Previous projects

Each company has important projects determining its professional past. These are the ones we are the proudest of, milestones through which we can show the path our company has proceeded along so far.

Symphion (IoGyn Inc.)

System description

The Symphion System is a next-generation surgical system for the hysteroscopic removal of fibroids (myomas) and polyps, which unites bladeless resection (cut & coag) with intrauterine pressure regulated saline circulation. By using this system, the removal of symptomatic fibroids and polyps becomes safer and less invasive than with common surgical approaches and is aimed to preserve a woman’s ability to have children.

Our role in the project

We contributed to the development of the probe of the handheld device, the controller and the fluid management system in a mere eleven months from the first prototype to its clinical study stage. We participated in the clinical experiments conducted at Semmelweis University of Medicine. We manufactured approx. 1000 devices for testing and clinical experiments.
We helped our client partner prepare the documentation required for FDA approval submission as well as arranging further procedures required for acquiring the clearance. FDA clearance was granted in less than eighteen months following the start of the project. After acquiring FDA approval IoGyn was acquired by Boston Scientific broadening its medical device portfolio. We also took part in manufacturing the first generation of the device as well as in its production transfer to Costa Rica. The silicone seals built into the device are to this day supplied by our company.

iKnife (MediMass Ltd.)

System description

iKnife is a special surgical device that identifies biological tissues during surgery based on chemical composition by using rapid evaporative ionization mass spectrometry (REIMS). By doing this it gives real-time information whether the tissue contains cancer cells or not. This piece of information enables the operating surgeon to remove all cancer cells and also reduces the damage to nearby healthy tissues. Precise antimicrobial therapy can be initiated based on the bacteriological results obtained during surgery. iKnife also provides greater safety than conventional instruments and results in shorter and less expensive surgical procedures.

Our role in the project

The partner was in need of engineering and prototype-making support as well as manufacturing capacity to create the specific prototypes. Within two weeks into the project we created the first prototypes of iKnife. Apart from designing and manufacturing handheld devices we made 1000 iKnife blades of various types for examination and testing. MediMass Ltd was bought by Waters Corporation. We are supporting Waters presently still by designing and testing new device variants helping Waters to implement the commercial exploitation of the technology.

Minerva EAS (Minerva Inc.)

System description

Minerva EAS is a surgical system designed for controlled ablation of the endometrium, the innermost layer of the uterus. The basic operating principle is that plasma is created in the silicone membrane located at the distal tip of the device by ionization of argon gas. This plasma energy is used for ablation. The system is designed in a way to concentrate energy to the least ablated area, keeping the operation under control. It provides a safer and a less invasive method for treatment than its competitors, therefore less patients need to undergo full hysterectomy and have abnormal uterine bleeding after the treatment.

Our role in the project

We participated in the development of the controller and handheld unit, from the first prototype until the clinical study stage, and took part in the clinical studies. Our company manufactured the devices needed for initial tests and clinical studies. We supported our customer compiling the submission documentation and in further procedures that were needed for getting the FDA approval. We participated in the manufacturing the first device generation and supported the manufacturing transfer.

StabiliT (DFine Inc.)

System description

StabiliT system is used for treatment of vertebrae that are weakened and fractured as a consequence of osteoporosis. It stabilizes the injured vertebra by the injection of high-viscosity bone cement. With its articulating distal end it facilitates precise targeting of bone cement. After the operation the quality of life of the patients is improved.

Our role in the project

We took part in the design and development of the handheld devices and the controller unit from the first feasibility studies until the clinical studies, in which we were also involved. We supported our customer in compiling the submission documentation and in further procedures that were needed for getting the FDA approval. Together with a Hungarian partner company we developed the manufacturing technology that was transferred with success. One of the critical components of the system was manufactured in our cleanroom during the period following the clinical studies and the market launch. Following the FDA approval and the market launch DFine Inc. was acquired by Merit Medical.

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