A New Generation of Fully Bioresorbable Coronary Scaffold Has Arrived

Supported by the Hong Kong and Macao Approved Drugs and Medical Devices Access Scheme, the Freesolve™ Sirolimus-Eluting Coronary Resorbable Magnesium Alloy Scaffold (RMS) System has been successfully introduced at Clifford Hospital.

On June 1, the cardiovascular team led by Dr. Hong Changjiang, chief physician successfully implanted the scaffold system in a patient with coronary atherosclerotic heart disease (coronary artery disease, CAD). This marks a new innovative treatment option for patients with complex coronary lesions.

Resorbable Scaffold: An Innovative Advancement in Coronary Artery Disease Treatment

Coronary artery disease (CAD) is one of the most prevalent cardiovascular diseases and remains one of the leading causes of mortality worldwide. In recent years, the aging population has contributed to a continuous increase in the number of patients affected by coronary artery disease.

Coronary stent implantation is one of the most commonly used treatment for CAD. By providing mechanical support to expand narrowed coronary arteries, implanted scaffolds restore vessel patency and improve myocardial blood perfusion.However, conventional metallic drug-eluting stents (DES) remain permanently implanted within the coronary arteries after deployment, resulting in a lifelong foreign material presence inside the vessel.

To address concerns regarding permanent implants within the heart, bioresorbable scaffold technology offers a new-generation therapeutic approach. As an advanced technology in interventional cardiology, the Freesolve™ Sirolimus-Eluting Coronary Resorbable Magnesium Alloy Scaffold System differs fundamentally from conventional stents due to its temporary support capability and bioresorption characteristics. The scaffold provides effective radial support force during the early stage of treatment to keep the vessel open. After sufficient vascular repair and endothelialization, the scaffold is safely absorbed by the body, eliminating the need for permanent implantation.

With the support of the “Hong Kong and Macao Approved Drugs and Medical Devices Access” Scheme, Clifford Hospital successfully introduced this innovative medical device and rapidly integrated it into clinical practice.

Precision Intervention: Successful Implantation of an Innovative Vascular Scaffold

The patient undergoing the procedure was a 57-year-old male, who has suffered from CAD for many years, accompanied by essential hypertension, hyperlipidemia, and hyperuricemia. Coronary angiography revealed significant stenotic lesions in two of his major coronary vessels: the left anterior descending (LAD) artery and the left circumflex (LCX) artery. The stenosis severity was approximately 70%–80% in the LAD and approximately 80% in the LCX. More importantly, intravascular ultrasound (IVUS) examination demonstrated that the minimal lumen area (MLA) at the most severe lesion site was only 2.64 mm², roughly the size of a pinhole. Calcified plaques were also identified within the vessel wall. These complex coronary lesions meant Mr. Hong required urgent implantation of a coronary stent.

IVUS-Guided Precision Implantation

On the day of the procedure, the medical team led by Dr. Hong Changjiang, chief physician, performed the intervention under precise guidance from IVUS. During the procedure, the medical team first performed balloon angioplasty to adequately dilate the stenotic and calcified lesion segments, to optimize vessel preparation and create favorable conditions for scaffold deployment. Subsequently, a 3.0 mm × 22 mm Freesolve resorbable magnesium alloy scaffold was accurately implanted into the mid-segment of the LAD. Post-procedural coronary angiography demonstrated complete resolution of the stenotic lesion, satisfactory restoration of coronary blood flow, optimal scaffold expansion, and favorable scaffold apposition. Mr. Hong remained clinically stable after the procedure and was safely returned to the ward.

The “Hong Kong and Macao Approved Drugs and Medical Devices Access” Scheme Facilitates Access to Advanced Medical Technologies

The successful completion of this procedure at Clifford Hospital marks a significant milestone. Leveraging the "Hong Kong and Macao Approved Drugs and Medical Devices Access Scheme”, we have further aligned with international clinical frontiers, offering patients with coronary artery disease across the Greater Bay Area a broader, more diversified therapeutic options.

Since 2023, Clifford Hospital has been successively approved to introduce multiple internationally innovative medicines and advanced medical devices under this scheme, covering conditions such as migraine, lymphoma, dry eye disease syndrome, retinal disorders, and allergic conditions. Patients requiring medical care may consult relevant clinical departments according to their individual medical conditions and treatment needs.

Looking ahead, Clifford Hospital will continue leveraging policy advantages to actively evaluate and introduce more internationally validated innovative medicines and advanced medical devices that address urgent clinical needs. By accelerating the adoption of cutting-edge medical technologies, the hospital aims to enable more patients to access international-standard diagnosis and treatment services closer to home.

Freesolve™ Sirolimus-Eluting Coronary Resorbable Magnesium Alloy Scaffold System: 

Key Medical Highlights

• Restores natural vessel function after resorption and reduces bleeding risk.
• Rapid degradation within 12 months, significantly shorter than the 3year resorption period of similar devices, lowering the risk of late stent thrombosis.
• Radial support comparable to metallic stents, with thinner struts that minimize vessel wall irritation.
• Allows vessels to regain vasomotor function, preventing vessel stiffening and reducing the probability of restenosis.
• Tantalum markers ensure clear fluoroscopic visibility, enabling precise positioning and shortening procedure time.
• Does not compromise future interventions, preserving all subsequent treatment options.

This device is indicated for:

• Young patients with CAD who have a longer life expectancy.
• Patients who have concerns or aversion to permanent metallic stents.
• Patients who are unable to adhere to long-term antiplatelet therapy