RSCC The Patient Specific Tal

My Initial Posting

Introduction 

CoAxia NeuroFlo Catheter is one of the HUDs that have been used for the past 10 years in healthcare. The device was approved by FDA in the year 2005. CoAxia NeuroFlo Catheter is essential in the management of patients suffering from brain bleeding. The device has a hollow tube that is useful to drain the blood in the brain tissue as a result of bleeding. CoAxia NeuroFlo Catheter comprises a long stiff tube with one end consisting of two small balloons. The balloons are used to partially block blood circulation in the large blood vessels. The basic purpose of the device is to drain the blood that has been bled in the brain tissue due to conditions, such as stroke. 

Key Point

          CoAxia NeuroFlo Catheter is useful in the cerebral ischemia treatment through aneurismal subarachnoid hemorrhage emanating from symptomatic vasospasm. The treatment is secured by either endovascular or surgical intervention for the patients who have demonstrated the failure for maximal clinical treatment (Al-Mufti et al., 2018). If a physician has determined that the patient is suffering from brain bleeding and having symptomatic vasospasm, the appropriate device to use for the treatment is CoAxia NeuroFlo Catheter. The catheter is placed in the aorta, which is the largest blood vessel leading from the heart to the other parts of the body. The catheter is passed through the small hole in the upper part of the limb. The catheter’s balloons are inflated for about 45 minutes. This is to ensure reduction of blood circulation to the lower part of the body while increasing blood circulation to the upper part of the body including the brain (Christophe et al., 2017). However, the device is removed when the procedure has been completed.

Key Point

          The disease treated by CoAxia NeuroFlo Catheter is fundamentally associated with brain ischemia. The bleeding of the brain can be caused by various factors. The factors include high blood pressure and head trauma. Hypertension can lead to blood vessels damage in the brain that can facilitate bleeding due to bursting or leaking of the blood vessels (Chugh & Agarwal, 2019). Head trauma can be due to car accidents, falls, or any other type of head hit. Bleeding in the brain can lead to stroke. Therefore, immediate medical intervention is crucial to prevent brain damage due to blood clots that block blood flow to the brain cells. CoAxia NeuroFlo Catheter is essential to provide the best medical treatment to prevent the condition from getting worse. 

Summary

          CoAxia NeuroFlo Catheter device has met the requirements for Humanitarian Device Exemptions (HDEs) since it can effectively benefit the patients to treat cerebral ischemia. The device has also qualified through its uniqueness in that no counterfeit can be brought to the market and no other comparable device available that exists. The device has been approved by FDA to be used in patients with cerebral ischemia. CoAxia NeuroFlo Catheter manufacturers have incentives to develop the devices for the treatment of cerebral ischemia affecting small populations. The designation request for the manufacturing company for CoAxia NeuroFlo Catheter devices has been approved over a 45-day period by the FDA. 

References

Al-Mufti, F., Amuluru, K., Damodara, N., El-Ghanem, M., Nuoman, R., Kamal, N., … & Mayer, S. A. (2018). Novel management strategies for medically-refractory vasospasm following aneurysmal subarachnoid hemorrhage. Journal of the neurological sciences, 390, 44-51. https://doi.org/10.1016/j.jns.2018.02.039 (Links to an external site.)

Chugh, C., & Agarwal, H. (2019). Cerebral vasospasm and delayed cerebral ischemia: Review of literature and the management approach. Neurology India, 67(1), 185. DOI: 10.4103/0028-3886.253627

Christophe, B. R., Mehta, S. H., Garton, A. L., Sisti, J., & Connolly Jr, E. S. (2017). Current and future perspectives on the treatment of cerebral ischemia. Expert opinion on pharmacotherapy, 18(6), 573-580. https://doi.org/10.1080/14656566.2017.1309022

NEED REPONSES TO THE FOLLOWING

#1 Julie Question Response Needed

Introduction 

A Humanitarian Use Device (HUD) is a medical device intended to treat or help with a disease or medical issue that impacts less than 8,000 individuals in the United States Annually (CDRH, 2019). These devices can approved through a process called Humanitarian Device Exemption (CDRH, 2019). HUDs that are approved under a Humanitarian Device Exemption are except from the effectiveness qualifications of other devices (CDRH, 2019). Instead, these devices must prove the risks of not having the device available to those suffering from the malady or illness is greater than the risks associated with the device (CDRH, 2019). In addition, HUDs can not be sold for profit except under certain conditions (CDRH, 2019). The Patient Specific Talus Spacer was approved as a HUD via a Humanitarian Device Exemption (Paragon, 2021). This device is manufactured as an implant that is supposed to replace a patients talus bone in the ankle (Paragon, 2021). This device is made up of a cobalt chromium alloy (CDRH, 2021). 

Key Points 

The Patient Specific Talus Spacer is used to treat patients with Avascular Necrosis in the ankle (CDRH, 2021). In order to utilize this device individuals must have a CT scan that demonstrates the needed landmarks to create individually manufacture the device (Paragon, 2021). Avascular Necrosis is a disease that cuts off blood supply to the bone either permanently or temporarily (Joseph, 2021). This causes the bone to degrade and can cause tissue death that leads to the bones eventual collapse (Joseph, 2021). This can happen to any bone at any time, but is more common at the end of the long bone and has many potential causes (Joseph, 2021). The Patient Specific Talus Spacer is to help minimize chronic pain in the ankle due to Avascular Necrosis, aid in movement of the foot attached to the ankle, and help to prevent amputation and fusion long term (CDRH, 2021). 

This device meets the requirements for a Humanitarian Device Exemption as this disease impacts less than 8,000 individuals in the US per year in the ankle (CDRH, 2021). This disease commonly leads to severe and lasting pain for individuals and can cause joint collapse leading to amputation of the foot or joint fusion (CDRH, 2021). This type of fusion does not leave room for reconstruction and can eventually lead to the patient being unable to walk in a way that is unassisted (CDRH, 2021). Temporary treatments include bracing and this does not provide any type of long term relief to the patient (CDRH, 2021). The risks of the device in the summary of safety and probable benefits were found to be less than the benefits of the device (CDRH, 2021). The device was also proven to be safe in clinical studies allowing it to be approved via a Humanitarian Device Exemption (CDRH, 2021). 

Summary 

The Patient Specific Talus Spacer was approved as a Humanitarian Use Device as it fits the requirements needed for a Humanitarian Device Exemption. The device’s application demonstrated that the risks associated with the device do not outweigh the benefits to patients affected by Avascular Necrosis in the ankle. 

Center for Devices and Radiological Health (CRDH). (2019). Humanitarian device exemption. U.S. Food and Drug Administration. 

Center for Devices and Radiological Health (CDRH). (2021). Patient specific talus spacer – h200001. U.S. Food and Drug Administration. 

Joseph, T. (2021). Avascular Necrosis. Cedars Sinai. 

Paragon. (2021). Humanitarian device EXEMPTION (HDE). accessdata.fda.gov. 

#2 Patrick Question Response Needed

Introduction

Throughout history we have seen cases of rare diseases or conditions that affect fewer than 200,000 people (Center for Devices and Radiological Health, 2019). To combat these rare diseases or conditions, Congress included the Humanitarian Device Exemption (HDE) program into the the Safe Medical Devices Act of 1990 (Kahan, J. S., et. al., 2020). This program was intended to create new treatments of a disease or condition that affects smaller populations (Center for Devices and Radiological Health, 2019).  Since this was added, there have been many Humanitarian Use Devices (HUD) that have been approved by the FDA. One device that was approved in 16 JUL 2015 was Osseoanchored Prostheses for the Rehabilitation of Amputees also known as OPRA (SSPB, 2015).

Key Points

When a person suffers from a trauma or cancer, under certain circumstances, that patient may undergo an amputation of a limb. When this happens there are chances of infections, pain, soft tissue scarring, etc., whatever the case, these can present challenges when getting fit for socket prosthesis (SSPB, 2015). A socket prosthesis is used for patients that have undergone an amputation, however, OPRA was designed as another option (SSPB, 2015). OPRA is a device intended for patients who have had transfemoral amputation and because of a condition that occurred after the amputation, such as skin infection, soft tissue scarring, etc., they cannot use a conventional socket prosthesis (SSPB, 2015). Unlike conventional socket prosthesis, which can attach to the stump or limb, it is designed to have a metal fixture surgically attached to the bone of the thigh and then attaching the prosthesis to the fixture that was attached to the bone (SSPB, 2015), thus allowing them the option of having a prosthesis.

Having a leg amputated can have a huge impact on a person’s everyday life. When they make the choice to get a prosthesis, there is a chance they won’t be able to because the stump possibly being  too short or because of a possible reoccurring skin infection. This can be very discouraging and pose a challenge for them in the future. OPRA was designed and then approved for this matter. According to Humanitarian Device Exemption (HDE), to be approved, the HUD must meet certain requirements. One of those requirements is, “would not be available to a person with such disease or condition unless the agency grants the exemption and there is no comparable device” (Kahan, J. S., et. al., 2020). OPRA meets this requirement because if the FDA were not to accept this device, people who have had a leg amputated above the knee and suffer some conditions following the surgery, might not be able to get a prothesis. By approving this device, they allow individuals another option of getting a prothesis that offers minimal risks; and if any risks were to occur, it is easy for the surgeon to remove the metal fixture.

Center for Devices and Radiological Health. (2019, September 5). Humanitarian Device Exemption. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/premarket-submissions/humanitarian-device-exemption (Links to an external site.)

Kahan, J. S., & Heyl, M. S. (2020). Medical Device Development: Regulation and Law (4th ed.). Parexel Intl Corp.

SUMMARY OF SAFETY AND PROBABLE BENEFIT (SSPB). (2015, July 16). FDA.Gov. https://www.accessdata.fda.gov/cdrh_docs/pdf8/H080…

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