Simeks Tıbbi Ürünler Sanayi ve Ticaret Ltd. Şti.
Simeks Medical is a Turkish manufacturer of PTCA, PTA and PTV balloon catheters for interventional cardiology and interventional radiology. Operating from its advanced facility in Istanbul Free Trade Zone, the company manufactures ISO 13485 certified medical devices and provides OEM solutions worldwide.
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Products
PTA Balloon Catheter
The Simpass ENDO series comprises PTA balloon catheters developed to treat the full spectrum of peripheral artery disease lesions. The ENDO14, ENDO18 and ENDO35 models are compatible with 0.014", 0.018" and 0.035" guidewires respectively. Balloon diameters range from 1.5 to 12 mm and lengths from 10 to 220 mm. Hydrophilic coating and a low profile balloon geometry ease lesion crossing in below-the-knee and below-the-ankle procedures.
PTCA Balloon Catheter
The Simpass PTCA balloon catheter family covers the full range of coronary dilatation needs with three models: the semi-compliant Simpass Plus, the high pressure Simpass NC/HP and Simpass CTO for chronic total occlusions. The rapid exchange catheters have a 145 cm usable length, nylon balloons and hydrophilic coating from the distal tip to the guidewire exit port. Nominal pressure is 8 atm with a 16 atm rated burst pressure, in balloon diameters from 1.25 to 6 mm and lengths from 10 to 40 mm.
PTV Balloon Catheter
Percutaneous transluminal valvuloplasty balloon catheters for the treatment of structural heart disease. Simvalve FLEX offers a low profile and flexible design, while Simvalve FORCE provides a high pressure resistant balloon for dilating heart valve stenosis. The over-the-wire catheters have a 100 cm usable length and Nylon 12 balloons, and advanced balloon folding eases withdrawal after dilatation.
Services
Balloon Catheter Development
Ground-up development of new balloon catheter product families. Balloon forming technology, folding geometry, shaft optimisation and hydrophilic coating are engineered around the target pressure and profile figures.
OEM Medical Device Manufacturing
Medical device manufacturing under the customer brand. The strength of the Simeks OEM service comes from combining manufacturing capability with deep interventional device market experience. Clean room production, medical assembly and sterile packaging run in a single facility.
Product Design
Medical device design for interventional cardiology and radiology applications. Starting from the clinical need, catheter shaft construction, balloon geometry and coating selection are defined in CAD and matured through verification testing.