ASME. All rights reserved. From: The Design of an Improved Force Focused Angioplasty Catheter J. Med. Devices. 2013;8(1):011007-011007-5. doi:10.1115/1.4025852 Figure Legend: A plot of the comparative withdrawal resistance for the Boston Scientific cutting balloon and our force focused angioplasty balloon. There is a noticeable jump in the withdrawal resistance the wings of the Boston device are pulled into the introducer catheter, this is associated with the initial steep rise in force on the Boston Scientific curves. The experiment was repeated four times.

From: The Design of an Improved Force Focused Angioplasty Catheter Date of download: 11/7/2017 Copyright © ASME. All rights reserved. From: The Design of an Improved Force Focused Angioplasty Catheter J. Med. Devices. 2013;8(1):011007-011007-5. doi:10.1115/1.4025852 Figure Legend: Images of our device and Boston Scientific's cutting balloon (pre-inflation (row (i)), during inflation (row (ii)), and postdeflation (row (iii)). The positions A, B, and C are associated with the crossing profile measurements obtained.

From: The Design of an Improved Force Focused Angioplasty Catheter Date of download: 11/7/2017 Copyright © ASME. All rights reserved. From: The Design of an Improved Force Focused Angioplasty Catheter J. Med. Devices. 2013;8(1):011007-011007-5. doi:10.1115/1.4025852 Figure Legend: (a) Depicts microdamage associated with our device, while image (b) depicts microdamage associated with Boston Scientifics cutting balloon device. These histology images demonstrate that the mechanism of action with both devices is comparable. The microblade damage is highlighted as the area encompassed by the black circles.