CaverSTIM system is now powered by ACCEL+ IPG platform.
21 October 2020
Lausanne, Switzerland, October 21th, 2020. Comphya SA, the developer of CaverSTIM, and Cirtec Medical Corp. today announced their decision to transfer the development of CaverSTIM’s implantable pulse generator (IPG) system from Cirtec’s Solace neuromodulation platform to the ACCEL+ platform, an FDA approved and CE marked IPG system for spinal cord stimulation to treat chronic pain.
The IPG is responsible for taking the user program inputs and generating the therapy pulses. It is roughly the size of a small stack of silver dollars and contains an antenna, electronic circuitry, battery, and connectors. The stimulation pulses exit the ACCEL+ IPG through two ports in the header that accept stimulation leads. The leads deliver the pulses to the tissue via insulated conductors connected to electrodes. ACCEL+ IPG has 24 independent channels. It is wirelessly rechargeable, fully programmable, and delivers the desired stimulation parameters range for Comphya’s application, fulfilling all requirements for CaverSTIM. Beginning of October, Comphya has started the pre-clinical study using the complete CaverSTIM system.
Cirtec will continue the development of the CaverSTIM system including all necessary adaptation to the paddle leads. Cirtec will support Comphya’s regulatory submission to the regulatory authorities. “We are excited to expand our partnership with Comphya,” says Brian Highley, CEO of Cirtec Medical.
ACCEL+ System has previously been CE marked and FDA approved, facilitating the regulatory process, reducing development time, and related qualification risks. “This is a significant step forward for our Erectile Dysfunction solution. ACCEL+ platform will provide an excellent, commercial-grade technical component for CaverSTIM, and accelerate Comphya to start clinical trials in early 2021”, said Rodrigo Fraga-Silva, CEO of Comphya.
CaverSTIM is the first implantable neurostimulator to restore erectile function, focused on non-responders to oral drugs. CaverSTIM is a neurostimulator with electrodes to be implanted in the pelvic cavity, which will activate and restore the neuronal path for penile erection. The technology consists of transmitting by radiofrequency operating instructions to the implantable unit, using an external control unit. The system includes two paddle leads with 12 electrodes each (2×12) and connects to an Implanted Pulse Generator (IPG) to deliver electrical stimulation. The IPG, placed subcutaneously in the lower abdomen, is wirelessly programmed using a Clinician Programmer Application to enable the appropriate sets of electrodes and program the stimulation pulse sequence. The patient can turn stimulation on/off, adjust the amplitude, or select pre-defined stimulation pulse sequences using a Patient Remote Control. The IPG is periodically recharged using the external wireless Charger.
About Comphya SA
Comphya is a medical device company based in Lausanne, Switzerland, developing a novel implantable device to restore erectile function in patients non-responsive to oral drugs (e.g., Viagra), particularly, spinal cord injury and post-prostatectomy patients. Today, these patients resort to intrapenial injections or penile implants, which are the only available yet painful, problematic, and outdated therapies.
Comphya’s patented solution is based on neuroprosthetic principles and offers a unique and superior treatment for erectile dysfunction. The system stimulates the cavernosal nerve (pro-erectile nerve) via external wireless controllers, to restore natural penile erection. The company’s goal is to offer physiological sexual function and quality of life to large parts of the male population in great need.
About Cirtec Medical
Cirtec Medical is a vertically integrated, full-service outsource partner providing end-to-end product design, development, and manufacturing of Class II and III medical devices and components. Cirtec specializes in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, and minimally invasive systems. Cirtec Medical is headquartered in Brooklyn Park, Minnesota, and has been in operation for over 30 years with a global footprint of 8 design/manufacturing sites in the US, Germany, and Costa Rica.
Rodrigo Fraga-Silva, PhD
CEO & Co-founder