Breakthrough Device

Med Device Monday- Optimizer Smart system is a Breakthrough Device that aims to treat Chronic Heart Failure

Image from https://www.impulse-dynamics.com/int/patients/ccm-and-the-optimizer-system/

Image from https://www.impulse-dynamics.com/int/patients/ccm-and-the-optimizer-system/

In March, the Optimizer Smart system from Impulse Dynamics received Breakthrough Device designation. The device is intended to treat individuals suffering from moderate-to-severe Chronic Heart Failure, and for whom treatment with other heart failure devices is not suitable. FDA gave the Optimizer Smart system its Breakthrough Device designation because the device treats a life-threatening or irreversibly debilitating disease, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

Chronic Heart Failure (CHF), also known as congestive heart failure, occurs when the heart is unable to pump enough blood through the body to ensure a sufficient supply of oxygen. As a result, individuals with CHF may experience breathlessness and exhaustion, as well as swollen ankles and legs. Chronic heart failure is a serious long-term condition that generally gets worse over time, however its progression is very unpredictable and individual prognoses can vary greatly. The causes of CHF are many, and often a number of problems will affect the heart at the same time. A heart’s reduced ability to pump blood can be caused by an inherited genetic defect, an infection, high blood pressure, heart rhythm problems, coronary heart disease, or other diseases that have caused the walls of the heart chambers to become stretched, thickened, or stiff.

Measuring how well someone’s heart is pumping blood can help to diagnose and track heart failure. Physicians will often measure the heart’s ejection fraction, or how much blood the left ventricle pumps out with each contraction. Normally, the ejection fraction will be 50-70%, but if that percentage dips below 50%, a patient may notice they become breathless during activities and are more easily fatigued. In patients with CHF, the ejection fraction percentage can often drop below 40%, with symptoms of heart failure being experienced while performing everyday tasks, and even while at rest.

The Optimizer Smart system was developed to alleviate symptoms in patients for whom other treatments are not suitable or have been shown to be ineffective. There are several different components to the medical device: the Optimizer Implantable Pulse Generator (IPG), the Optimizer Smart Charger system, the OMNI II Programmer System, and the Omni SMART Software. The IPG is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart. After the device is implanted, a physician tests and programs the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability, or ejection fraction. The IPG can be recharged on a weekly basis without any clinical guidance or supervision, and the OMNI II System and Software allow medical personnel to track and then modify the device to meet an individual patient’s needs. The circumstances surrounding each case of CHF are unique, and the software’s ability to tailor the treatment delivered by the device aims to improve the patient’s quality of life.

During two randomized, multi-center clinical trials, a total of 389 patients with moderate-to-severe heart failure received optimal medical therapy, with 191 of those patients also receiving an Optimizer Smart system implant. Patients receiving the implant showed improvements in the distance they were able to walk in physical fitness tests, as well as improvements on standard assessments to measure heart failure symptoms. Patients fitted with the Optimizer Smart system implant reported a decrease in how much CHF symptoms affected their quality of life and how much the symptoms impeded daily physical activities compared to those who received only medical therapy.

Chronic Heart Failure is unfortunately very common, affecting more than 25 million people worldwide, most of them over the age of 65. Drugs or implanted devices, including pacemakers and implantable cardiac defibrillators, are sometimes enough to treat the symptoms associated with heart failure, however these solutions do not always mitigate symptoms. For these patients, there has been little physicians can do to treat their CHF. With the introduction of the Optimizer Smart system, physicians can now offer these patients an implant with the potential to relieve symptoms, prevent a worsening of their condition, reduce time spent in the hospital, and improve the length and quality of their lives…all news that makes our hearts very happy!


Additional Reading:

  1. Impulse Dynamics Website

  2. Video explaining how Optimizer Smart works

  3. Optimizer Brochure

  4. FDA News Release

Med Device Monday: Aethlon's Hemopurifier

Today is our fourth and final post in our October series, and today we’re talking about another Breakthrough Device  that has yet to hit the U.S. market. And since it’s almost Halloween, what a perfect time to talk about Dracula’s favorite topic: blood! The Aethlon Hemopurifier® is a first-in-class device developed for rapid elimination of circulating viruses and cancer-promoting-exosomes from the body. In simpler terms, the device acts like a filter by straining out impurities— in this case, viruses and cancer cells— from the blood. The device has been awarded the breakthrough status because it fulfills one of the conditions for the breakthrough designation; namely, its ability to provide a more effective treatment for a life-threatening or irreversibly debilitating human diseases.

The hemopurifier is a one-time use, disposable cartridge that can be attached to dialysis and other blood circulatory equipment commonly used in health care settings. The entire circulatory system of a patient can pass through the cartridge about one time every 20 minutes. The cartridge consists of a biocompatible plasma membrane (with 200 nm diameter pores) coated with a plant-derived lectin known as Galanthus nivalis agglutinin (GNA). GNA binds to polymeric structures called glycans found on the surface of the viruses and exosomes, capturing them, and keeping them from re-entering the patient’s circulatory system. Viruses and exosomes are known to use this “glycan shield” in order to camouflage and subvert the body’s immune system. GNA selectively binds to a broad spectrum of infectious viruses while having limited interactions with most human proteins. You can really put this into perspective and understand how incredible this is when you evaluate the other anti-viral drug regimens that are used today, and the prolonged amount of time patients must participate in those regimens. Studies have shown that GNA is capable of inhibiting many viral pathogens such as Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Dengue Virus, Ebola Virus and Severe Acute Respiratory Syndrome Coronavirus.

Image from www.aethlonmedical.com

Image from www.aethlonmedical.com

Recently, we have seen the emergence of new viruses and the reemergence of old viruses that cause severe and fatal infections. The increase of these viruses is often induced by international travel, global warming, and densely populated urban environments. The majority of these viruses have no vaccines or treatments available, and depend solely on the body’s immune system to fight off the infection. Ebola, Zika, and Chikungunya are examples of such viruses capable of causing lethal infections for which no approved treatments exist. The outbreak of Ebola and Zika infections in the recent past are reminders of the need to develop therapies to prevent future epidemics.

Aethlon hemopurifier therapy has been successful in curing patients infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In 2014, the device was successful in treating a comatose Ebola-infected physician. In fact, a single administration of the hemopurifier therapy was successful in saving the patient with multiple organ failure. This led to Time Magazine naming the Hemopurifier as one of the "Top 25 Inventions," as well as one of the "Eleven Most Remarkable Advances in Healthcare." The company is currently conducting pre-clinical studies on mosquito-borne viruses like Chikungunya, Dengue, and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection.

Hemopurifier therapy is also being applied to the capture of exosomes. Exosomes are vesicles that are released by cells into the circulatory system where they are distributed throughout the body. They have been implicated in intercellular communication and the transmission of certain diseases within the body. Compared to normal cells, tumor-derived exosomes (TEX) are released by cancer cells in exponentially greater numbers. TEX is associated with cancer progression, immune suppression and chronic inflammation. In fact, 90% of all cancer-related deaths are attributed to metastasis involving exosomes. Moreover, studies have shown that TEX is resistant to a wide range of anti-cancer drugs. In addition to their role in cancer metastasis, exosomes have also been implicated in the progression of Alzheimer and Parkinson’s, as well as numerous inflammatory diseases. Thus, therapeutic approaches targeting the exosomes, such as the hemopurifier therapy, address a significant unmet need in the medical field.

It is devices like the Hemopurifier that FDA aims to safely get on the U.S. market. Breakthrough Devices often offer solutions for diseases where no cleared or approved treatments exist, or they provide significant advantages over already-existing therapeutic approaches. Clean blood is something both patients and Dracula can smile about!

Have a safe, effective, and happy Halloween, everyone!


Additional Reading

  1. Aethlon Medical Website

  2. Press release for Athleton Breakthrough Status

  3. Breakthrough Devices Program

  4. Info about Dracula

Med Device Monday: Breakthrough Device VectRx by NeoTherma Oncology

How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)

Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!

The next device in our series is called VectRx™, a Thermal Treatment (TTx) system being developed as an adjunct therapy for solid tumors. This device comes from Kansas-based device maker, NeoTherma Oncology, and has been granted FDA breakthrough device designation for treatment of pancreatic cancer. The company prides itself in providing a “more effective and more humane solution for treating cancer.”

From the www.neothermaoncology.com website:

“Our technology is based on applying a safe, non-invasive, nonionizing electromagnetic field to produce local ‘fever-range’ temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. The energy emitted by our TTx device increases blood perfusion in tumor micro-environment, reversing the treatment-resistant hypoxia, and promoting a therapeutic immune response.”

Hold up…let’s back up a minute and talk about cancer…chances are, you or someone you know has been directly affected by this disease. According to the American Cancer Society’s recent report, in 2018 alone there will be an estimated 1,735,350 new cancer cases diagnosed and 609,640 cancer deaths in the United States. This disease is defined as the uncontrolled division of cells in the body. Many cancers form solid tumors, which are abnormal masses of tissue, and can either be benign (non-cancerous) or malignant (cancerous). Solid tumors are named for the type of cells that form them, and include sarcomas, carcinomas, and lymphomas. Treatment for solid tumors is generally a combination of surgery, chemotherapy and radiation therapy.

Pancreatic cancer — statistically known as the deadliest of the solid tumors — is the fourth leading cause of cancer-related death in both men and women. The NIH based National Cancer Institute estimates that 55,440 new cases of pancreatic cancer will be diagnosed and 44,330 deaths will be associated with the disease this year. Last year there was an estimated 43,090 deaths caused by this type of cancer and researchers place the 5-year relative survival rate at a meager 8.5%. Radiation therapy and chemotherapy are currently the main treatment options for pancreatic cancer. Unfortunately, less than 20% of patients are candidates for surgery because pancreatic cancer is often detected well after it has spread beyond the pancreas. Enhancing the efficacy of existing therapies is one crucial way that scientists and doctors can improve treatments for this deadly cancer. With all these stats in mind, it’s not hard to see why FDA designated this product as a Breakthrough Device. It clearly meets the first criterion that states it “provide a more effective treatment for a life-threatening or irreversibly debilitating human disease” [emphasis added].

Cancer.MagnifyingGlass

As mentioned above, the VectRx device provides a radio frequency thermal treatment to raise the temperature around the tumor from 37°C to ~42°C. This localized increase in temperature at the tumor site can support the chemotherapy treatment by increasing the blood flow around the tumor (thus enabling the drugs to penetrate the tumor at lower doses). Warming up the tumor site also likely provokes a therapeutic immune response by increasing the tumor cell surface proteins. Helping make the chemotherapy drugs more efficacious while making you feel less cruddy, along with triggering the body’s natural defense system to attack the tumor, equates to a serious ‘one-two punch’ combination in this fight against cancer! It’s exciting to know that VectRx works at increasing the efficiency of the available treatments, while simultaneously minimizing the harsh effects that those treatments have. The device is being developed for treatment of a wide range of cancers, but the lead target for the company right now is pancreatic adenocarcinoma.

Although surgery, radiation therapy, and standard chemotherapy will continue to play an important role in treating cancer, the emergence of novel adjunct therapies like VectRx will expand the treatment options available to cancer patients. We’re excited to see how FDA and NeoTherma Oncology work together to bring this potentially game-changing treatment to the US market.

Additional Reading:

1.       More info about NeoTherma Oncology

2.      Press Release about VectRx’s Breakthrough Designation

3.      More info about Pancreatic Cancer from NIH National Cancer Institute

4.     NeoTherma Oncology secures grant from National Cancer Institute