Integrated-Reservoir Inflatable Penile Prosthesis

1. What is Infla2P^™ and how does it differ from traditional three-piece inflatable penile prostheses?

Infla2P^™ is a revolutionary two-piece inflatable penile prosthesis featuring an integrated reservoir design. Unlike traditional three-piece systems that require a separate abdominal reservoir placement, Infla2P^™ combines the pump and reservoir into a single unit positioned in the scrotum. This innovative design eliminates the need for abdominal surgery, confining the procedure to a single surgical field while still delivering the reliable inflatable outcomes expected from modern penile prostheses.

2. How many pumps are required to achieve full inflation with Infla2P^™?

Internal testing demonstrates that Infla2P^™ can achieve full inflation in approximately four pumps or fewer⁹. This rapid inflation cycle provides an activation feel aligned with modern inflatable expectations, offering patients a quick and efficient response when needed.

3. What is the deflation mechanism for Infla2P^™?

Infla2P^™ features the Pulse^™ quick-deflate system, which requires a simple press of the ergonomic deflation button rather than a bending action. This intuitive, one-press deflation mechanism is consistent with the widely recognized Pulse^™ family ergonomics, ensuring a confident and comfortable user experience for patients.

4. Is Infla2P^™ pre-filled and pre-connected?

Yes, Infla2P^™ is delivered in a “box-to-body” state, meaning it is pre-filled with fluid and all components are pre-connected via kink-resistant tubing. This design significantly reduces procedural steps, minimizes tray complexity, and streamlines the surgical workflow, making it particularly well-suited for ambulatory surgery centers (ASCs) and fast-paced operating rooms.

5. What are the main surgical advantages of Infla2P^™ compared to three-piece systems?

The primary surgical advantage of Infla2P^™ is the elimination of abdominal reservoir placement, which confines the entire procedure to a single surgical field. This results in a less invasive surgery with reduced procedural complexity, potentially shorter operative times, and a streamlined closing process. Additionally, the pre-filled and pre-connected design simplifies setup and priming, making it an efficient choice for ASC workflows.

6. What cylinder sizes and lengths are available for Infla2P^™?

Infla2P^™ offers comprehensive sizing options to accommodate a wide range of patient anatomies. Anatomical fit options include 12.5 mm diameter cylinders available in 14 cm, 16 cm, and 18 cm lengths. Additional length customization is possible using ConnectSecure^™ Rear Tip Extenders.²

Note: ² Refer to the IFU and size matrix for availability by market. Device availability and indications vary by region.

7. Is Infla2P^™ suitable for all inflatable penile prosthesis candidates?

Infla2P^™ is designed for everyday inflatable candidates, not just special situations. It is indicated for men with chronic, organic erectile dysfunction who are suitable candidates for penile prosthesis implantation. It is particularly advantageous in cases where abdominal reservoir placement may be challenging or undesirable, such as in patients with prior pelvic surgery, limited abdominal space, or specific anatomical considerations.

8. How does Infla2P^™ provide both a natural flaccid state and confident rigidity?

Infla2P^™ is engineered to deliver a low-profile, discreet appearance when deflated and confident, firm rigidity when inflated. The system’s design ensures that patients experience superior comfort and confidence in all situations, with the device remaining virtually undetectable when not in use and providing reliable performance when activated.

9. Can Infla2P^™ be implanted using standard surgical techniques and tools?

Yes, Infla2P^™ is compatible with standard surgical techniques and tools. The cylinders can be placed using familiar methods such as pull-through sutures or a Furlow insertion tool. The procedure follows a standard prep and measurement protocol, making it accessible to surgeons experienced in penile prosthesis implantation.