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21 protocols using resolute integrity

1

Improved Balloon Catheter Pushability

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Example 3

The pushability of the balloon catheter in accordance with the disclosed subject matter prepared as described above was tested and compared to known balloon catheters including the Synergy II® (commercially available from Boston Scientific), Promus Premier® (commercially available from Boston Scientific), and Resolute Integrity® (commercially available from Medtronic). Pushability (i.e., push efficiency) was tested by applying a known force to the proximal end of a catheter placed in a tortuosity fixture over a guide wire (simulating a tortuous anatomy) and measuring how much of this force is transmitted to the distal end of the catheter. Higher ratios of distal force over proximal force indicate higher pushability. The results of the testing are shown in FIG. 17, which shows the pushability of the catheter. As depicted, catheters in accordance with the disclosed subject matter having a hypotube with a stepped skive in combination with a zero transmission (i.e., monolithic) inner member unexpectedly provide improved pushability as compared to commercially available catheters. For example, the catheter in accordance with the disclosed subject matter provided up to 33% improved pushability than commercially available catheters, which can improve delivery of the catheter to, including time needed to reach, the target site in a patient.

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2

Improved Distal Tensile Strength of Balloon Catheters

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Example 4

The strength of distal outer member in accordance with the disclosed subject matter prepared as described above was tested and compared to known balloon catheters including the Synergy II® (commercially available from Boston Scientific), Promus Premier® (commercially available from Boston Scientific), and Resolute Integrity® (commercially available from Medtronic). Distal outer member strength was tested by applying a tensile force to determine the strength of the distal section of a device. Higher force values indicate a higher distal tensile strength. The results of the testing are shown in FIG. 18, which shows that catheters in accordance with the disclosed subject matter having a single layer necked PEBAX® 72D outer member unexpectedly provide improved strength as compared to commercially available catheters. For example, the catheter in accordance with the disclosed subject matter was up 21% stronger than commercially available catheters, which can provide improved strength in navigating complex anatomy and reduce the likelihood of rupture/failure.

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3

Improved Balloon Catheter Pushability

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Example 3

The pushability of the balloon catheter in accordance with the disclosed subject matter prepared as described above was tested and compared to known balloon catheters including the Synergy II® (commercially available from Boston Scientific), Promus Premier® (commercially available from Boston Scientific), and Resolute Integrity® (commercially available from Medtronic). Pushability (i.e., push efficiency) was tested by applying a known force to the proximal end of a catheter placed in a tortuosity fixture over a guide wire (simulating a tortuous anatomy) and measuring how much of this force is transmitted to the distal end of the catheter. Higher ratios of distal force over proximal force indicate higher pushability. The results of the testing are shown in FIG. 17, which shows the pushability of the catheter. As depicted, catheters in accordance with the disclosed subject matter having a hypotube with a stepped skive in combination with a zero transmission (i.e., monolithic) inner member unexpectedly provide improved pushability as compared to commercially available catheters. For example, the catheter in accordance with the disclosed subject matter provided up to 33% improved pushability than commercially available catheters, which can improve delivery of the catheter to, including time needed to reach, the target site in a patient.

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4

Balloon Catheter Hypotube Strength Comparison

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Example 5

The strength of the hypotube of the balloon catheter in accordance with the disclosed subject matter prepared as described above was tested and compared to known balloon catheters including the Synergy II® (commercially available from Boston Scientific), Promus Premier® (commercially available from Boston Scientific), and Resolute Integrity® (commercially available from Medtronic). The strength of the hypotube was tested by applying a bending force perpendicular to the main axis of a straight portion of the hypotube until it is bent by 90°. The higher the force it takes to bend the hypotube a certain angle (bending modulus), the higher its bending resistance and thus its strength. The results of the testing are shown in FIG. 19, which plots the bending resistance (in-lb) against the angle. A higher bending resistance represents a stronger hypotube. As depicted in FIG. 19, catheters in accordance with the disclosed subject matter having a hypotube with the dimensions and the stepped skive provided herein unexpectedly provide improved strength as compared to commercially available catheters. For example, the catheter in accordance with the disclosed subject matter was up 60% stronger than commercially available catheters, which can provide improved push transmission, a reduction in the tendency to kink, and smoother force transfer and tactile feedback.

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5

Comparative Analysis of Newer Generation DES Platforms

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For this analysis, we stratified newer generation DES with at least 1000 implants into BP-and PP-DES groups. The BP-DES group included the Synergy (Boston Scientific Corporation, Marlborough, MA, USA), Orsiro (Biotronik AG, Bu ¨lach, Switzerland), and Ultimaster (Terumo Corporation, Tokyo, Japan) stent platforms. Characteristics of different BP-DES used in this study are shown in the Supplementary material online, Table S1. The PP-DES group included: Xience Prime and Xience Xpedition (Abbott Vascular, Santa Clara, CA, USA); Promus Element, Promus Element Plus and Promus Premier (Boston Scientific, Natick, MA, USA); Resolute Integrity and Resolute Onyx (Medtronic Inc., Minneapolis, MN, USA).
To more broadly reflect the current clinical practice, the thick and non-contemporary Biomatrix stent (Biosensors Interventional Technologies Pte Ltd, Singapore) was excluded from the analysis. To avoid double counting of patients, only the first registered PCI procedure during the inclusion period was selected for the analysis. Also, patients implanted with a mixture of different stent types at the index procedure were excluded.
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6

Balloon Catheter Hypotube Strength Comparison

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Example 5

The strength of the hypotube of the balloon catheter in accordance with the disclosed subject matter prepared as described above was tested and compared to known balloon catheters including the Synergy II® (commercially available from Boston Scientific), Promus Premier® (commercially available from Boston Scientific), and Resolute Integrity® (commercially available from Medtronic). The strength of the hypotube was tested by applying a bending force perpendicular to the main axis of a straight portion of the hypotube until it is bent by 90°. The higher the force it takes to bend the hypotube a certain angle (bending modulus), the higher its bending resistance and thus its strength. The results of the testing are shown in FIG. 19, which plots the bending resistance (in-lb) against the angle. A higher bending resistance represents a stronger hypotube. As depicted in FIG. 19, catheters in accordance with the disclosed subject matter having a hypotube with the dimensions and the stepped skive provided herein unexpectedly provide improved strength as compared to commercially available catheters. For example, the catheter in accordance with the disclosed subject matter was up 60% stronger than commercially available catheters, which can provide improved push transmission, a reduction in the tendency to kink, and smoother force transfer and tactile feedback.

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7

Retrospective Study of Second-Generation DES in CAD

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This retrospective, single-center, observational study was based on 4,700 consecutive patients with coronary artery disease undergoing PCI with DES between January 2010 and December 2013, of whom 3,580 patients underwent PCI for the first time during the study period. After excluding 127 patients who underwent PCI with a bare-metal stent (n=17) or first-generation DES (n=110), we analyzed 3,453 patients exclusively treated with second-generation DES (Figure 1). The second-generation DES included Endeavor (Medtronic Vascular, Santa Rosa, CA, USA), XIENCE V (Abbott Vascular, Santa Clara, CA, USA), NOBORI (Terumo, Tokyo, Japan), PROMUS (Boston Scientific, Natick, MA, USA), and Resolute Integrity (Medtronic Vascular) stents. The study was conducted in accordance with the provision of the Declaration of Helsinki and the guidelines for epidemiological studies issued by the Ministry of Health, Labour and Welfare of Japan. All patients provided informed consent for the procedure and subsequent data collection, and patients included in this study provided consent for their data to be published.
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8

Primary PCI for Acute Myocardial Infarction

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Within 12 h after the first symptoms, primary PCI was performed. There are two types of stents: bare-metal and drug-eluting stents (Resolute Integrity (Medtronic, USA), Integrity (Boston Scientific, USA, respectively)). Coronary angiography was undertaken on an Integris Allura digital X-ray system (Philips Healthcare, Best, The Netherlands). Several projections of coronary arteries have been recorded during coronary angiography. Ultravist-370 (Bayer Pharma GmbH, Germany) was used to increase contrast. All patients received standard treatment [12] .
Using serial electrocardiography in 12 leads obtained before and 60-90 minutes after primary PCI evaluation of ST-segment dynamics was performed [13] .
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9

Comparative Stent Performance Analysis

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For additional comparison beyond LEADERS we used two previous randomized clinical studies and two clinical registries conducted with the BES to help put the outcomes of this new registry into appropriate perspective. The SORT-OUT VI study compared the BES with the Zotarolimus-eluting stent (Resolute Integrity™, Medtronic, Minneapolis, MN, USA) in a randomized fashion [15] (link), and the SORT-OUT VIII trial compared the BES with the everolimus-eluting stent [16] (Synergy™, Boston Scientific, Malborough, MA, USA). The e-BioMatrix Registry included 5,472 patients in Europe and Middle East and was published in 2015 [17] . The e-Biomatrix French Registry recruited 2,365 patients and was published in 2017 [18] .
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10

Outcomes of Second-Generation DES in Patients

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We combined data from 7 prospective, randomized trials enrolling patients with second‐generation DES that were maintained at the Cardiovascular Research Foundation (New York, NY) in which treated lesion ACC/AHA class was determined at an angiographic core laboratory. The data that support the findings of this study are available from the corresponding author upon reasonable request. Clinical follow‐up was performed for up to 5 years. The designs of the trials have been previously described and are summarized in Supplemental Table S1.10, 11, 12, 13, 14, 15, 16 As we sought to study contemporary DES outcomes, only patients in which a single lesion was treated with a contemporary second‐generation DES (Xience V or Xience Prime, Abbott Vascular, Santa Clara, CA; Promus, Boston Scientific, Marlborough, MA; Nobori, Terumo, Tokyo, Japan; and Resolute Integrity, Medtronic, Santa Rosa, CA) were included in the analysis. Patients were censored at time of first event or at last follow‐up time, whichever occurred first. Each trial was approved by the institutional review board or ethics committee at the respective participating centers, and all patients signed written informed consent before randomization.
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