FAQ (Ultimaster™)

Sirolimus has a higher drug titer than Everolimus and Biolimus A9.¹ Compared with competitors, Ultimaster™ (sirolimus-eluting stent) can reduce the drug dose while maintaining a sufficiently high drug titer.² Drug dose reduction leads to polymer dose reduction, minimizing inflammation caused by polymer degradation.

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With the same action mechanism, every limus-family drug originates from Sirolimus. Each limus-family drug is produced only by replacing the R radical of the macrolide. Every limus-family drug has the same mTOR and FKBP12 structures. Sirolimus has a higher drug titer than Everolimus and Biolimus A9.¹ Compared with competitors, Ultimaster™ can reduce the drug dose while maintaining a sufficiently high drug titer.²

PDLLA-PCL polymer is coated on the abluminal side of Ultimaster™. Combining PDLLA and PCL gives Ultimaster™ a strong and elastic polymer to support appropriate drug release within 3-4 months after implantation. To reduce vascular inflammation and facilitate rapid vascular repair, it is essential to eliminate long-term exposure to the drug and polymer.

For reliable drug delivery, Terumo has applied “gradient coating technology” to the drug and polymer coating. The thickest part of the coating is 15μm in thickness.

Gradient abluminal coating allows reliable drug delivery leading to minimization of polymer cracking.¹

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Gradient coating reduces the risk of polymer cracking and secures reliable drug delivery. An animal study showed that gradient abluminal coating facilitates endothelialization compared with full-surface coating.¹

Stent metal generally covers 10-20% of the target vessel surface area. The drug diffuses and reaches the area uncovered by the metal. The 28-day results of a study using the iliac artery of rabbits showed that gradient abluminal coating allows drug delivery to the non-drug-coated part of the stent and prevents neointimal hyperplasia.¹

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Patients should be maintained on clinically adequate post-procedural antiplatelet therapy (aspirin, thienopyridine or other appropriate antiplatelet agents) according to the current guidelines. (In case of need, dual antiplatelet therapy can be discontinued earlier, but not before one month.¹)

Terumo has received 1 month DAPT CE Mark approval for Ultimaster™ family DESs based on a pooled analysis regarding short DAPT. A MASTER DAPT clinical trial is ongoing which compares abbreviated and prolonged DAPTs after Ultimaster™ implantation in high bleeding risk patients.²
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1.Terumo Ultimaster™ and Ultimaster™ Tansei instruction for use
2. Press release by Terumo Corp. in Nov. 2019

• Marker length is designed to be 1.0mm.
• Ultimaster™ stent is crimped so that it is positioned at the center between two radiopaque markers.

Non-clinical testing has demonstrated that the Ultimaster™ Sirolimus Eluting Coronary Stent, overlapped configuration (max. 2 stents × max. OD4mm× 38mm = 73.6mm total length) is MR conditional.
It can be scanned safely under the following conditions:

MR Conditional for

• static magnetic field of 1.5 Tesla and 3 Tesla only, with
• spatial gradient field of 36 T/m and less
• spatial gradient field product of 99 T2/m and less
• theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR) of
< 2 W/kg at 1.5 Tesla, (related to 3.6°C temperature increase; allowable level in accordance with CEM43 concept), 73.6 x 4.0 mm, overlapped configuration
< 2 W/kg at 3 Tesla, (related to 3.6°C temperature increase; allowable level in accordance with CEM43 concept), 73.6 x 4.0 mm, overlapped configuration
for 15 minutes of continuous MR scanning.

Temperatures and SAR have been derived from computer modeling with realistic human anatomy (no cooling effects considered).
MR image quality is compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.¹

Ultimaster™ and Ultimaster™ Tansei mount the same type of stent (the drug and polymer are the same), but use delivery systems different from each other. Ultimaster™ Tansei is designed for treatment of more complex lesions.

Contraindications¹

• Patients in whom anti-platelet and/or anti-coagulant therapy is contraindicated.
• Patients with lesion(s) that prevents complete inflation of an angioplasty balloon.
• Patients with known allergy to L605 cobalt-chromium alloy.
• Patients with known allergy to nickel.
• Patients with known hypersensitivity to sirolimus or its structurally related compounds.
• Patients with known hypersensitivity to lactide polymers and caprolactone polymers.
• Patients with known hypersensitivity to contrast agent that cannot be controlled prophylactically prior to Ultimaster™ Tansei Sirolimus Eluting Coronary Stent implantation.
• Patients with extreme vessel tortuosity that may impair stent placement.

Recommendations¹

• It is strongly recommended not to implant this stent in women who are pregnant.
• Effects of sirolimus during lactation have not been evaluated. Therefore it is strongly recommended to avoid breast feeding when this stent is implanted

Ultimaster™ and Ultimaster™ Tansei are made of Cobalt Chromium L605. Terumo selected CoCr L605 to provide these devices with a thin-strut design and high flexibility for optimal crossability and conformability, and to allow them to maintain good expansion capacity while preserving a high radial force.

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