Norman Noble adds engineering design services for medical implants

Norman Noble, Inc., Highland Heights, Ohio, announced in February 2026 the addition of engineering design services to its medical-implant manufacturing portfolio. The new offering supports customers developing implantable devices that require advanced laser machining of nitinol, cobalt-chromium, titanium, and other high-performance alloys, and lets device makers partner with Norman Noble at the earliest stages of product development.

Through the engineering design service, Norman Noble’s team works with customers on drawing specifications, design for manufacturability, prototyping strategy, and process development with the goal of moving from concept to validated prototype faster than is typical with sequential outsourcing. The capability builds on the company’s existing offerings in laser machining, athermal Noble STEALTH laser processing, Noble SynchroFlash, and Noble DryEPolish surface finishing — all of which are already used across the cardiovascular, structural heart, neurovascular, and orthopedic implant markets.

By adding upfront design support, Norman Noble strengthens its position as a contract development and manufacturing organization (CDMO) for complex implantable devices. The expansion reflects increasing customer demand for integrated end-to-end partners that can carry a device from early concept through validated production, particularly for nitinol implants where design choices and manufacturing methods are tightly coupled.

Norman Noble, Inc. is a privately held precision contract manufacturer headquartered in Highland Heights, Ohio. The company specializes in laser machining and finishing of nitinol and other implant-grade alloys, and supports the development and manufacture of finished medical implants for global medical device customers.

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FDA approves JenaValve Trilogy transcatheter heart valve for aortic regurgitation

JenaValve Technology, Irvine, California, received U.S. Food and Drug Administration approval on March 23, 2026 for the Trilogy Heart Valve System for the treatment of symptomatic severe aortic regurgitation in patients deemed at high or greater risk for surgical aortic valve replacement. Trilogy is the first and only transcatheter heart valve approved in the United States for aortic regurgitation, addressing a long-standing unmet need in structural heart medicine.

The Trilogy device is a self-expanding, transcatheter aortic valve implant built on a low-profile nitinol frame with porcine pericardial tissue leaflets. The device’s locator architecture is designed to engage the native aortic leaflets to provide secure anchoring in regurgitant anatomy that lacks the calcified landing zone typically used for transcatheter valves indicated for aortic stenosis.

The approval is supported by the ALIGN-AR pivotal trial, which evaluated Trilogy in patients with symptomatic severe aortic regurgitation at prohibitive or high surgical risk. The trial demonstrated meaningful reductions in regurgitation severity at one year alongside acceptable safety endpoints, providing the first prospective evidence base for a dedicated AR transcatheter device in the United States.

JenaValve Technology develops transcatheter heart valve systems for the treatment of aortic regurgitation and aortic stenosis. The company is privately held and headquartered in Irvine, California.

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Gore gains FDA approval for first deep venous stent indicated for the IVC and iliofemoral veins

W. L. Gore & Associates, Newark, Delaware, announced on January 6, 2026 that the U.S. Food and Drug Administration has approved the GORE VIABAHN FORTEGRA Venous Stent for the treatment of deep venous disease in the inferior vena cava (IVC), iliac, and iliofemoral veins. The device is the first stent approved in the United States for the IVC and iliofemoral indication, and previously received FDA Breakthrough Device designation.

The FORTEGRA Venous Stent (formerly the GORE VIAFORT Vascular Stent) consists of an open-structure, self-expanding wire-wound nitinol frame and an expanded polytetrafluoroethylene (ePTFE) polymer lattice. The combination is designed to balance conformability to the natural venous anatomy with compression resistance throughout the entire device length, while the wound nitinol architecture supports fracture resistance under the dynamic mechanical loading characteristic of large-vein anatomy.

Approval was supported by an international pivotal trial that evaluated 89 patients with deep venous disease across the IVC, iliac, and iliofemoral veins. The device met its primary safety and effectiveness endpoints and demonstrated patency, freedom from clinically driven reintervention, and safety performance consistent with a first-line venous stent indication.

W. L. Gore & Associates is a privately held global manufacturing company founded in 1958 and headquartered in Newark, Delaware. Its medical products division supplies cardiovascular, vascular, structural heart, and surgical solutions in more than 50 countries and has served the deep venous disease space through prior peripheral and arteriovenous platforms.

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Dynalloy transfers Flexinol actuator wire technology to insulin pump leader

Dynalloy Inc., Irvine, California, announced the transfer of its Flexinol actuator wire technology, equipment, personnel, and know-how to support vertical integration at one of the world’s largest providers of insulin pump delivery products. The agreement also includes exclusivity for direct-to-human drug delivery applications.

Flexinol actuator wires are made of nickel-titanium shape memory alloy and contract when electrically heated, functioning as compact, silent, lightweight actuators ideally suited for the precise mechanisms required in miniaturized medical devices. The technology transfer enables the insulin pump manufacturer to integrate advanced SMA actuator capabilities directly into its production operations.

In response to the transfer, Dynalloy has relocated to new state-of-the-art facilities to support increased Flexinol actuator wire manufacturing and related value-added products and sub-assemblies for its broader customer base spanning automotive, consumer electronics, aerospace, and industrial automation applications.

[www.dynalloy.com](https://www.dynalloy.com)

PRIME Project Launches to Strengthen Global Nitinol Supply Chain

Five leading companies in the medical device industry have launched the PRIME project, a strategic initiative dedicated to advancing the consistency, scalability, and performance of nitinol materials. PRIME, which stands for PRoficient Ingot Material Evaluation, brings together deep technical expertise from every stage of the nitinol value chain.

The founding members are Fort Wayne Metals (ingot melting), Vascotube and Euroflex (tube drawing), and Admedes and MeKo MedTech (component manufacturing). Together, the consortium spans the complete nitinol production chain from melting through tube processing to final device assembly.

The initiative was created to strengthen supply chain stability and meet rising market demands through joint testing, real-world validation, and transparent evaluation of new ingot sources. A key goal is to prevent monopolistic dependencies and mitigate future supply risks for critical medical applications such as stents and heart valve frames.

Technical papers with testing data will be made available through the consortium’s website, and ingots, tubes, and components will be available for independent testing and production validation.

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Spray Tips: Spray drying

Spray drying, a method that rapidly dries aqueous or solvent-based solutions or slurries to particulate form by atomizing the liquid in a heated chamber, can be used to agglomerate fine powders and is an important method for the dehydration of fluid foods, such as milk, coffee, and egg powder extensively used in the pharmaceutical and chemical industries.

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