It’s certainly going to be an extremely exciting year for innovative technology making its way into the medical device sector!
7 medical devices have been approved by the FDA for 2022 and we are here to give you the complete breakdown of each. What it is, how it works and when it is used and not used.
ECoin Peripheral Neurostimulator
What is it? – This is a system that generates electrical pulses to stimulate nerves related to bladder control. It is implanted under the skin near the ankle and remotely controlled by a health care provider.
How does it work? – Implanted under the skin of the ankle to stimulate the tibial nerve, a nerve that allows sense and movement to parts of the leg and foot. The tibial nerve also has a certain influence on the nerves that control the bladder. Nerves that control the pelvic organs, including the bladder, originate from the lower spine and are connected to the tibial nerve in the leg. It is not yet known why stimulation of the tibial nerve stimulates the nerves of the bladder.
Once implanted, the system transmits electrical pulses to the nerve in 30-minute sessions based on a fixed session. A health care provider can adjust the level of stimulation depending on the sensitivity and needs of each patient.
When is it used? – This procedure is used when patients have not been able to treat their condition through behavioral changes such as pelvic exercises, limiting fluid intake, scheduling times for urination or medication.
When should it not be used? – This device should not be used when the patient has one of the following:
- A history of surgery in the ankle implant area
- Previous unhealed damage or infection near the implant area.
- Lower leg or foot conditions such as open wounds or sores, swelling due to excessive fluid accumulation, vein or artery disease or inflammation or skin conditions.
Evoke Spinal Cord Stimulation System
What is it? – Also known as SCS, the Evoke Spinal Cord System is an implanted, rechargeable spinal cord stimulation system designed to treat long-term chronic pain. The main components of the system include an implanted signal generator connected to one or two implanted leads and a remote control that can turn the stimulator on or off to allow adjustments to therapy settings.
How does it work? – The stimulation consists of applying an electrical stimulus to the spinal cord to relieve chronic pain. It is designed to operate in either of two modes:
- In open loop stimulation mode (fixed output), the implanted signal generator receives radio signals from the remote control. These signals tell the implanted signal generator when the appropriate stimulation is required. The external remote control can be controlled by the patient or health care provider to manually adjust the stimulation level.
- In closed loop stimulation mode, the health care provider uses remote control to set a level of spinal cord activation. The system measures the activation level of the spinal cord after each electrical pulse and can automatically adjust the stimulation current to maintain consistent activation of the spinal cord.
When is it used? – As an aid in managing chronic pain in the torso or limbs, including one-sided or two-sided pain associated with failed back surgery syndrome, intractable back pain or leg pain.
When should it not be used? – This device should not be used if the patient has any of the following:
- Unable to use the SCS system
- Has not received effective pain relief during trial stimulation
- Poor SCS surgical candidates
FoundationOne CDx
What is it? – A laboratory test to find generic variations in 324 genes, as well as some specific gene rearrangements and other biomarkers, including microsatellite instability (MSI), in the genomic composition of a tumour. FoundationOne CDx is a companion diagnostic used to match a patient with a particular drug or therapy.
How does it work? – A small amount of tissue is extracted from the patient’s solid tumour. The tissue sample is sent for testing. In the laboratory, DNA is separated from tumour cells and mixed with chemical substances that find and test the DNA sequences. The sequenced DNA of the tumour uses a calculated MSI score to determine whether the MSI status is high.
When is it used? – To test the microsatellite instability of a patient’s solid tumour to determine whether the patient is eligible for a specific treatment to treat their cancer.
Eversense E3 Contagious Glucose Monitoring System
What is it? – This device provides people with diabetes with real-time blood sugar readings every 5 minutes. It consists of an implantable fluorescence sensor, a transmitter, and a mobile app to display glucose values, trends and alerts on the patient’s mobile device.
The approval of the latest version of the device enables it to be worn for up to 180 days (about 6 months) instead of the original 90 days.
How does it work? – The sensor is implanted by a doctor under the skin to monitor how much glucose is present in the fluid under the skin. A wireless transmitter outside the body takes the sensor’s information and uses Bluetooth to send the glucose reading to the Eversense app every 5 minutes on the user’s mobile device. The app is also designed to alert the user when glucose readings are too high or too low, based on the alert settings that the user has programmed. The system must be calibrated 1-2 times per day by testing a fingertip blood sample with a blood glucose metre.
When is it used? – The system is intended for people over 18 years of age with diabetes. It is intended to replace the fingerstick blood glucose measurement, which is traditionally used to make treatment decisions.
When should it not be used? – The system should not be used by people who can’t have corticosteroids dexamethasone or dexamethasone acetate.
There are some procedures that should not be carried out if the patient has an implant, including:
- For an MRI procedure that needs to be performed, the smart transmitter should be removed.
- Lithotripsy should not be performed on a patient who has an implant as the effects are not yet known.
- Diathermy should not be used on people with an inserted sensor, as the energy from the therapy can transfer through the sensor and cause tissue damage.
- Electrocautery – a heated electrode applied to living tissue to stop blood flow or destroy tissue – near an inserted sensor may damage the device.
Senza Spinal Cord Stimulation System
What is it? – A rechargeable spinal cord stimulation system to treat long-term chronic pain. The main components of the system include an implanted signal generator connected to one or two implanted leads, and a remote control that can turn the stimulator on or off to allow adjustments to therapy settings.
This supplement expands the indications of Senza SCS systems for use when programmed to a frequency of 10 kHz to help manage intractable back pain if the patient is not a candidate for back surgery and back surgery has not been performed before.
How does it work? – The implanted signal generator receives radio signals from remote control. The signals tell the signal generator when appropriate stimulation is needed for the spinal cord.
When is it used? – The SCS system, when programmed to a frequency of 10 kHz, is used as an aid to manage chronic pain in the trunk or limbs, including one-sided or two-sided pain associated with failed back surgery syndrome, intractable low back pain, leg pain, pain associated with nerve damage caused by diabetes, and refractory back pain when the patient is not a candidate for back surgery and back surgery has not been performed before.
When should it not be used? – This device should not be used if the patient has any of the following:
- Unable to use the SCS system
- Has not received effective pain relief during trial stimulation
- Poor SCS surgical candidates
Prometra Programmable Infusion Pump System
What is it? – This system is a permanently implanted battery-controlled programmable infusion pump that delivers medicine directly into the fluid-filled space around the spinal cord.
It consists of a pump, programmer, and catheter.
How does it work? – The infusion pump and the catheter are both placed under the skin during operation. The pump is usually placed on one side of the abdomen at about waist level, between the hip bone and the ribs. The catheter is threaded up the spine into the intrathecal area. After the pump is implanted, it is filled and programmed by a doctor with remote control. The pump can be programmed to provide medicines at a constant or variable rate. It can also be set to give a dose of medication that is repeated at certain times.
When is it used? – the system is used to deliver the drug Baclofen into spinal fluid in patients 12 years of age and over.
When should it not be used? – This system should not be used in patients with:
- An infection, such as a tooth abscess or a bed sore.
- A body that cannot safely accommodate the pump size and weight.
- An inability to implant the pump 2.5cm under the skin.
- Allergies to catheter materials.
- Allergies to pump materials.
- A prior intolerance to implanted devices.
- Spinal column structure that stops cerebrospinal fluid from flowing freely or will not allow intrathecal medicine delivery.
- The determination that they are not a suitable candidate is based on psychological evaluation.
- Any reason where Infumorph or Baclofen injection can’t be used.
Nucleus 24 Cochlear Implant System
What is it? – An implant that provides a person with access to sound by directly stimulating the hearing nerve. The system consists of an internal and external component. The new approval of this system extends the use of this device to people aged 5 years and over with severe to profound hearing loss in one ear and normal hearing or mild hearing loss in the other ear. It was initially approved only for people aged 9 months and over with severe to profound hearing loss in both ears.
How does it work? – The internal component is implanted in the ear by a surgeon. A microphone in the external component picks up the sounds from the environment and turns them into digitally processed signals sent to the internal component. The internal component then sends electrical pulses to the cochlea in the inner ear after receiving digitally processed signals from the external device. These pulses travel along the auditory nerve to the brain, where they are interpreted as sounds.
When is it used? – The device is intended for use to help provide a sense of sound for people over 5 years old with SSD/UHL.
When should it not be used? – This device should not be used by people with:
- No cochlear development or no cochlear nerve
- Active middle ear infections
- A ruptured eardrum with active middle ear disease
- Profound sensorineural hearing loss for more than 10 years
So, there you have it. The 7 medical devices coming this year. If you work in the medical devices sector and are looking for your next venture, give one of the guys at Focus On LifeScience a call today, and we will be happy to help.
