Rigicon Infla10® Pulse™ AX

What Is the Rigicon Infla10 Pulse AX?

The Rigicon Infla10 Pulse AX is a 3-piece inflatable penile prosthesis developed for men with erectile dysfunction who have selected penile implant surgery.

It belongs to Rigicon's Infla10 Pulse family of dynamic inflatable penile prostheses.

The AX designation identifies the model designed to provide both circumferential and longitudinal cylinder expansion.

The system consists of two inflatable cylinders implanted inside the corpora cavernosa, a manually operated pump positioned within the scrotum and a separate fluid reservoir positioned within the pelvis or lower abdominal region.

The entire prosthesis is implanted inside the body.

How the Infla10 Pulse AX Works

The device produces penile rigidity hydraulically rather than relying on the natural vascular erection mechanism.

When the patient repeatedly compresses the scrotal pump, sterile fluid moves from the reservoir into the paired intracavernosal cylinders.

As the cylinders fill, they become larger and more rigid.

The AX cylinders are designed to expand circumferentially while also allowing controlled longitudinal expansion.

After sexual activity, the patient activates the deflation mechanism.

Fluid returns to the reservoir, cylinder pressure falls and the penis becomes softer and easier to conceal.

What Does AX Mean?

Within the Infla10 product family, AX refers to the dual-expansion cylinder configuration.

The standard expansion-focused Infla10 X emphasizes girth expansion.

The AX version adds longitudinal expansion.

Rigicon currently states that Infla10 Pulse AX can provide up to 25% length expansion relative to the cylinder's original length, depending on the patient's anatomy.

This characteristic makes AX conceptually different from fixed-length inflatable cylinders.

However, it should not be interpreted as a guarantee that every patient will gain 25% penile length after surgery.

Length Expansion

The AX cylinder is engineered to elongate during inflation.

Manufacturer information describes longitudinal expansion of up to 25%.

Actual expansion is limited by the patient's corporal anatomy, tunica albuginea, scar tissue, fibrosis, previous surgery and safe cylinder sizing.

A patient's visible penile length after implantation is therefore not determined by the implant specification alone.

The 25% figure refers to the expansion capability of the prosthetic cylinder under appropriate conditions rather than a guaranteed postoperative increase in external penile length.

Girth Expansion

The AX model also expands circumferentially.

Rigicon's current Infla10 Pulse materials state that X and AX cylinders can achieve girth expansion up to approximately 46 mm in cylinder diameter.

As with length expansion, this is a device specification rather than a guaranteed change in a patient's final penile circumference.

Patient anatomy and surrounding tissues constrain the degree of expansion achieved clinically.

Four-Layer Cylinder Construction

Rigicon describes the current Infla10 Pulse cylinder as having a reinforced four-layer construction.

The additional cylinder architecture is intended to combine durability, rigidity and flexibility.

In the inflated state, the cylinder must produce sufficient axial strength for penetration.

When deflated, it must remain flexible enough to allow comfortable positioning and concealment.

The AX model attempts to combine these properties with controlled longitudinal expansion.

Pulse™ Pump

The current Infla10 generation incorporates Rigicon's Pulse pump.

The pump is positioned within the scrotum and allows the patient to control inflation and deflation.

Rigicon designed the pump to be easy to locate and manipulate through the scrotal skin.

Repeated pump compression moves fluid into the cylinders.

The deflation mechanism allows the cylinders to empty after intercourse.

Because the system requires manual pump operation, patients need sufficient hand strength and dexterity to use it reliably.

AdaptiveReservoir™

The Infla10 Pulse system uses Rigicon's AdaptiveReservoir.

This separate reservoir stores hydraulic fluid while the device is deflated.

Rigicon describes the reservoir as being designed to adapt to its implantation site and permit flexible filling depending on the surgical situation.

The reservoir also incorporates a lock-out mechanism intended to minimize unintended fluid transfer and involuntary inflation.

Because AX uses a separate reservoir, it is a true 3-piece inflatable penile prosthesis.

Lock-Out Valve

Unintended fluid transfer from the reservoir into penile cylinders can theoretically cause partial auto-inflation.

The Infla10 reservoir incorporates a lock-out valve designed to reduce this phenomenon.

The mechanism helps maintain separation between the reservoir and pressurized cylinders until the patient deliberately operates the pump.

It should be viewed as a design feature intended to reduce auto-inflation rather than a guarantee that unintended device behavior can never occur.

HydroShield™ Hydrophilic Coating

Infla10 components use Rigicon's HydroShield hydrophilic coating.

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

This allows the implanting team to use an antimicrobial solution according to the surgeon's chosen protocol and local practice.

The coating itself should not be described as a fixed antibiotic coating because the antimicrobial agent is not inherently predetermined by the device in the same manner as some antibiotic-impregnated systems.

EasyClick™ Connectors

Rigicon describes the system as incorporating EasyClick connectors.

These connectors allow manual component connection without requiring an additional assembly tool.

Connection design is important because a 3-piece implant contains multiple hydraulic components that must maintain an intact fluid circuit over time.

The connectors are part of the system's approach to simplifying intraoperative assembly.

ConnectSecure™ Rear Tip Extenders

Rear-tip extenders may be used when necessary to achieve appropriate corporal sizing.

Rigicon's ConnectSecure system is designed to provide a secure connection between the cylinder and rear-tip extender.

Available extenders allow the surgeon to fine-tune overall prosthetic length after corporal measurement.

Rear-tip extenders should be used according to patient anatomy and surgical requirements rather than to artificially increase penile length.

Available Cylinder Lengths

Current Rigicon ordering information lists Infla10 Pulse AX cylinders in:

12 cm

15 cm

18 cm

20 cm

22 cm

24 cm

The appropriate length is selected after intraoperative measurement of the corpora cavernosa.

Both penoscrotal and infrapubic product configurations are currently listed by Rigicon.

Penoscrotal and Infrapubic Options

Infla10 Pulse AX is available for penoscrotal and infrapubic implantation approaches.

The penoscrotal approach provides direct access to the corpora and scrotum for cylinder and pump positioning.

The infrapubic approach accesses the corpora from the proximal dorsal penile region.

Neither approach is universally superior.

Choice depends on surgeon experience, patient anatomy, previous operations and the specific operative situation.

Infla10 AX vs Infla10 X

The principal distinction is expansion behavior.

Infla10 X is primarily designed around girth expansion.

Infla10 AX provides girth expansion plus longitudinal expansion.

Patients concerned about preservation of penile dimensions may therefore be interested in the AX characteristics.

However, choosing AX should not be based on the assumption that it will produce a predetermined amount of penile enlargement.

Anatomical suitability remains essential.

Infla10 AX vs Narrow-Base Infla10

Rigicon also offers narrower cylinder configurations intended for patients whose corpora cannot safely accommodate standard-diameter cylinders.

These may be relevant in severe corporal fibrosis or restricted corporal anatomy.

AX serves a different purpose.

Its defining characteristic is dual length-and-girth expansion rather than a narrow cylinder profile.

The surgeon therefore chooses between configurations according to measured anatomy rather than simply selecting the model with the greatest expansion capability.

Infla10 AX vs AMS 700 LGX

Both Infla10 AX and Boston Scientific AMS 700 LGX are 3-piece inflatable penile prostheses designed to permit expansion in both length and girth.

They differ in cylinder construction, coatings, pumps, reservoirs, available dimensions and the maturity of their clinical evidence.

Infla10 AX is a newer prosthesis platform, while AMS 700 has decades of long-term published experience.

No strong independent evidence currently establishes that AX is universally superior to LGX.

The appropriate choice depends on anatomy, surgeon experience, product availability, patient priorities and informed discussion of the evidence base.

Infla10 AX vs Coloplast Titan

Coloplast Titan and Infla10 AX are both 3-piece inflatable systems but have different expansion characteristics.

Titan is generally characterized by substantial axial rigidity and circumferential expansion.

AX is specifically designed to provide circumferential and longitudinal expansion.

Titan has a longer-established clinical evidence base.

Infla10 has encouraging early and intermediate-term results but currently has less long-term follow-up.

This distinction is important when comparing devices objectively.

Infla10 AX and Penile Length

Patients considering AX may be particularly interested in penile length because of its longitudinal expansion capability.

The device should nevertheless not be marketed as guaranteed penile-lengthening surgery.

A prosthesis cannot safely expand beyond the biological limits of the corpora and tunica albuginea.

Pre-existing shortening caused by radical prostatectomy, Peyronie's disease, longstanding erectile dysfunction or fibrosis may also influence postoperative dimensions.

Appropriate counselling should distinguish cylinder expansion capability from guaranteed external penile growth.

Infla10 AX for Erectile Dysfunction After Prostatectomy

Persistent erectile dysfunction can occur following radical prostatectomy.

A 3-piece inflatable prosthesis can provide reliable mechanical rigidity when oral medication, injections or other treatments no longer produce satisfactory erections.

AX may be considered when a patient is anatomically suitable and values dual-expansion cylinder characteristics.

Previous prostatectomy can also influence reservoir placement, so the surgeon must consider prior pelvic anatomy when planning the operation.

Infla10 AX and Peyronie's Disease

Penile prostheses are an established option for men who have Peyronie's disease together with erectile dysfunction that warrants prosthetic treatment.

Cylinder inflation can itself correct part of the deformity.

If significant curvature remains, additional modeling, plication, incision or grafting may be necessary.

The rigidity and expansion characteristics of AX may make it an option for selected Peyronie's patients, but device-specific superiority for curvature correction has not been established.

Infla10 AX and Corporal Fibrosis

Corporal fibrosis can develop after priapism, previous prosthesis infection, penile surgery, Peyronie's disease or other cavernosal injury.

Severe fibrosis can make cylinder implantation technically difficult.

AX may be appropriate when the corpora can safely accommodate its cylinder dimensions.

When corporal diameter is severely restricted, a narrower prosthesis configuration may be more appropriate than AX.

The choice should therefore be made according to actual corporal measurements rather than the desire for greater expansion.

Reliability and Early Clinical Evidence

The Infla10 family was introduced in 2019, meaning its clinical evidence base is considerably newer than those of AMS 700 and Coloplast Titan.

One multicenter study involving 535 Infla10 implantations reported freedom from corrective surgery of approximately 94% at three years.

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

These outcomes are encouraging.

However, they represent the Infla10 family rather than AX-specific long-term mechanical survival, and mean follow-up in the study was approximately two years.

The result should therefore not be presented as equivalent to decades-long durability evidence.

More Recent Clinical Evidence

A separate single-center series of 250 Infla10 implantations reported approximately 97.6% freedom from revision or removal at 36 months.

The study included both X and AX configurations.

This provides additional encouraging evidence for the platform but again does not isolate long-term AX mechanical survival.

Longer independent follow-up remains important.

Patient Satisfaction Evidence

A later single-surgeon study evaluating 58 Infla10 recipients included both X and AX implants.

Approximately 91% of patients reported that they were satisfied and would recommend the procedure at six months.

However, the cohort was small, follow-up was relatively short and several device-related reoperations occurred.

The study therefore provides useful early patient-experience information but should not be interpreted as definitive long-term AX evidence.

Mechanical Failure

Like every inflatable penile prosthesis, Infla10 AX contains components that can eventually malfunction.

Potential problems include fluid loss, cylinder failure, pump malfunction, tubing failure, connector problems or reservoir dysfunction.

Published early Infla10 studies have reported mechanical revisions, including tubing-related failures in earlier generations.

The manufacturer subsequently modified aspects of the system, including the pump/tubing junction.

This is particularly important when interpreting older clinical studies because the contemporary Pulse generation is not mechanically identical in every detail to the earliest Infla10 devices.

Infection

Penile prosthesis infection remains a serious potential complication despite hydrophilic coating technology.

Risk is influenced by patient factors, diabetes control, revision surgery, previous infection, operative technique and perioperative antimicrobial protocols.

A hydrophilic implant surface is one component of infection prevention and should not be described as eliminating infection risk.

Deep infection can require removal or specialist salvage surgery.

Erosion and Tissue Injury

Cylinder pressure can occasionally contribute to erosion through surrounding tissues.

Potential sites include the distal corpora, glans and urethra.

Risk may increase with poor tissue quality, reduced sensation, infection, previous implant surgery, severe fibrosis or inappropriate sizing.

Because AX cylinders can expand longitudinally, correct measurement and patient-specific sizing remain especially important.

Concealability When Deflated

Rigicon designed the current Infla10 system to provide substantial softness in the deflated state.

When fluid returns to the reservoir, the cylinder becomes more flexible and the penis can be positioned naturally beneath clothing.

This is an important advantage over a permanently semi-rigid malleable prosthesis.

Actual concealability varies with anatomy, cylinder size, scar tissue and individual healing.

Does Infla10 AX Restore a Natural Erection?

No penile prosthesis restores the natural vascular erectile mechanism.

AX mechanically creates rigidity through hydraulic cylinder expansion.

Penile sensation, orgasm and sexual desire are separate functions and depend on the patient's underlying neurological and sexual health.

The prosthesis primarily treats inadequate penile rigidity.

Current Regulatory Availability

Infla10 carries CE marking and is marketed in multiple countries in Europe and other international markets.

Rigicon's current ordering information explicitly states that the Infla10 Pulse system is not available for sale within the United States.

The FDA clearance often associated with Rigicon concerns its Rigi10 malleable penile prosthesis, not Infla10.

For this reason, the Infla10 AX page should not display FDA approval.

Who May Be a Good Candidate for Infla10 AX?

Infla10 AX may be considered for men with treatment-resistant erectile dysfunction who are appropriate candidates for an inflatable penile prosthesis and whose anatomy can accommodate the device.

It may be particularly attractive to patients who value both girth and controlled longitudinal cylinder expansion.

Patients must also have sufficient manual dexterity to operate the scrotal pump.

The final decision should be based on anatomy, previous surgery, fibrosis, expectations, device availability and the implanting surgeon's experience.

What Should Patients Weigh Before Choosing Infla10 AX?

AX offers several distinctive engineering features, particularly dual expansion and a modern pump and reservoir system.

At the same time, it is a newer implant platform.

Patients comparing AX with Titan or AMS 700 should therefore consider not only cylinder characteristics but also the amount and duration of available clinical evidence.

The possibility of future revision, infection, erosion and mechanical failure applies to all hydraulic penile prostheses.

A balanced choice should prioritize long-term function and anatomical suitability rather than a single marketing specification.