TherMatrx TMX3000

A Single In-Office Treatment

TherMatrx® Office Thermo Therapy™ is an advanced thermotherapy for benign prostatic hyperplasia (BPH), designed for in-office use. Proven safe and effective, minimally invasive and clinically efficacious, it requires only mild oral medications. *

Single in-office treatment:

• Easily integrated into your office with minimal patient prep and recovery time
• Does not require use of monitoring equipment such as EKG or crash cart
• Non-surgical treatment performed in the comfort and convenience of your office *

Exceptional Ease of Use:

• Three protocol options ranging in treatment time from 38-62 minutes
• Touch-screen monitor provides increased ease of use
• Autocalibration of temperature sensors

Proven Safe and Effective

• 5-year clinical data supports an improved quality of life with an exceptional safety profile *
• No unexpected long-term side effects or adverse events reported in clinical study
• Post-treatment side effects like bladder spasms or hematuria were generally transitory, minor and self-resolving *
• Less than 1% reported cases of erectile dysfunction *
• 47.1% improvement in American Urology Association (AUA) symptom score and 58.1% improvement in Peak Flow Rate at one year. *
• UL certified

Exceptional Patient Tolerance

• Only mild oral medications are needed for excellent patient tolerance and comfort during treatment

TherMatrx is appropriate for men with symptomatic BPH who are not satisfied with the results or side effects of their current BPH treatment choice. TherMatrx is ideal for patients who are interested in a non-surgical treatment and are concerned about treatment safety, sexual side effects, and cost of medications. ^{1, 2}

TherMatrx System Overview

The patented TMX3000™ Office Thermo Therapy™ System is a computer-controlled Thermo therapy treatment device that delivers microwave energy to the prostate for the treatment of symptoms associated with BPH.

Four Treatment Coil Lengths

The RX-200 Treatment Catheter is available in four heating lengths: 2.0 cm, 2.5 cm, 3.5 cm and 4.5 cm. The four antennae lengths specifically targets treatment heat to the prostatic urethral area between the verumontanum and bladder neck. The antenna is positioned 5 mm below the balloon to ensure precise and consistent positioning within the targeted prostatic tissue.

Procedure Overview

How is the procedure performed?

The procedure itself takes 38-62 minutes depending on which protocol you select. Almost any exam room in your office will be adequate — an operating room is not required.

Treatment Procedure

The treatment itself is fully automated by the TherMatrx console and will shut itself down when treatment is completed. There are only 5 “hands-on” steps:

• Insert the treatment catheter and rectal probe
• Inflate catheter balloon with 5 cc sterile water, connect urine drainage bag and apply light traction on the catheter by securing the bag to the patient's leg
• Place temperature sensors and connect the microwave cable
• Press START
• At 44° C and again at 50° C, you will perform a simple “sensor mapping” procedure to ensure the patient is receiving an optimal treatment. To do this, you simply move the temperature sensors along the catheter length and “lock-in” at the hottest point.

While the majority of patients are very comfortable, some patients may feel heat in the pelvic region, the urge to urinate or bladder spasms. A power reduction button is available and can be given to your patient, if needed. This allows them to decrease microwave power during treatment if they feel severe discomfort. ¹

Post Treatment

Once treatment is complete, the treatment catheter is removed and a trial void is recommended. If the patient can void and they have a low PVR, a catheter may not be needed. If a patient does need a catheter, it may be placed for 2-5 days. ¹ Some patients will experience bladder spasms, mild hematuria or dysuria. ¹ Advise patients to expect short-term worsening of symptoms. Expect symptom improvement in 6-12 weeks. ¹

Download PDF of Spec Sheet.

System Components:

The system is comprised of a mobile, stand-alone, operator control console and the single use Rx-200™ Treatment Catheter (transurethral antennae) that delivers microwave energy to the prostate.

The system computer monitors all treatment parameters and automatically adjusts the microwave energy as needed to achieve and maintain optimum thermotherapeutic temperatures for the selected duration of the treatment.

Disposables:

Treatment catheter 4 different lengths

Coil Length	Verumontanum to Bladder Neck
Coil Length	Verumontanum to Bladder Neck
2.0 cm	> 2.5 < 3.0 cm
2.5 cm	> 3.0 < 4.0 cm
3.5 cm	> 4.0 < 5.0 cm
4.5 cm	> 5.0 cm

Temperature Monitoring

The computerized closed-loop feedback control system automatically monitors and controls the heating by adjusting the microwave power level based on urethral temperatures. Two sensors are used to continuously monitor the prostatic urethral temperatures along the length of the catheter to control the heating of the prostate.

A third temperature sensor is inserted into a non-sterile, disposable, blind end, catheter that is attached along the anterior length of a rectal probe to continuously monitor rectal temperatures. The temperature sensor measures the temperature of the anterior rectal wall directly adjacent to the prostate.

The maximum allowed rectal temperature of 42.5° C cannot be manually changed. The power output is automatically discontinued after the treatment time has elapsed.

In order to provide safe and effective heating of a wide range of prostate sizes, the microwave antenna comes in four heating lengths (2.0 cm, 2.5 cm, 3.5 cm, and 4.5 cm). The four antennae lengths provide heating targeted to the measured length of the urethra (between the verumontanum and bladder neck) of the patient being treated. The Rx-200 Treatment Catheter is a sterile single-use device.

Protocol Selections

The standard therapy regimen is delivery of a single treatment at a control temperature of 50° C to 52.5° C for 30 to 40 minutes depending on which protocol you select. The TMX3000 gives you three protocol options.

Protocol	Ramp	Treatment Time	Temp
Protocol	Ramp	Treatment Time	Temp
Standard Protocol*	22	40	50° C
Shortened Protocol	8	30	50.5° C
Shortened Ramp	10	40	50° C
* default protocol

* Reported in TherMatrx clinical study

Support Services

Partnering for Success

AMS provides an array of support services to our customers. From on-site clinical training and support to reimbursement verification, we partner with you to ensure success.

• Clinical Specialist Support
  • AMS offers on-site procedural training and ongoing case support through our network of dedicated staff of medical professionals.
• Reimbursement Services
  • Our Health Care Affairs group is dedicated to supporting you and your practice through verification of patient eligibility and benefits, and working with your patient’s insurance carriers.
• Practice Enhancement and Patient Outreach
  • AMS is committed to helping you create awareness of BPH and treatment options through patient and community education.
• Technical Service
  • AMS offers 24-hour technical support through our emergency page system

* Data on file at AMS.

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