Technology

Elmedical proprietary technologies BWT for Bladder cancer and DuoThermia for Prostatitis perform non-ablative high temperature treatments (hyperthermia) based on conductive heat which is better controlled than other forms of energy and administered precisely and uniformly.

Elmedical thermal treatments are administered at exact and uniform temperatures with no "hot spots” (burns) or ineffective "cold spots” because the use of conductive heat.

BWT and DuoThermia enable the synergistic effect of hyperthermia combined with drug instillation into the bladder.

Console
Elmedical uses state of the art technology specifically designed for the most stringent treatment requirements. 
The PelvixTT^TM Console controller supports 2 off-board PT1000 sensors  and 4 on-board reference sensors to ensure maximum accuracy and safety regarding temperature.
The Elmedical circulation control ensures that whenever circulation is obstructed (for any reason) no additional fluids are pushed into the bladder, pressure does not build up in the bladder, and the system sends an error message. Safety is always maintained.

Disposable set
The disposable Catheter set comprises of: a silicone Catheter, a Heating bag, Peristaltic pump tubing, Connecting tubing, a Stopcock and a Clamp.
For bladder cancer treatment there are two BWT Catheters: 16Fr Tiemmen tip & 18Fr Nelaton tip
For DuoThermia treatment: 20Fr catheter. 
The catheters allow for non-traumatic insertion to the patient and are double packed to increase sterility while initiating a procedure.

Elmedical catheters are specifically designed to have lumens which maintain a maximum flow with minimum pressure in the bladder and in the disposable set.
A stopcock with luer-lock is used to make a safe connection of a syringe to the set for a safe drainage of urine followed by a safe loading of the MMC solution.
Shelf-life of disposable set is validated for 5 years.

Safety

Power inside the system is 110V (with 110V to 240V inputs) and "floating" by means of isolation transformer. Therefore, possibility of electrical shock is minimized.

Cross-infection between patients is avoided by not allowing body liquids to contact any part of the console and by using a unique sterile disposable set that interfaces with the console. the temperature probe, which is inserted into the catheter, senses the temperature through a dedicated thin condom which is part of the disposable catheter set, heating of circulated drug solution performed through a disposable heating bag, circulation performed by means of peristaltic pump while the peristaltic pump tubing is disposable. Therefore, disinfection of the console and its parts after every procedure is not required

For patient: No risk of burning the bladder wall

For physician and staff: Closed circulation, no leak from the catheter sets, drug removed from patient at the end of the treatment directly to the heating bag one

 

 Combination of heat and drug has synergistic effect

The term hyperthermia corresponds to non-ablative high temperature, usually in the range
of 42°C – 45°C. "Thermo-chemotherapy" - the combination of hyperthermia and chemotherapy (also called "chemohyperthermia"), is known to have synergistic effect in cancer treatment.  In the last 20 years, bladder instillations of chemotherapy combined with hyperthermia proved to have good to very good efficacy in NMIBC.

• Heat selectively damages the cancer tissue (neoplastic tissue)
• Heat increases tissue drug uptake by 3 mechanisms:
• Heat increases blood flow (more available to the tissue)
• Heat increases cell membrane permeability to the drug
• Heat accelerates drug metabolism (every 1 centigrade over 37 centigrade increase at 50%) 

Office-based procedures with best patient's tolerance:

• No pain; performed with topical anesthesia only.
• No post-procedure Catheter.
• No rectal, bladder or tissue temperature probes.
• Patient returns back to normal activities the same day

the MMC solution in the unique heat exchanger (hottest point in the circulation) exposed to maximum 47°C. 

Professors Gontero, Tizzani and Cattel from Molinette medical center in Turin Italy conducted a clinical study to test the drug stability during actual BWT procedures and found that the drug is stable. This study presented in the AUA Meeting in May 2010 in San Francisco. 

Procedure comprises of the following steps:

• Catheter set Priming. 
• The Catheter inserted through the urethra into the bladder and an anchoring balloon inflated. 
• A 50 minute continuous procedure performed. 
• After the 50 minute procedure, bladder content drained through the Catheter by gravity only (no suction by a syringe) and kept within the Catheter set while neither the patient nor personnel exposed to the toxic content. Then, the whole Catheter set is disposed off as a toxic waste.

Provides uniform and precise bladder wall temperature over the entire bladder lumen through fast closed circulation of a heated solution through the bladder with: 

NO "hot spots" (burns in the posterior bladder wall).

NO "cold spots" (ineffective heating near the bladder dome and trigone). 

The whole bladder content is replaced by the fast circulation of the drug solution in about 15 seconds. 

Advantages:

• Treatment temperature is higher but limited to a "safe zone" with no burns.
• Treatment temperature is uniform.
• Drug is more concentrated.
• Drug exposed to lower temperatures (which is better for drug stability).
• Easy to insert 16Fr flexible catheter. 
• Lower prices of Console and Catheters enable better economics. 
• Less adverse events and improved patients' tolerance.