SJ Medical
SJ Medical
Pioneering precision-engineered devices to support high-performance endovascular and transcatheter therapies globally.
Hangzhou SJ Medical Co., Ltd., founded in 2015, stands at the forefront of the design, engineering, and commercialization of class III vascular interventional medical devices. Specializing in coronary, peripheral, and structural heart technologies, we provide global medical device innovators with contract manufacturing, OEM, and ODM capabilities that compress time-to-market while guaranteeing strict clinical compliance.
With our extensive R&D capabilities, patent portfolio, and adherence to international guidelines, we engineer custom transcatheter aortic valve replacement (TAVR) solutions, delivery catheters, and accessory systems. By bridging the gap between sophisticated device architecture and high-yield, ISO-compliant manufacturing, we empower healthcare companies to launch market-leading interventional solutions.
State-of-the-art cleanrooms and micro-machining environments designed specifically for structural heart and catheter assembly.
Our facility integrates Class 10,000 (ISO Class 7) and Class 100,000 (ISO Class 8) cleanrooms, along with localized Class 100 (ISO Class 5) laminar flow workstations. These environments guarantee the particulate-free, sterile handling necessary for integrating biological tissues, Nitinol frames, and polymeric outer sheaths during TAVR and delivery system assembly.
Leveraging laser welding systems, automated balloon forming machines, high-accuracy tensile testers, and leak detectors, our manufacturing line delivers repeatable quality. Every product, from coronary microcatheters to multi-lumen heart valve delivery sheaths, is tracked via strict quality management protocols.
Optimizing supply chains, material purity, and regulatory files for cardiovascular device distributors and clinical sponsors.
Demands for next-generation self-expanding heart valves require ultra-precise laser cutting and shape-setting of Nitinol tubing. Procurement officers prioritize factories that offer fatigue testing (>200 million cycles) and precise phase-transition temperature (Af) profiling to ensure safe deployment at body temperature.
For transcatheter heart valves utilizing bovine or porcine pericardium, sourcing demands center around standardized cross-linking protocols, anti-calcification treatments, and sterile biological cleanrooms. Strict traceability from herd to final sterile package is standard.
Sponsors require delivery systems featuring high torqueability, steerability, and low profile (e.g., 14Fr or smaller) to prevent access site complications. Custom multi-lumen extrusions, braided shafts, and hydrophilic coatings must be verified under strict bio-compatibility guidelines.
From napkin sketch to high-volume commercial production, we support every stage of structural heart development.
We collaborate with your engineers to optimize the stent layout and crimp properties. Utilizing Finite Element Analysis (FEA) and simulated tracking models, we refine the device profile to ensure optimal vascular access and valve positioning.
We source raw Nitinol and biocompatible polymers (PTFE, Pebax, TPU). In our controlled facilities, we execute laser-cutting, shape-setting, and electro-polishing of Nitinol frames alongside biological leaflet preparation.
Our skilled technicians execute microscopic suturing of biological tissue leaflets to the Nitinol frame. The systems are integrated with the delivery catheter, packaged in sterile barrier systems, and prepared for sterilization.
Engineering the next generation of catheter-based cardiac interventions.
Conventional tissue valves must be stored in liquid glutaraldehyde, complicating clinical preparation and requiring rinsing before use. Our R&D team is engineering dry tissue cross-linking methods, allowing pre-mounted and pre-crimped valves to be shipped dry, simplifying the procedure in the operating room.
To minimize access-site vascular trauma, the industry is moving towards 12Fr and 10Fr delivery envelopes. We combine high-performance polymeric extrusion with thin-walled braiding and external adaptive sealing skirts to minimize paravalvular leakage (PVL).
Aligning development and volume manufacturing with international medical device standards.
Navigating global commercialization pathways requires rigorous adherence to quality systems. Hangzhou SJ Medical operates under the ISO 13485 framework, maintaining cleanroom validations, biocompatibility logs, and batch records. Our certifications and approvals include:
Our logistics and technical support extend across Europe (Finland, Italy, Spain, France, Netherlands), Asia (India, Indonesia), the Middle East, and Africa (Turkey, Egypt), ensuring smooth customs clearance and regulatory dossier support.
Answering technical, regulatory, and production questions about TAVR CDMO partnerships.
We perform critical biological tissue integration and final component mounting inside localized Class 100 (ISO Class 5) laminar flow workstations, situated within Class 10,000 (ISO Class 7) cleanrooms. This dual-barrier environment keeps bioburden, pyrogens, and particulate contamination well below international regulatory thresholds for blood-contacting cardiovascular implants.
Our Nitinol frames undergo shape-setting verification, radial force testing, and long-term fatigue cycling. We conduct testing up to 200 million cycles (simulating approximately 5 years of cardiac contractions) under physiological temperature conditions to verify structural integrity and identify potential micro-fractures.
Yes. We specialize in custom-extruded, multi-lumen braided shafts with integrated deflectable mechanisms. Our OEM/ODM service includes designing ergonomic control handles that allow clinical operators to deflect and accurately orient the valve in the native aortic root.
We process bovine and porcine pericardium, applying custom anti-calcification treatments and glutaraldehyde cross-linking protocols to improve leaflet longevity. Material selection and thickness are carefully managed to match your target performance profiles.
Extending our development and production services to advanced clinical monitors, surgical tools, and drug delivery platforms.
