On January 30, 2024, Xianruida (06669. Peridge®, a peripheral notched balloon dilatation catheter, has obtained NMPA registration approval for the treatment of occlusive lesions of autologous or synthetic arteriovenous fistula catheters for hemodialysis. Compared with ordinary balloon dilation treatment, Peridge® can effectively enlarge the lumen while reducing excessive damage to blood vessels. The launch of this product will provide a better solution for maintaining hemodialysis access for patients with end-stage renal disease.
According to reports, the Peridge® peripheral scoring balloon adopts a tubeless design, which can reduce the outer diameter of the balloon, and the outer surface of the balloon is parallel to the nitinol wire, and the tower spring design is adopted at the end of the nitinol wire, which effectively improves the anti-detachment performance, tip tensile force and bending resistance of the nitinol wire. The tension spring assembly at the balloon and tube body junction provides a stretch margin for balloon punching/depressurization, which in turn increases the strength of the nickel-titanium wire and the double-lumen tube weld joint.
When the balloon is dilated, two metal guide wires on the surface of the scored balloon (one is a nickel-titanium wire and the other is a guide wire used in surgery) can provide an effective fixed focus point, and the local pressure focus on the target intravascular plaque is conducive to the directional opening of the plaque, and at the same time enlarge the lumen, reduce the incidence and severity of elastic retraction of plaque or hyperplastic intimal tissue and blood flow restriction dissection.
Mechanism of action of the scored balloon
From the perspective of clinical use effect, when using ordinary balloon dilation, the entire outer surface of the balloon contacts the blood vessel wall, and the hardened plaque is compressed, ruptured and deformed, and the axial disordered distribution, and the vascular intima and the intima are prone to disordered tearing and destruction, which increases the risk of arterial wall damage;
Comparison of the principle of action of ordinary balloon and scored balloon
According to data released at the 2022 academic annual meeting of the Nephrology Branch of the Chinese Medical Doctor Association, by the end of 2021, nearly 750,000 hemodialysis patients had been registered in Chinese mainland, and the average dialysis age of patients was 50.9 months. With the increasing number of hemodialysis patients and the continuous extension of dialysis age, the scientific maintenance of hemodialysis access has become increasingly urgent. At present, high-pressure balloons are used for clinical treatment, and there is a pain point of short postoperative patency time. In recent years, there have been continuous international explorations and clinical studies on the use of functional balloons (nicking, cutting) combined with drug-coated balloons (DCB) for the treatment of PTA in dialysis access. After the use of scoring balloon treatment, it can achieve excellent lumen acquisition rate, which is sufficient vascular preparation for DCB treatment, and the drug coating can penetrate into the intima of blood vessels, inhibit the proliferation of smooth muscle cells, and help achieve the effect of longer vascular patency.
Since 2022, for the treatment of autologous arteriovenous fistula stenosis in hemodialysis patients, Xianruida has successively launched two paclitaxel drug-coated balloons, and the approval of the Peridge® peripheral scoring balloon will further improve the layout of Xianruida's nephrology pipeline, continue to provide better access maintenance solutions for hemodialysis patients, and prolong the lives of patients.