ZSI 100 malleable penile implant.

01 Overview

Simple and efficient design to restore erection.

ZSI 100 is a malleable (semi-rigid) penile implant manufactured by Zephyr Surgical Implants, based in Switzerland. It is used in the surgical treatment of erectile dysfunction and mechanically supports getting and maintaining an erection. The system consists of two malleable cylinders inserted into the corpora cavernosa on either side of the penis; there is no pump, reservoir or tubing.

The cylinders are manufactured from top quality medical grade silicone and designed for long-term use. The prosthesis is permanently semi-rigid: the patient straightens the penis with one hand for intercourse and returns it to the bent position afterwards so that it stays concealed under clothing. The flexible distal part mimics the natural bending of the penis during erection, while shape memory is intended to increase comfort in the resting position.

No tissue is removed to insert the cylinders; they are placed where blood would previously flood to cause the erection. According to manufacturer documentation, the device does not affect the patient's capacity to urinate or ejaculate, nor the natural sensitivity of the penis or the glans. Lisa Health provides documented supply of the ZSI penile implant portfolio, diameter and length planning support, and operating-room preparation documentation to hospitals and urology teams. Clinical decisions and indication setting remain exclusively with the treating specialist.

02 Clinical indications

In which cases is it considered?

The ZSI 100 is positioned for cases where a durable mechanical solution for erectile dysfunction is to be achieved with a simple construction. The headings below summarise frequently assessed clinical contexts; final indication, timing and patient suitability are determined solely by the urology/andrology team.

• Erectile dysfunction refractory to conservative treatment: patients in whom PDE5 inhibitors, vacuum erection devices or intracavernosal injection therapy have failed or are not tolerated.
• Vasculogenic and neurogenic ED: cases caused by insufficient blood flow to the penis or nerve damage that do not respond to pharmacological treatment.
• Cases unsuitable for a hydraulic system: patients in whom pump and reservoir placement is considered inappropriate due to manual dexterity, cognitive status, previous pelvic surgery or scar tissue.
• Corporal fibrosis and ED with Peyronie's disease: in selected cases with advanced fibrotic change, a semi-rigid implant facilitating dilation may be considered.
• Priority on a simple procedure: when a short operating time, single-stage implantation without pelvic placement and fewer components are preferred.
• Revision surgery: may be considered as an alternative in selected revision cases after a previous hydraulic implant.

Contraindications, active urinary or systemic infection, uncontrolled diabetes, insufficient tissue perfusion and the assessment of patient compliance and expectations are addressed within the framework of the current instructions for use and clinical protocols.

03 Construction and materials

Two cylinders, no mechanical components.

The design combines malleability, sufficient rigidity and infection resistance in two cylinders. Because there is no hydraulic circuit, the failure surface of the system is markedly smaller and patient training is short.

• Malleable cylinders (2 units): inserted into the corpora cavernosa on either side of the penis; no tissue is removed during insertion.
• Material: top quality medical grade silicone selected for long-term use.
• Flexible distal part: designed to mimic the natural bending of the penis during erection and to maintain glans comfort in the flaccid position.
• Shape memory: according to the manufacturer's design the implant resumes its shape slowly after bending, which contributes to comfort in the resting position.
• Hydrophilic PVP coating: applied for better antibiotic absorption and to contribute to protection against infection.
• Adjustable body: the cylinders can be shortened by cutting at the distal and proximal ends, or lengthened with distal/proximal extenders when required.
• Aesthetics-oriented form: the optimised design targets better cosmetic results in both the flaccid and the erect position.

04 Diameter and length range

Three diameters, length adjustable from both ends.

The ZSI 100 is offered in three diameters to fit all corpora cavernosa sizes. Diameter selection follows the width obtained after corporal dilation, while length follows intraoperative corporal measurement.

Dimensions are compiled from the manufacturer catalogue; final values are confirmed with the official product documentation and current instructions for use shared with the institution.

05 Operating principle

Single-hand use in four steps.

The malleable prosthesis is permanently semi-rigid; use relies on mechanical positioning rather than hydraulic transfer and requires no external component.

• 1 — Resting position: the penis is in the bent position and stays concealed under clothing.
• 2 — Straightening: with one hand, the penis is straightened from the bent position.
• 3 — Use: the penis remains in the erect position; the shape memory of the cylinders maintains it.
• 4 — Return: with one hand, the penis is returned to the bent position.

06 Differentiating advantages

Key points for the operating room and patient quality of life.

• Simple and efficient design: the fewest possible components to restore erection; easy to adapt and easy to implant.
• Short operating time: no pelvic reservoir or scrotal pump placement is required; the procedure is completed in a single stage.
• Low mechanical failure surface: the absence of pump, valve and tubing eliminates the possibility of hydraulic failure.
• Easy size adaptation: length is adjusted in the operating room by cutting or by adding extenders; three diameters cover all corporal anatomies.
• Design addressing infection risk: a hydrophilic PVP coating is applied for better antibiotic absorption.
• Tissue-preserving placement: no tissue is removed during cylinder implantation; urination, ejaculation and penile/glans sensitivity are unaffected.
• Comfort-oriented details: the flexible distal part mimics natural bending and shape memory increases comfort at rest.
• Imaging and travel compatibility: not detected by airport security scanners and designed for safe use in medical scanners.
• Warranty: a 5-year warranty is defined by the manufacturer.

07 Comparison

Malleable or inflatable?

Implant selection in erectile dysfunction is based on patient expectations, manual dexterity, tissue quality, concomitant pathologies and cosmetic priorities. The table below compares the two ZSI options for institutional assessment; the clinical preference remains with the treating specialist.

For a neofallus created by phalloplasty, the ZSI 100 FTM version sharing the same malleable principle is used; the two products are designed for different anatomies and are not interchangeable. If a non-surgical option is under consideration, the Active3 penile vacuum device in the portfolio can be reviewed as a non-invasive alternative.

08 Technical summary

Institutional assessment table.

09 Questions & answers

Frequently asked institutional questions.