Implantable System for Remodulin Post-Approval Study

Implantable System for Remodulin Post-Approval Study

The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.

The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.

Inclusion Criteria:

• Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
• Subject is intended to receive an eligible ISR product.
• Subject is at least 22 years of age.

Exclusion Criteria:

• Subject is pregnant.
• Subject who is expected to be inaccessible for follow-up.
• Subject with exclusion criteria required by local law.
• Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).