Vasmed Technologies

Engineered for Optimal Outcomes:
Precision, Performance, & Safety

The Rapstrom™ Elite represents an advanced generation sirolimus-eluting coronary stent system engineered for optimal performance in the treatment of coronary artery disease. It integrates a proven L605 cobalt chromium (CoCr) alloy platform with the established anti-proliferative efficacy of sirolimus, delivered via a fully bioresorbable polymer coating.

Designed specifically for the treatment of de novo lesions (≤ 38mm) in native coronary arteries with reference vessel diameters ranging from ≥ 2.5mm to ≤ 4.0mm, Rapstrom™ Elite aims to restore and maintain coronary luminal diameter while minimizing the potential for restenosis and thrombosis.

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Platform :

Robust L605 Cobalt Chromium Platform has a radial strength of approx. 0.8 N/mm, providing superior strength over stainless steel (SS) platforms, allowing lesion scaffolding, resistance to compression, minimal elastic recoil, and enhanced radiopacity.
Drug Coating

Bioreabsorbable PLLA-PLGA based polymer combined with crystalline sirolimus minimizes long-term polymer exposure and ensures controlled release kinetics. 80% of the sirolimus dose is eluted within the initial 4 – 6 weeks.
Design & Architecture

A hybrid cell design combining open and closed cells facilitates excellent side branch access, enhances flexibility, and ensures uniform vessel support. Ultra-thin strut profile minimizes vessel wall injury during deployment and metal-to-artery surface area ratio

Key Properties of Sirolimus Drug

Sirolimus-coated crystals are mixed with a PLLA-PLGA based polymer, These polymers are proven to reduce thrombus deposition by clear reduction of TAT (Thrombin Antithrombin) and reduced platelet activation. Sirolimus-Polymer binding facilitates stronger binding of the drug, and the polymer is biodegradable within 6 months from time of implantation

Sirolimus drug is sprayed on at a dose of 1.4 Microgram/mm2 onto the abluminal side to form a base layer and a top-coat. The base layer facilitates the slow release of the drug and the top-coat provides a faster release within 5 days, of constant release. controlled drug release with 80% of drug released in the first 4-6 weeks.

Sirolimus allows dual mechanism that modulates inflammatory cell function and blocks smooth cell proliferation. The cytostatic properties of Sirolimus stops proliferation prior to GO checkpoint returning cells to GO resting phase. This prevents vessel damage and allows rapid and complete endothelization, reducing risk of thrombosis

sirolimus drug blocks smooth cell proliferation, reducing neointimal hyperplasia, which prevents vessel damage and allows for rapid and complete endothelization

100,000+

Implants Worldwide

With extensive clinical experience encompassing over 100,000 implants globally in the past decades, the Rapstrom^TM Elite Sirolimus-Eluting Coronary Stent System is supported by proven clinical data demonstrating its safety and efficacy profile in patients requiring percutaneous coronary intervention.

Technical Specifications

Balloon Type	Rapid Exchange (Rx)
Compliance Type	Semi-Compliant
Balloon Folding	Tri-Fold
Total Working Length	142
Stent Lengths (in mm)	8mm to 38 mm ( 8,13,18,23,28,33,38)
Stent Diameters (in mm)	2.50 mm to 4.00 mm (2.50,2.75,3.00,3.25,3.50,3.75 & 4.00 mm)
Distal Shaft Diameter	2.6 Fr
Proximal Shaft Diameter	1.9 Fr
Balloon Nominal Pressure (N/P)	8 atm
Balloon Rated Burst Pressure (RBP)	16 atm
Crossing Profile 2.50/2.75/3.00 3.25/ 3.50/4.00	Profile (mm) < 1.10 < 1.15
Balloon Material	Nylon
Marker Material	Platinum-Iridium
Radiopaque Markers	Dual Markers
Tip Length	4mm
Tip Entry Profile	0.019”
Distal Coating	Hydrophilic
Minimum Guiding Catheter ID	5 Fr
Maximum Guide Wire Compatibility	0.014”
Inflation Time	≤ 10 sec
Deflation Time	≤ 25 sec
Shelf Life	18 months

STENT SPECIFICATIONS
Design	Hybrid
Material	L 605 Cobalt Chromium Alloy
Strut Thickness	70 μm (0.070 mm)
Strut Width	100 μm (0.10 mm)
Radial Strength	0.8 N/mm
Maximum Expansion Profile	≤ 4 atm beyond RBP pressure 0.1 – 0.2 mm
Drug	Sirolimus
Drug Dose	1.4µg/mm² (Sirolimus per square mm of stent surface area)
Drug Elution Profile Day 1 Day 7 Total Drug on Stent	25% – 45% of label claim 50% – 80% of label claim
Polymer	PLLA-PLGA
Polymer	6 months (from time of implantation)
Mean Recoil	<5%
Mean Foreshortening	<3%

Compliance Chart

This chart illustrates the non-compliant nature of the Rapstrom Elite, showing minimal diameter growth from Nominal to Rated Burst Pressure, ensuring predictable and controlled dilation

Size	4atm	6atm	8atm	10atm	12atm	14atm	16atm	18atm	20atm
2.50mm	2.11	2.42	2.50	2.65	2.72	2.79	2.88	2.98	3.06
2.75mm	2.42	2.60	2.75	2.84	2.92	2.97	3.02	3.07	3.12
3.00mm	2.66	2.84	3.00	3.12	3.20	3.29	3.37	3.46	3.53
3.25mm	2.87	3.07	3.25	3.36	3.45	3.54	3.62	3.69	3.76
3.50mm	2.98	3.20	3.50	3.56	3.67	3.78	3.88	3.98	4.08
3.75mm	3.29	3.49	3.75	3.83	3.90	3.98	4.04	4.10	4.19
4.00mm	3.38	3.75	4.00	4.05	4.16	4.22	4.28	4.36	4.47
Nominal Pressure						Rated Burst Pressure

Warnings & Safety

The Sirolimus Drug Eluting Cobalt Chromium Coronary Stent mounted on PTCA Balloon Catheter is indicated for treatment of patients with stenosis in coronary arteries. It is indicated for improving the coronary luminal diameter in patients with symptomatic ischemic disease due to lesions of length _ 38 mm i n native coronary arteries with a reference diameter from 2.50 to 4.00 mm.

The intended purpose of Sirolimus Drug Eluting Cobalt Chromium Coronary Stent mounted on PTCA Balloon Catheter is to provide scaffolding support to a narrowed coronary artery (Stenosis) after opening it to improve blood flow and controlling neointimal hyperplasia a􀅌er vascular injury caused during the procedure at the treatment site.

1. Ensure that the inner package has not been opened or damaged as this may indicate the sterile barrier has been breached.

2. The use of product carries the risks associated with coronary artery stenting, including thrombosis, vascular complications, and/or bleeding events.

3. Patients with known hypersensitivity to L605 cobalt chromium alloy may suffer allergic reaction to this implant.

4. Patients who are unlikely to comply with recommended antiplatelet therapy should not receive this product (see information regarding an􀆟platelet therapy)

1. Patients who cannot receive an􀆟-platelet/an􀆟-coagulant therapy.

2. Patients who have lesion that prevents complete inflation of an angioplasty balloon or proper placement of stent / stent system.

3. Patients with known hypersensitivity to Sirolimus or its derivatives.

4. Patients with known hypersensitivity to Polyolefin Co-polymers

Stent implantation should only be performed by physicians who have received appropriate training.
Stent placement should be performed at hospitals where emergency coronary artery bypass graft surgery is possible.
Subsequent restenosis may require repeated dilatation of the arterial segment containing the stent.
Long-term outcomes following repeated dilatation of the stent is not well characterized.
Risks and benefits should be considered in patients with severe contrast allergies.
Do not expose the delivery system to organic solvents, such as alcohol or detergents.
When drug eluting stents are used outside the specific Indications For Use, patient outcomes may differ from the results of considered clinical trial.
Care should be taken to control the guiding catheter during stent delivery, deployment and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.
Stent thrombosis is a low-frequency event that current drug-eluting stent (DES) frequently associated with myocardial are expected and should be considered in making treatment decisions as data become available.
Compared to use within the specified Indications For Use, the use of drug-eluting stents in patients and lesions outside the labelled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, myocardial infarction or death.

Potential adverse events (in alphabetical order) which may be associated with the use of a coronary stent in native coronary arteries include but are not limited to:

Abrupt stent closure
Acute myocardial infarction
Allergic reaction to anticoagulants or antithrombotic therapy or contrast medium or stent materials including stent scaffold.
Aneurysm (Coronary)
Angina
Arrhythmias, including ventricular fibrillation (VF) and ventricular tachycardia (VT)
Arteriovenous fistula
Cardiac tamponade
Cardiogenic shock
Death
Dissection
Emboli, distal (air, issue, thrombotic, device materials or stent delivery system materials)
Heart failure
Hematoma
Hemorrhage, requiring transfusion
Hypotension/Hypertension
Infection, local and/or systemic
Myocardial Ischemia
Pain at the access site
Perforation or rupture of one or more coronary arteries
Pericardial effusion
Pseudoaneurysm, femoral
Pulmonary edema
Renal failure
Respiratory failure
Restenosis of stented segment
Shock
Stent embolization
Stent migration
Stent thrombosis/occlusion
Stroke/cerebrovascular accident/Transient ischemic Attack (TIA)
Total occlusion of coronary artery
Vessel spasm
Vessel trauma (dissection, perforation, rupture or injury, including coronary) requiring surgical repair or reintervention
Potential adverse events not captured above, that may be unique to the Sirolimus drug coating.
Abnormal liver function tests
Anemia
Artralgias
Diarrea
Hypercholesterolemia
Hypersensitivity, including anaphylactic/ anaphylactoid type reactions

Rapstrom Elite

Engineered for Optimal Outcomes: Precision, Performance, & Safety

Key Properties of Sirolimus Drug

PLLA-PLGA based biodegradable polymer

Drug Release Kinetics

Cytostatic Properties

Technical Specifications

Compliance Chart

Warnings & Safety

Indications for use

Intended purpose

Warnings

Contra-indications

General Precautions

Adverse effects

Engineered for Optimal Outcomes:
Precision, Performance, & Safety