Originally Published EMDM January 2006
Market Watch
Products
Stent Manufacturer Offers Rapid Prototypes
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A turnkey contract manufacturer that has been providing stent production services to medical device OEMs since 1998 can fabricate stent prototypes in 3 to 5 days. In addition, Pulse Systems (Concord, CA, USA) has developed proprietary processes allowing it to meet and exceed customer demands for miniaturization. It routinely produces stents as small as 0.016 in. OD, with walls as thin as 0.003 in.
Stainless steel, nitinol, cobalt-chromium, and platinum are among the materials processed. The firm is equipped with tubular laser machining systems, microabrasive blasting units, and subminiature welders; passivation and electropolishing are also available. In addition to stents, the company manufactures components for minimally invasive surgical and closure devices on a contract basis.
Firm Develops Production of Gold and Platinum Stent Markers
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A company specialized in the production of precision custom components in a range of high-tech materials has recently begun offering gold and platinum markers for stent and catheter applications. The biocompatible and radiopaque components are manufactured in sizes between 0.5 and 1.5 mm diam by Rubis Précis/Micropierre (Charquemont, France).
The company employs approximately 100 qualified technicians who produce microassemblies to customer specifications in fine ceramics, ruby, sapphire, stainless steel, titanium, and other materials. In addition to markers, the firm has expertise in the design and manufacture of vitreous carbon electrodes for pacemakers, ruby-based surgical knives, sapphire bearings and pivots for spirometers, alumina and zirconia femoral heads for hip joints, and endoscope windows.
The types of materials processed by the company are increasingly sought after by medical device OEMs because of their biocompatibility, durability, electrical and thermal insulation, and corrosion and heat resistance, according to the firm, which has European Aerospace Supplier Evaluation certification.
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Turnkey Stent Design and Manufacturing Services Offered
Design, development, and production services for coronary and peripheral stents are offered by Optiray Medizintechnik GmbH (Munich, Germany). The firm also conducts analytical studies of existing stent designs that can lead to enhanced products or production processes.
The company provides a complete range of services from product concept to production including prototyping, laser cutting, annealing, electropolishing, metrology, and testing. The firm’s engineers and physicians are specialized in clinical-oriented stent solutions and make it a priority to precisely meet customer requirements. Optiray is certified to ISO 9001 and ISO 13485.
Plasma Treatment of Stents Yields Repeatable Results
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Stents and other implantable devices can be reliably and repeatably prepared for bonding, deposition, and coating by means of plasma technology. March Plasma Systems (Concord, CA, USA) designs treatment units suitable for low- to high-volume production requirements in manufacturing and cleanroom environments.
Plasma treatment can impart increased bond strength, wettability, hydrophobicity, and biocompatibility to devices. The technology enables the removal of organic and nonorganic matter that may affect the desired bond strength of a material without having an impact on its bulk properties. Plasma systems can be used to add functional groups to a surface, changing its chemical makeup to improve lubricity and adhesive properties.
Radio-frequency low-pressure plasma represents an efficient, cost-effective, and environmentally friendly method of preparing devices for treatment, according to the firm. Unlike conventional manual, chemical, or mechanical methods, plasma processing yields uniform results, and it is the only way to successfully treat chemically resistant surfaces, adds the company.
March designs and manufactures a complete line of plasma systems for all markets, and it has support centres in the United States, Europe, and the Asia/Pacific region. Staff engineers are available to assist customers in the design of plasma processes that are best suited to meet specific application requirements.
Stent-Delivery Systems Manufactured on Contract Basis
A contract manufacturer of disposable medical products offers core competence in balloon and catheter design, development, and manufacturing. Natec Medical Ltd. (Port Louis, Mauritius) provides a bulk percutaneous transluminal coronary artery catheter range with CE marking to OEMs and uses its expertise in high-technology balloon and catheter production to create customized devices and subassemblies.
The firm supplies products in semifinished and in finished form, including packaging and sterilization. The balloons range from 8 to 40 mm in length in increments of 1 mm, and in diameter from 1.5 to 4.5 mm in steps of 0.25 mm. A family of catheters for stent-delivery systems includes low-profile, rapid-exchange, and high-pushability features. Equipped with a Class 10,000 cleanroom, the company also offers in-house tooling and product design, tube forming and welding, and device assembly. It is certified to ISO 9001:2000 and ISO 13485:2003.
Lathe Integrates Microabrasive Blasting Technology
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By combining the rotational characteristics of a traditional lathe with the latest generation of microabrasive blasting, a recently introduced machine reportedly improves productivity in the removal of laser oxides and dross from stents and other devices. The advanced LA3200 lathe is suited for the precise removal of oxide layers on nitinol materials used in stents, according to Comco Inc. (Burbank, CA, USA). In fact, adds company president Neil Weightman, “we designed the advanced lathe to do this in production processes.”
Microabrasive blasting can effectively clean, cut, deburr, and texture a range of parts and surfaces. Stent manufacturers benefit from the technology’s capability to remove unwanted materials from devices without altering their intricate geometries.
All aspects of the blasting process are controlled by the machine’s software. It automatically sets all the necessary variables including pressure, travel path, and nozzle speed. The onboard computer is also network compatible, providing operators with the option of creating blasting programmes from a remote location.
Metal Tubing Supplier Adheres to Strict Quality Control
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Coronary and peripheral stents, spinal mesh, and fixation rods are among the specialty products made by an integrated manufacturer of precision tubular parts. A variety of medical-grade materials, such as titanium alloys and conventional or vacuum-melt stainless steel, are processed by Fine Tubes (Plymouth, UK), which operates a strict integrity assurance policy and follows tight process control procedures.
The quality and cleanliness of raw materials used in the fabrication of a component or device is crucial to the overall quality of the end product. Consequently, the company closely monitors inclusion levels and routinely exceeds the general assessment standards.
During manufacture, pilgering and drawing processes are used to control tolerances, the inner and outer surface finish, inclusion levels, and grain size. Inner diameters may be further refined by means of passivation, polishing, or electropolishing. Tubing surfaces can be finished down to 0.1 µm OD and 0.2 µm ID. Grain sizes Ž8 can be achieved based on ASTM E112 test methods.
Machine Automates Sheathing
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Manual sheathing of drug-eluting stents (DESs) prior to crimping is a labour-intensive process that diminishes productivity. Machine Solutions Inc. (Flagstaff, AZ, USA) has developed equipment that integrates a thin-walled film into its proprietary DES crimping technology, thus eliminating the need to manually sheath the stents.
The MSI SC775S machine features automated feeding of a protective film that replaces the sheath. The film maintains the integrity of stent polymer and drug coatings and results in the elimination of cross-contamination between crimps and stent lots.
The machine is controlled by a servomotor and PLC user interface, and it provides precise thermal crimping energy to improve stent profiles and edge protection. Additional process controls and automation options are available to maximize operator efficiency and streamline product handling.
The crimp heads can be used with any of the company’s machines that have PLC or PC controls.
Stent Maker Expands Services
A company that offers contract stent development and manufacturing, especially for cardiovascular applications, has announced an expansion of its services. After adding 7000 sq ft of production space in early 2005, Fortimedix (Nuth, Netherlands) will phase in another 30,000 sq ft over the coming years. The additional space will house the company’s new headquarters and production facilities, including cleanroom environments to satisfy increased demand for drug-eluting stents.
The company’s objective is to offer a complete technology platform involving stent development, manufacturing, and related services. Coating, drug loading, stent mounting, packaging, labelling, and product customization will be offered. These services are currently available on a pilot-production basis.
The company has developed a proprietary DES crimping technology.
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