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Learn about the Infla10^® Pulse^™ investigational device clinical study, Rigicon's research mission, and our commitment to advancing prosthetic urology through rigorous scientific research.

About the Clinical Study

Learn about the Infla10^® Pulse^™ investigational device clinical study, Rigicon's research mission, and our commitment to advancing prosthetic urology through rigorous scientific research.

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About Rigicon, Inc.

Sponsor Identity

Rigicon, Inc. is a medical device manufacturer focused on the development and production of implantable urologic devices. Rigicon is the sponsor of the UNITED clinical study, which is evaluating an investigational three-piece inflatable penile prosthesis.

Regulatory Oversight

The UNITED clinical study is conducted under an FDA Investigational Device Exemption (IDE) with oversight from Institutional Review Boards (IRBs) at participating sites. These regulatory bodies ensure participant safety and ethical research practices throughout the study.

Manufacturing Portfolio (Background Information)

In addition to the investigational device being evaluated in the UNITED clinical study, Rigicon's broader portfolio includes commercially available and internationally marketed devices in the field of urology.

Examples of device categories developed by the company include:

Malleable penile prostheses
Artificial urinary sphincter systems
Testicular prostheses
Surgical instruments and accessories used during implant procedures

Information about the company's other products is provided for general background only and is not related to the investigational device or the UNITED clinical study. Participation in this study does not involve, and will not provide access to, any of the company's other products.

Participant Rights

Participation in the UNITED clinical study is voluntary. You may choose not to participate or may withdraw from the study at any time without penalty or loss of benefits to which you are otherwise entitled. Your decision will not affect your current or future medical care.

Contact Information

If you have questions about the sponsor, the clinical study, or your rights as a potential participant, please contact a participating study site or the study team through the Request Information page.

The Infla10^® Pulse^™ Series

The Infla10^® Pulse^™ is an investigational three-piece inflatable penile prosthesis being evaluated in clinical studies, including the United Clinical Study for Infla10^® Pulse^™ Dynamic Inflatable Penile Prosthesis (DIPP). The device is a self-contained, fluid-filled system designed to provide voluntary control of penile rigidity for men who may be candidates for penile prosthesis implantation.

Important Device Information

All features and configurations are investigational and currently under evaluation in clinical studies. Performance characteristics are based on bench testing and engineering specifications. No clinical performance conclusions can be drawn from bench data. Clinical outcomes may vary. The device is not commercially available and is limited by Federal law to investigational use.

About This Website

This website is an educational resource for potential participants in the United Clinical Study for Infla10^® Pulse^™ Dynamic Inflatable Penile Prosthesis (DIPP) and referring physicians. The website provides information about erectile dysfunction, treatment options, the clinical study, and the investigational device.

Website Purpose

This website is owned and maintained by Rigicon, Inc. for educational purposes. The website is not advertising and does not offer the investigational device for sale. All information provided is for educational purposes only and does not constitute medical advice. Individuals interested in learning more about the clinical study should contact a participating site or speak with their urologist.

Important Website Disclaimer

This website provides educational information only and is not medical advice
The Infla10^® Pulse^™ device is investigational and not commercially available
This website is not advertising and does not offer the device for sale
Participation in the clinical study is voluntary and not all individuals will qualify
Please consult with your healthcare provider for personalized medical guidance

Our Commitment to Study Participants

Participant safety, privacy, and well-being are our top priorities throughout the clinical study process. Rigicon is committed to conducting research in accordance with the highest ethical and regulatory standards.

Participant Safety

All clinical studies are conducted under rigorous safety protocols with oversight from Institutional Review Boards (IRBs) and the FDA. Adverse events are monitored and reported in accordance with regulatory requirements.

Privacy Protection

All information collected during the clinical study is kept strictly confidential in accordance with IRB guidelines and federal regulations (HIPAA). Personal identifying information is not shared without explicit consent. Study data is de-identified and used only for research purposes.

Informed Consent

All participants provide written informed consent after receiving comprehensive information about the study procedures, potential risks and benefits, and their rights as research participants. Participation is voluntary and participants may withdraw at any time.

Ongoing Support

Study participants receive ongoing support from the study team throughout their participation. The study team is available to answer questions, address concerns, and provide information about study procedures and follow-up requirements.

Advancing Prosthetic Urology Through Research

Clinical research is essential for advancing medical knowledge and improving treatment options for patients. Through structured clinical studies, Rigicon aims to contribute evidence-based data to the field of prosthetic urology.

Evidence-Based Approach

Rigicon's clinical studies follow structured protocols designed to collect comprehensive data on device safety and performance effectiveness. Studies utilize standardized assessment procedures, validated questionnaires, and objective outcome measures to ensure the scientific validity of results. All study data is analyzed and reported in accordance with regulatory requirements and scientific standards.

Contributing to Medical Knowledge

The data collected through clinical studies contributes to the broader scientific understanding of prosthetic urology solutions. Study findings are shared with regulatory authorities and, when appropriate, with the medical community through scientific publications and presentations. This evidence-based approach supports informed decision-making by healthcare providers and regulatory agencies.

Questions About the Study?

If you have questions about the clinical study, eligibility criteria, or what participation involves, please contact a participating site or speak with your urologist.

Contacting a site does not imply eligibility or enrollment. Eligibility is determined by the study team based on specific medical criteria.

Find Participating Sites Learn About Study Details

Medical Emergencies

Important Note: Do not send medical emergencies via this website. For medical emergencies, call 911 or seek immediate medical attention.

Disclaimer

Investigational Device. Limited by Federal (or United States) law to investigational use. The Infla10^® Pulse^™ device is investigational and is being evaluated for safety and performance effectiveness in clinical studies. Bench testing data are on file. No clinical performance conclusions can be drawn from bench data. Individual outcomes may vary. This website provides educational information only and does not constitute medical advice. This is not advertising and does not offer the device for sale. Participation in the clinical study is voluntary and eligibility is determined by the study team. Not all individuals will qualify. Please consult with your healthcare provider for personalized medical guidance.