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Promus premier

Manufactured by Boston Scientific
Sourced in United States

The Promus Premier is a drug-eluting stent system designed for the treatment of coronary artery disease. It features a cobalt chromium alloy platform and a durable, biocompatible polymer coating that delivers a controlled release of the antiproliferative drug everolimus to prevent restenosis.

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11 protocols using promus premier

1

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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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

Distal Outer Member Tensile Strength

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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® 72 D 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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6

Comparison of Five Stent Platforms

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We compared five platforms: Omega (Boston Scientific), Multilink 8 (Abbott Vascular, Redwood City, California, USA), Integrity (Medtronic, Minneapolis, USA), Biomatrix Flex (Biosensors, Singapore) and Promus Premier (Boston Scientific). The former three bare metal stents were chosen as they are the identical platforms to the drug-eluting Promus and Taxus Element (Boston Scientific), Xience Prime (Abbott Vascular,) and Resolute Integrity (Medtronic) stents, respectively. The Biomatrix Flex and Promus Premier stents do not have bare metal equivalents. We chose 3.5 mm diameter stents for all platforms to avoid testing a mixture of small and large vessel platforms that exist for 3 mm diameter stents depending on the manufacturer. Stent length was greater than 18 mm in all cases. Table 1 shows the stent platform structures and characteristics for the stents used.
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7

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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8

Bioresorbable Scaffolds vs. Drug-Eluting Stents in CTO PCI

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The only BRS used in this study was Absorb. However, several second-generation DES were used: Xience Prime, Xience Xpedition, and Xience Pro X (Abbott Vascular); Promus Premier, Promus Element and Synergy (Boston Scientific, Marlborough, MA); Resolute Integrity and Resolute Onyx (Medtronic, Minneapolis, MN); Nobori and Ultimaster (Terumo, Tokyo, Japan); BioMatrix (Biosensors International, Singapore); Combo (OrbusNeich, Hong Kong); Xposition S (Stentys, Paris, France); and Cre8 (Alvimedica, Istanbul, Turkey).
BRS implantation was performed as recommended by expert consensus (aggressive lesion preparation, appropriate sizing, routine intravascular imaging guidance, and high-pressure postdilatation with noncompliant balloons with a balloon-to-artery ratio of ≈1). 10 (link) DES implantation technique was left at the operator discretion. Figures 1 and2 show examples of CTO PCI with BRS and DES, respectively.
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9

Evaluation of Stent Implantation in Patients with Stent Failure

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All interventions were performed using standard techniques. Predilation, postdilation, and use of intracoronary imaging (intravascular ultrasound (IVUS) or optical coherence tomography (OCT)) were left to the operator's discretion, as well as the decision to implant a further stent in patients with ESV-confirmed SF. ESV system utilization was mandatory after stent implantation and after postdilation (if it was performed). The following DES were implanted: Xience V or Xience Prime or Xience PRO (Abbott Vascular, Santa Clara, CA, USA), Promus Element or Promus Premier (Boston Scientific, Natick, MA, USA), Biomatrix Flex (Biosensors Europe SA, Morges, Switzerland), and Cre8 (CID and Alvimedica. S.P.A., Saluggia, Italy). After the procedure, all patients were advised to continue dual antiplatelet therapy (DAPT) with aspirin and P2Y12 inhibitor months after 2nd-generation DES implantation in patients with SF-predisposing factors. Secondary endpoints were: (1) any component of the primary endpoint; (2) definite and probable stent thrombosis (ST), and (3) target vessel revascularization (TVR). Finally, as a preliminary analysis, we compared the occurrence of the primary endpoint in patients with SF III-IV stratified according to the implantation (or not) of a further stent. All endpoints were adjudicated by an independent reviewer (R.P.), who was unaware of any data.
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10

Invasive Treatment Strategies for Acute Coronary Syndromes

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Patients with ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), or unstable angina pectoris were treated using early invasive treatment strategies.
Stent implantation was performed according to current standard techniques. The 2nd DES used included Xience V, Xience Prime, Xience Expedition (Abbott Vascular, Santa Clara, CA, USA), Promus, Promus Element, Promus Premier (Boston Scientific, Natick, MA, USA), Nobori (TERUMO, Tokyo, Japan), and Resolute Integrity (Medtronic, Minneapolis, MN, USA). Several details, including the approach site (radial versus femoral), type of guiding catheter, guide wire, and other technical issues, were left to the operator's discretion.
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