Tenex Health

Introducing the Only Minimally Invasive Treatment That Gets to the Root of Chronic Diabetic Foot Ulcers.

Why treat and re-treat the surface of your diabetic foot ulcer (DFU) indefinitely? Or worse, risk joining the 25% of patients that require amputation?1 Now, there’s a safe, simple, and single procedure that goes under the ulcer to remove the bony prominences that can cause and worsen wounds.

The Tenex Health TX® System is a minimally invasive solution that uses advanced ultrasonic technology for the precise removal of scar tissue and the contributing factor of recurrence, the bony prominence. The entire outpatient procedure takes just minutes under local anesthesia, uses mini incisions, and doesn’t require stitches. It’s a revolutionary, single-procedure treatment option that gives you a better chance of getting back on your feet sooner — and staying there.

A Single-Procedure Solution With Multiple Advantages

Tenex Health TX® System

  • Treats the scar tissue and bony prominence below the surface of the wound
  • Single treatment
  • Does not enter or expand wound
  • Removes scar tissue while sparing healthy soft tissue
  • Skin grafts not required
  • Treats the contributing factor of recurrence, the bony prominence, for a better chance of fast and lasting healing
  • Decreases overall cost of care

Conventional Diabetic Foot Ulcer Treatments

  • Treats only the surface of the wound
  • Requires multiple office visits
  • Repeat surface cleaning and debridement may expand wound area
  • Skin grafts often required
  • Can take months or longer to heal
  • Infection rates as high as 80%2, recurrence as high as 65%3, and over 25% of patients may require amputation1
  • Ongoing treatments increase cost of care

A Unique, Definitive, and Durable Solution for the Chronic Diabetic Foot Ulcer

Freed L. Diabetes 2020. Jun; 69 (Supplement 1). Diabetic foot ulcers remain a difficult to treat condition with recurrence expected, even with effective initial treatment. The author describes an innovative new treatment with an ultrasonic probe inserted around the diabetic foot ulcer, through portals into the thickened scar tissue and osseous prominence subcutaneous to the wound crater. Ultrasonic energy from the probe is used to cut and remove the scar tissue and bone, facilitating a healing response and eliminating the aggravating factor in many cases of recurrence.

105 ulcers, MW Class 1-3, were treated with this technique from Jan 2014 – Nov 2019. All ulcers were chronic, with a duration of between 3 months and over 3 years (mean = 15 months). All ulcers had been unsuccessfully treated with multiple treatment methods. Mean ulcer size was 20mm. Mean treatment time was 4.5 minutes. The ultrasonic probe was inserted through 2-4 puncture sites around each ulcer and used to cut and aspirate the thickened scar tissue, followed by the osseous prominence, beneath the ulcer. Patient follow-up was conducted weekly until healing, and thereafter at 3-month intervals.

At a mean healing time of 3.5 weeks (7 – 42 days), 101/105 or 96% of the ulcers completely healed. 5/101 or 5% of the healed ulcers subsequently recurred in 14 – 33 months. One patient developed a bacteremia and one developed a local cellulitis. Both responded to antibiotics. The treatment was shown to be relatively inexpensive and easy to learn. In conclusion, a single treatment with an ultrasonic probe provided a high rate of complete healing, with low recurrence and a low complication rate.

View the clinical study poster presentation on the American Diabetes Association website (clicking the link will take you to the ADA site).

WHAT TO EXPECT FROM THE PROCEDURE
DAY OF PROCEDURE

The procedure is performed in an outpatient setting, such as an Ambulatory Surgery Center (ASC) or your doctor’s office. You typically remain awake while your doctor uses local anesthesia.

AFTER THE PROCEDURE

Your doctor will dress the area with sterile gauze and prescribe an antibiotic.

POST-OP RECOVERY

Your doctor will recommend you keep weight off your foot while continuing to follow standard wound care management until the ulcer heals.

WHAT PATIENTS SAY
Anita (patient was not compensated for the testimonial)
Mark (patient was not compensated for the testimonial)

Tenex Health TX® vs. Conventional Treatment

Unlike the repeat cleaning and debridement that involves numerous visits to your doctor, Tenex Health TX® gets under the surface to treat diabetic foot ulcers in one treatment.

Tenex Health TX®

treats a root cause of recurrence

Conventional treatments

only treat the surface of the wound

Clinical Experience

Evidence shows that diabetic foot ulcer procedures using the Tenex Health TX® System are precise and highly effective at removing the bony prominence that can contribute to wound recurrence. In a retrospective case study of 105 DFU patients, all who had prior advanced wound care, 96% were healed with a less than 5% recurrence rate and an average healing time of less than 3.5 weeks.4

14 days after
No recurrence >26 months5

Before treatment
Ulcer present 2 years

21 days after
No recurrence >26 months5

Before treatment
Ulcer present 4 years

3 months after
No recurrence >6 months5

Before treatment

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    Tenex Health’s minimally invasive technology eliminates chronic tendon and bone spur pain by precisely targeting and removing damaged tissue, without the need for conventional surgery.
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    References:

    1. Kim S, et al. Vasc Spec Int 2018;34:109-116.
    2. Geraghty T, LaPorta G. Expert Rev Pharmacoecon Outcomes Res 2019 Jun;19(3):279-286.
    3. Armstrong DG, et al. N Engl J Med 2017; 376:2367-2375.
    4. Freed L. Diabetes 2020 Jun;69(Supplement 1).*
    5. Data from independent case review. Tenex Health, MKT-392 REV A. Data on file.

    *Studies were the independent work of the participating physicians and were not promoted by Tenex Health, Inc. in any way. Tenex Health, Inc. does not promote use of the TX1 MicroTip or TX2 MicroTip for the treatment of hard tissue pathology or diabetic foot ulcers. The TX-Bone (TXB) MicroTip was developed, indicated, and FDA cleared for the treatment of hard tissue pathology and diabetic foot ulcers.