Rigicon Infla10®

What Is the Rigicon Infla10?

Rigicon Infla10 is a 3-piece inflatable penile prosthesis used for surgical treatment of erectile dysfunction.

The device was introduced commercially in 2019 and represents Rigicon's hydraulic penile prosthesis platform.

The implant is completely internal.

It consists of two inflatable cylinders placed inside the corpora cavernosa, a pump placed in the scrotum and a separate hydraulic-fluid reservoir placed within the pelvis or lower abdominal region.

These components are connected through prosthetic tubing to create a closed hydraulic circuit.

How the Infla10 Works

The prosthesis creates penile rigidity mechanically rather than restoring the natural vascular erection mechanism.

When the patient repeatedly squeezes the scrotal pump, fluid moves from the reservoir into the two cylinders.

As the cylinders fill, they increase in diameter and rigidity.

Depending on the selected cylinder model, they may also permit controlled longitudinal expansion.

After intercourse, the patient activates the deflation mechanism.

Fluid returns to the reservoir and the cylinders become softer.

This allows the penis to be positioned more comfortably beneath clothing.

Why It Is a 3-Piece Penile Implant

Infla10 is classified as a 3-piece prosthesis because it contains three functional component groups:

Two inflatable intracavernosal cylinders

One scrotal pump

One separate fluid reservoir

This distinguishes Infla10 from a 2-piece system such as AMS Ambicor, which incorporates fluid storage within the cylinder system rather than using a separate reservoir.

It also differs from malleable penile implants, which contain bendable rods without hydraulic components.

Infla10 Product Family

The Infla10 family includes different cylinder configurations intended for different anatomical and expansion requirements.

The principal configurations are:

Infla10 X — primarily designed for circumferential or girth expansion.

Infla10 AX — designed for both circumferential and longitudinal expansion.

Other narrower or specialized configurations may be available according to market and generation.

The device family should therefore be distinguished from a specific cylinder model.

For CMS taxonomy, Infla10 can serve as the parent device family, while X and AX can be recorded as individual variants.

Infla10 X

Infla10 X is the girth-expansion configuration.

During inflation, the cylinders increase in circumference and rigidity.

This model may suit patients whose treatment priority is strong hydraulic rigidity without specifically seeking a longitudinally expanding cylinder.

As with every penile prosthesis, final dimensions remain constrained by corporal anatomy.

Infla10 AX

Infla10 AX is the dual-expansion configuration.

It is designed to increase both circumference and cylinder length during inflation.

Current Rigicon materials describe AX as permitting longitudinal expansion of up to approximately 25% relative to the cylinder's original length, depending on anatomy.

This should not be interpreted as a guarantee of 25% additional external penile length after surgery.

Cylinder expansion and visible penile growth are not equivalent.

Current Pulse Generation

Rigicon's current Infla10 platform incorporates the Pulse pump.

The Pulse generation represents an evolution from earlier Infla10 pump designs.

Published 2026 clinical data comparing earlier and Pulse pump recipients found significantly higher ease-of-inflation and ease-of-deflation ratings in patients using the Pulse pump, although overall satisfaction scores were similar.

Because pump design has evolved over time, older Infla10 clinical studies should not automatically be treated as evaluations of every current component.

Pulse™ Scrotal Pump

The pump is implanted within the scrotum.

The patient locates it manually and repeatedly compresses it to move hydraulic fluid into the cylinders.

The deflation mechanism allows fluid to return to the reservoir.

This creates a patient-controlled erection without medication or external equipment.

Adequate hand strength, coordination and sensation are necessary for reliable operation.

AdaptiveReservoir™

Current Infla10 systems use Rigicon's AdaptiveReservoir.

The reservoir stores hydraulic fluid while the cylinders are deflated.

During inflation, fluid is transferred from the reservoir into the cylinders.

During deflation, fluid returns.

The reservoir is designed to accommodate implantation in suitable pelvic or abdominal spaces and incorporates a lock-out mechanism intended to reduce unintended fluid transfer.

Lock-Out Mechanism

Auto-inflation occurs when fluid moves into the cylinders without deliberate pump activation.

Modern inflatable prostheses incorporate mechanisms designed to reduce this problem.

Rigicon's reservoir includes a lock-out feature intended to help prevent unintended cylinder filling.

This should be described as a design feature intended to reduce auto-inflation rather than a guarantee that unintended hydraulic behavior can never occur.

HydroShield™ Coating

Rigicon uses a hydrophilic coating marketed as HydroShield.

The coating is designed to absorb an aqueous solution during surgical preparation.

This allows the surgical team to use an antimicrobial solution according to local protocols and surgeon preference.

HydroShield should therefore not be described as containing a permanently fixed antibiotic combination.

Its approach differs from devices using antibiotics incorporated directly into the prosthesis surface.

EasyClick™ Connectors

The Infla10 system uses connectors designed to simplify assembly of the hydraulic components.

Rigicon markets these as EasyClick connectors.

A secure hydraulic connection is important because leakage or tubing failure can compromise prosthesis function.

The connector system is intended to allow reliable component assembly without complex additional tooling.

Rear-Tip Extenders

Rear-tip extenders allow the surgeon to fine-tune the total length of the implanted cylinders.

They are positioned at the proximal end of the prosthesis.

Their purpose is to match the implant to measured corporal dimensions.

Rear-tip extenders should not be used as a cosmetic method for increasing penile length.

Correct sizing minimizes excessive tissue pressure and reduces the risk of malposition or erosion.

Implantation

Infla10 implantation follows the general principles of 3-piece inflatable penile prosthesis surgery.

The corpora cavernosa are exposed through a penoscrotal or infrapubic surgical approach.

Corporotomies are created.

The corporal bodies are measured and prepared.

Appropriately sized cylinders are inserted.

The pump is positioned inside the scrotum.

The reservoir is positioned in a suitable pelvic or abdominal location.

The components are connected and tested before surgical closure.

Penoscrotal Approach

A penoscrotal incision provides direct access to both the corpora cavernosa and the scrotum.

This can facilitate pump positioning and corporal cylinder placement.

It is one of the common approaches used for inflatable penile prosthesis implantation.

Infrapubic Approach

The infrapubic approach accesses the proximal corpora through an incision above the base of the penis.

It may provide rapid access to reservoir placement and corporal insertion.

Neither approach is universally better.

The decision depends on surgeon experience, anatomy, previous operations and prosthesis characteristics.

Infla10 vs AMS 700

Rigicon Infla10 and Boston Scientific AMS 700 are both 3-piece inflatable penile prosthesis platforms.

AMS 700 has been available for decades and therefore has extensive long-term mechanical-survival evidence.

Infla10 is substantially newer.

Early Infla10 studies have shown encouraging freedom from revision, but long-term evidence extending beyond a decade is not yet available.

The device families also differ in coatings, pumps, reservoirs, cylinder construction and expansion options.

No high-quality evidence currently establishes that Infla10 is universally superior to AMS 700.

Infla10 vs Coloplast Titan

Infla10 and Coloplast Titan both use paired cylinders, a scrotal pump and a separate reservoir.

Both use hydrophilic surface technologies that can absorb antimicrobial solutions selected during device preparation.

Titan has a much longer established clinical history.

Infla10 offers multiple modern cylinder configurations, including the AX dual-expansion model.

Current evidence does not support describing either prosthesis as universally better.

Infla10 vs AMS Ambicor

Infla10 is a 3-piece prosthesis.

AMS Ambicor is a 2-piece prosthesis.

Infla10 uses a separate reservoir placed within the pelvis or abdomen.

Ambicor stores hydraulic fluid within the cylinder system and therefore does not require a separate reservoir.

The 3-piece architecture generally permits greater differentiation between inflated rigidity and deflated softness.

Ambicor may be useful when avoiding reservoir placement is particularly desirable.

Infla10 vs Malleable Penile Implant

A malleable prosthesis consists of two permanently semi-rigid rods.

Infla10 uses hydraulic inflation and deflation.

This allows the penis to become rigid when desired and softer afterward.

The resulting concealability is generally better than with a malleable device.

The trade-off is greater mechanical complexity and the requirement to operate a scrotal pump.

Reliability

Published Infla10 evidence is encouraging but remains relatively short-term.

A multicenter study of 535 implantations performed between 2019 and 2022 reported approximately:

96.4% freedom from corrective surgery at one year

95.0% at two years

94.0% at three years

Mechanical-failure revision occurred in approximately 2.24% of patients during the reported follow-up.

Mean follow-up was approximately 24 months.

These data support good early durability but cannot establish 10- or 15-year mechanical survival.

Initial Safety Study

An earlier 319-patient analysis reported approximately 93.7% cumulative device survival at 36 months.

The study reported mechanical failure in approximately 2.5% of patients.

These results were based largely on patient information forms submitted to the manufacturer.

This limitation should be considered when comparing the data with independently maintained long-term device registries.

Single-Center Evidence

A 250-patient Turkish series reported approximately 97.6% freedom from explantation or revision during follow-up of up to 36 months.

Mechanical failure occurred in approximately 1.2%.

No infections were reported in that particular cohort.

These results are encouraging but represent a single-center experience and relatively short observation period.

Latest X and AX Clinical Outcomes

A 2026 study included 275 patients who received primary Infla10 X or AX implantation and completed 12-month follow-up.

Mean erectile-function scores improved substantially after implantation.

Patient-reported quality-of-life and prosthesis satisfaction scores were favorable.

The study found no significant difference in overall satisfaction between X and AX recipients.

Patients receiving the newer Pulse pump reported easier inflation and deflation than recipients of the earlier pump generation.

Overall complication rate was approximately 5.5%, and device infection occurred in one patient.

These results add useful contemporary evidence but still represent relatively short follow-up.

Mechanical Failure

Mechanical complications can involve the pump, tubing, cylinders, connectors, valves or reservoir.

Early Infla10 clinical reports included tubing failures around the pump junction in some patients.

Rigicon subsequently modified components of the system.

This illustrates why device-generation information matters when interpreting mechanical-failure studies.

An older Infla10 complication should not automatically be attributed to the current Pulse system without considering whether the relevant component has changed.

Infection

Deep prosthesis infection is a serious complication of every penile implant.

The HydroShield coating supports antimicrobial preparation but cannot eliminate infection risk.

Risk is also influenced by diabetes control, previous infection, revision surgery, skin preparation, surgical technique and other patient factors.

Confirmed infection can require prosthesis removal or specialist salvage surgery.

Erosion

Cylinder erosion occurs when prosthetic components compromise surrounding corporal, urethral or distal penile tissue.

Risk can increase with poor tissue quality, infection, reduced penile sensation, previous prosthesis surgery, fibrosis or inappropriate sizing.

Suspected erosion requires specialist evaluation.

Infla10 After Radical Prostatectomy

Men with persistent erectile dysfunction after radical prostatectomy may be candidates for Infla10 implantation.

The prosthesis provides hydraulic rigidity independently of cavernous nerve recovery.

Previous pelvic surgery can alter anatomy used for reservoir placement.

Alternative reservoir-positioning strategies may therefore be required.

Infla10 and Diabetes

Diabetes can cause severe vascular and neurological erectile dysfunction that no longer responds satisfactorily to oral medication or injections.

A penile prosthesis bypasses the damaged erectile mechanism and creates rigidity mechanically.

Diabetes also influences infection risk, so appropriate preoperative medical optimization remains important.

Infla10 and Peyronie's Disease

Men with Peyronie's disease and severe erectile dysfunction may be treated with an inflatable penile prosthesis.

Cylinder inflation can reduce some curvature by providing internal support.

Residual deformity can be treated with modeling, plication, incision or grafting when necessary.

Current evidence does not demonstrate that the Infla10 family is categorically superior to other modern 3-piece prostheses for Peyronie's disease.

Infla10 and Corporal Fibrosis

Fibrosis can occur after prolonged priapism, previous implant infection, prosthesis removal, Peyronie's disease or other corporal injury.

Fibrotic corpora may be difficult to dilate.

The chosen Infla10 configuration must fit safely within the available corporal diameter.

Narrower cylinder options or alternative implants may be more appropriate in severe fibrosis.

Does Infla10 Increase Penile Length?

The answer depends on the selected cylinder configuration.

Infla10 X primarily provides girth expansion.

Infla10 AX is designed for both girth and longitudinal expansion.

Even with AX, the prosthesis should not be marketed as guaranteed penile-lengthening surgery.

The tunica albuginea, fibrosis, previous surgery, corporal dimensions and safe implant sizing all limit expansion.

Does Infla10 Increase Girth?

Both X and AX configurations provide circumferential expansion during inflation.

This increases cylinder diameter and penile rigidity relative to the deflated state.

The actual visible change in penile girth varies according to anatomy and cylinder selection.

The implant should remain positioned primarily as treatment for erectile dysfunction rather than cosmetic girth enlargement.

Concealability

When deflated, hydraulic fluid leaves the main cylinder portions and returns to the reservoir.

This permits a softer resting state than a permanently semi-rigid prosthesis.

Most patients can position the penis comfortably under clothing.

Actual concealability depends on cylinder dimensions, anatomy, fibrosis and surgical outcome.

Manual Dexterity

Infla10 requires manipulation of a scrotal pump.

Patients need enough hand strength, coordination and sensation to inflate and deflate the system.

Severe arthritis, neurological impairment or major hand weakness may make operation difficult.

A malleable implant may be simpler for selected patients with significant dexterity limitations.

Regulatory Status

Infla10 is CE marked and marketed internationally.

Current Rigicon information states that the Infla10 system is not currently available for sale in the United States.

It should therefore not be labeled FDA approved in the CMS.

The FDA clearance associated with Rigicon penile implants applies to its Rigi10 malleable prosthesis rather than the Infla10 inflatable platform.

Evidence Compared With Older Implant Platforms

One of the most important considerations when evaluating Infla10 is the maturity of its evidence.

AMS 700 and Coloplast Titan have extensive published follow-up extending over many years.

Infla10 entered the market in 2019.

Its early mechanical and satisfaction data are encouraging, but long-term outcomes beyond a decade are not yet available.

A 2025 systematic review concluded that the low early mechanical-failure rates reported for Infla10 are promising but require confirmation through longer follow-up.

Who May Be a Good Candidate for Infla10?

Infla10 may be suitable for men with severe erectile dysfunction who are candidates for 3-piece inflatable penile prosthesis surgery.

It may particularly appeal to patients who want multiple cylinder-expansion options.

Infla10 X can be considered when girth expansion is prioritized.

Infla10 AX can be considered when controlled length-and-girth expansion is desired and anatomy is suitable.

Patients should have adequate manual dexterity and understand the benefits and limitations of hydraulic prosthetic surgery.

What Should Patients Weigh Before Choosing Infla10?

Infla10 combines modern hydraulic design with several cylinder configurations, hydrophilic coating technology and a contemporary pump and reservoir platform.

Its major limitation from an evidence perspective is time.

The prosthesis has not existed long enough to provide the same 10- to 20-year clinical data available for older implant families.

Patients should therefore balance its engineering features and favorable early outcomes against the shorter duration of independent clinical follow-up.