Only 3-steps to start therapy
Simple assembly and automatic transfer of the drug from the vial into the internal reservoir of the infusor
Docking station simplifies filling and charging
Products & Solutions
Gx InPuls™ Flex — Belt-worn Infusor Platform
24/7 wearable infusor flexibly adapts to a patient's therapy needs
Our Gx InPuls™ Flex is a rechargeable subcutaneous infusor for precise administration of up to 20 mL of small or large molecule drugs from a vial. The device can be worn 24/7 and has graphical interface for ease-of-use and tracking to reassure patients and support independence.
Flexibility is a key feature of the Gx InPuls™ Flex – design, delivery profiles, and display can be flexibly adapted and programmed to a specific drug. Therapy profile can be further adjusted by a health care professional (HCP) to respond to individual patient needs after evaluation of transferred data.
The two-part design of the infusor also supports sustainability with all electronics housed in a rechargeable unit with a 3-year lifespan.
An ideal infusor for chronic disease therapy
Choose Gx InPuls™ Flex for a reliable, patient-friendly device that can be quickly adapted to deliver a specific small or large molecule drug and therapy regimen.
As a combination product based on the Gx InPuls™ Flex infusor is already on the market, you can be confident that the device technology is already proven in daily use. You can also rely on our expertise in development, manufacturing, and regulatory submission.
Benefits
Personalized, continuous therapy
Flexible 24/7 therapy delivery is adjustable to a specific disease and patient profile.
Safe, simple usage
Full-color graphical user interface and audible signals guide and reassure the patient.
Eco-design concept
Sustainable two-part design with rechargeable electronics unit and two batteries enables continuous use.
Reduced risk & time-to-market
Platform concept with proven technology for fast adaptation to different drug volumes & viscosities
Full-service partnership
Extensive experience in development, manufacturing, human factors, and regulatory submission.
Improved patient independence and personalized care
The Gx InPuls™ Flex belt-worn device is designed for therapies to treat long-term conditions that may need to be adjusted to individual patient needs.
24/7 therapy facilitates ongoing treatment of conditions such as Parkinson’s disease
Wearable device with infusion set enables free movement instead of being tied to a static pump system
Data display for patients gives reassurance and transfer to health care providers supports therapy evaluation and intervention
Adjustable basal and bolus profiles allow personalized medicine configuration
Safe, simple usage with comprehensive guidance
With full graphical display, loading and charging station, safety alerts and large soft-touch keys the Gx InPuls™ Flex combines comprehensive guidance with ease of use.
Customized color graphical display in local language
3 soft-touch contextual buttons for simple operation
Customizable indicators show profile, progress, and more
- Optional RFID recognition verifies the drug details
- Audible alerts for occlusion, end of infusion, and low battery help avoid errors
- Charging unit and 2 batteries, each with a 5-day charge, support uninterrupted use
Reliable, adjustable 24-hour therapy
Our patented SensCore micro pulse pump delivers precise, controlled delivery of a therapeutic drug. Adjustable flowrates with customizable basal and bolus profiles enable adaptation to a specific drug and therapy regimen.
-Delivers very accurate dosing at low increments of 10 µl.
-Provides double protection against free flow as there is only ever one valve in the pump mechanism open and both valves are closed simultaneously when the pump is inactive
-Gradual infusion can be programmed over a range of a few hours up to several days
Sustainability & usability hand-in-hand
Useability and sustainability go hand-in-hand in our infusors. Our two-part eco-design concept has a reusable unit (RU) housing electronics and a sterile disposable unit (DU) containing the needles.
Reduce – Size, weight & number of components have been minimized
Reuse – Cost & waste is reduced as the electronic components and batteries are housed in the rechargeable unit which is not part of medical waste
Recycle – At the end of its life, the RU is recyclable
Rethink – Only the DU needs to be sterilized
Quickly adaptable for reduced time-to-market
The platform concept from Gerresheimer decreases time-to-market and development risk, thanks to:
Quick tailoring to specific drug and therapy regimen
Full-service support from Gerresheimer including manufacture and supply of primary vials
Customizable colors and options for company and product logo printing
Customizable graphic colors and data display
Large molecules delivered with ease
Delivering biologic drugs subcutaneously in a home-care setting can be challenging. Sensitive biomolecules and viscous formulations place demands on device technology. We have tested and optimized our novel SensCore micropumps which form the heart of the Gx InPuls™ platforms to confirm effective delivery of large molecule formulations at varied flow rates.
Full-service partnership
As a leading systems and solutions provider for the pharmaceutical industry, Gerresheimer can support the full device development process including supplying primary packaging.
We reduce your workload as we manage the project from initial device definition and testing, through risk management, medical device documentation, sterilization, manufacturing, and volume production at one of our worldwide facilities.
We also support the regulatory submission process to US FDA or other bodies for your combination product.
Specifications
| Drug suitability | Large and small molecule drugs |
| Primary container | 5 mL to 20 mL vial (6R to 30R) |
Fill volume | Up to 20 mL fill volume |
| Type of infusion | Subcutaneous infusion using infusion set with 30 G needle and Luer lock connection |
| Basal profile | Programmable basal profile of 5 different segments with graphical overview |
| Bolus profile | Up to 2.0 mL per bolus with up to 20 boli in 24hrs and programmable lock time between two boli |
| Infusion duration | 24/7 therapy with customizable delivery profiles |
| Battery | 2 x battery with approx. 5-day usage per battery charge & up to 3 yr lifespan |
| Display | Color graphical user interface |
| Data | History log with last 3 days on display, 90 days on file USB to download log file & update software |
| Safety & infusion tracking | Customizable visual / audible feedback including occlusion detection and alarm Expiry date, reuse protection via RFID (optional) |
Contact the expert
Andrew Moore
Global Director of Product Management & Systems Integration
