FDA approves Titan Prime Inflatable Penile Prosthesis

On June 3, 2026, the FDA approved Titan Prime, an inflatable penile prosthesis (IPP) for patients with erectile dysfunction, Coloplast reported in a company announcement.¹

“We are excited to offer Titan Prime IPP, a clinically proven solution that helps men suffering from severe erectile dysfunction take back control of their intimate lives and relationships”, said Kevin Hardage, president of Coloplast Interventional Urology, in the news release.¹ “This FDA approval advances prosthetic urology and marks an important milestone for patients seeking long-term restoration of erectile function, as well as for clinicians committed to delivering the highest standard of care.”

Titan Prime builds off the company’s initial Titan IPP by providing improved flaccid flexibility for comfort and concealability. Coloplast noted that Titan Prime includes kink resistant tubing (KRT) that is 11 times as durable to abrasion failure compared with the Titan KRT, as well as cylinders with more natural flaccid aesthetics and equal rigidity and girth. The Prime press pump also features a taller deflation button and requires 50% less force to activate compared with the Titan touch pump.²

Titan Prime is built with proprietary Bioflex, which Coloplast noted is a polymer engineered for greater strength and durability than silicone. The refined IPP is designed to emulate the appearance and performance of a natural erection, with RTEs coming in a wide range of sizes, including 0.5 cm.

Titan Prime will be available to urologists and health care systems in the US via a phased launch beginning in late 2026. Coloplast also announced that they are also pursuing regulatory approvals in other countries.

REFERENCES

1. Coloplast’s Next Generation Inflatable Penile Prosthesis Approved by the FDA – can help millions of men. News release. Coloplast A/S. June 3, 2026. Accessed June 3, 2026. https://iu.coloplast.us/wp-content/uploads/2026/06/USIU_MH_Titan-Prime-IPP_FDA-approval-press-release_English.pdf
2. Titan Prime Inflatable Penile Prosthesis. Coloplast. Accessed June 3, 2026. https://iu.coloplast.us/prosthetic-urology/products/titan-prime-ipp/