Med Device Monday

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 – CureMetrix “Triage” Service cleared to Screen Mammograms for Signs of Cancer

Image from https://www.sandiegouniontribune.com/

Image from https://www.sandiegouniontribune.com/

It is estimated that one in eight women will be diagnosed with breast cancer during their lifetime. Generally, the first noticeable symptom of breast cancer is a lump that feels different from the rest of the breast tissue. In fact, more than 80% of breast cancer cases are discovered when the woman (or man…men get breast cancer too!) feels a lump. Finding breast cancer early can mean improved chances that the disease can be successfully treated. Fortunately, mammograms are often able to detect breast cancers early, and involve a simple low energy x-ray of the breast.

The use of mammograms as a screening tool for the detection of early breast cancer in otherwise healthy women is not without controversy. A mammogram that generates a false positive can cause significant stress and lead to unnecessary surgical interventions, and mammography can also generate false negatives. It is estimated that the numbers of cancers missed by mammography is ~20%, either due to observer error or because the cancer is hidden by other dense tissue in the breast. While mammograms do save lives, improved mammography could lead to earlier and more accurate detection of breast cancer.

Which is why we were excited to see FDA clear CureMetrix to sell its software “triage” service to screen mammograms for signs of cancer. CureMetrix is based here in San Diego, and in March 2019, the company was given the green light to market cmTriage™, which according to the company’s website is “software intended to provide a notification triage code to the radiologist’s mammography work list based on the presence of a suspicious region of interest found by the underlying algorithm. This workflow optimization tool enables a radiologist to customize their mammography work list based on cases that may need immediate attention.”

According to CureMetrix CEO Kevin Harris, “the cloud-based service sends back the results in three to four minutes. What we’re seeing in preliminary studies is the triage software can help doctors read through their work list up to 40 percent faster.” In addition to having an impact on clinical efficiency, CureMetrix says radiologists can elect to get immediate notification of suspicious results, so patients can be made aware of a concern before they have even left the clinic.

We are definitely seeing more companies like CureMetrix, focused on leveraging artificial intelligence and deep learning to develop the next generation of medical image analysis technology, and FDA is working hard to keep pace. FDA recently published a Discussion Paper and Request for Feedback on the topic of Artificial Intelligence and Machine Learning in Software as a Medical Device. FDA is considering a total product lifecycle-based regulatory framework for these technologies that would allow for modifications to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained.

Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Information is power…we just have to figure out how to harness it to better assist health care providers and improve patient care!

Further Reading:

  1. CureMatrix Website

  2. CureMatrix cmTriage™ Letter

  3. More Information on Breast Cancer – American Cancer Society

  4. What is a Mammogram – CDC

  5. Artificial Intelligence and Machine Learning in Software as a Medical Device



Med Device Monday – De Novo Clearance of The Miris Human Milk Analyzer

Breast milk is often considered a “superfood” for babies; it contains the appropriate vitamins, minerals, and nutrients to support a baby’s growth and development (not to mention hormones and enzymes that promote maturation and digestion, and antibodies that help the baby resist infection!). It’s no wonder why breast milk is often referred to as “nature’s first health plan.”

Yet for infants born preterm (before 37 weeks gestation), or with certain health conditions, breast milk may not contain sufficient protein or provide enough energy. For these infants with increased nutritional needs, knowing the macronutrient content of the breast milk being provided could give vital information to the health care team and parents, allowing them to make informed decisions on how to fortify the breast milk based on the individual needs of the infant.

In December 2018, the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer (HMA) to Miris AB of Sweden. The Miris HMA uses an infrared spectroscopy system to analyze samples of human milk, and provides a quantitative measurement of fat, protein and total carbohydrate content, as well as calculations of the total solids and energy content contained in the milk. The prescription device is intended for use by trained health care personnel at clinical laboratories, providing healthcare professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

FDA reviewed the Miris HMA test through the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with its granting, FDA established a list of special controls to provide for the accuracy and reliability of tests intended to measure the nutritional content of human milk to aid in the nutritional management of certain infants. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. As discussed in our previous blogs about the De Novo pathway, this action also creates a new regulatory classification; meaning subsequent devices of the same type and intended use may go through FDA’s 510(k) process.

Already on sale in over 25 countries worldwide, the Miris HMA is now available to analyze breast milk and guide the individual nutrition of preterm babies in the U.S. The new device supports Miris’ mission, “to make individual nutrition, based on human milk, available globally to improve neonatal health.” We’re excited to see a new device on the market that has the potential to help one of the most vulnerable patient populations. Go babies!


Additional Reading:

1.      FDA Press Release

2.      De Novo Letter for The Miris Human Milk Analyzer

3.      NIH: Do breastfed infants need other nutrition?

4.      CDC: Breastfeeding

5.      Miris Website

Med Device Monday: INNOVO – Therapy Device to Treat Stress Urinary Incontinence granted via the De Novo Pathway

Image from http://www.atlantictherapeutics.com/

Image from http://www.atlantictherapeutics.com/

Urinary incontinence is a very common, often ignored health issue. Stress incontinence is the most common type of urinary incontinence, and describes accidental leaks that occur when coughing, sneezing, laughing, jumping or doing heavy lifting. These simple movements, or stressors, put pressure on the bladder. Unfortunately, when the pelvic floor muscles are weak, this pressure can lead to a messy and potentially embarrassing leak. In women, stress urinary incontinence (SUI) can happen at any age, however it is most common during pregnancy, after childbirth, and during stages of menopause.

In November of last year, FDA granted a De Novo automatic reclassification to Atlantic Therapeutics’ INNOVO therapy device to treat stress urinary incontinence in women. INNOVO is a wearable device that may be prescribed as a front-line therapy to those suffering stress urinary incontinence, or as a second line therapy to those that previously failed physical therapy (in the form of supervised or unsupervised pelvic floor exercises, also known as Kegel exercises).

So, what exactly is a pelvic floor?

The term pelvic floor describes the group of muscles that span the bottom of the pelvis and support the pelvic organs. The pelvic organs in men (yes, men also have a pelvic floor) are the bladder and bowel, and in women they are the bladder, bowel and uterus. Weak pelvic floor muscles can lead to incontinence, pain, and prolapse, or the slipping down or forward of a pelvic organ. Honestly, we can’t think of anything good that comes from a weak pelvic floor.

According to the manufacturers, using a hand-held controller that is attached to a two-part garment, the INNOVO therapy device sends targeted impulses via conductive pads (attached to your upper thigh and buttocks) to activate the muscles of the pelvic floor. It is a technology that has been designed to optimally strengthen your pelvic floor with 180 contractions per session, allowing the device to do your pelvic floor exercises for you.

The device has demonstrated promising results. 87.2% of patients were dry or almost dry of after a 12-week treatment period, with 93% of patients experiencing improvement in as little as four weeks using the device five days a week for 30 minutes. One potential benefit of the device is that it is a transcutaneous electrical stimulator that offers a non-invasive choice to treat stress urinary incontinence. Elizabeth LaGro, Vice President of The Simon Foundation for Continence said it well, “INNOVO offers a new frontline therapeutic option for the millions of American women living with stress urinary incontinence, and in a significant group could delay or prevent the need for higher risk surgery or medical intervention.”

And finally, in addition to talking about a novel device coming soon to the US market, this week’s Medical Device Monday gives us the opportunity to again mention the De Novo pathway. In December, now outgoing FDA Commissioner Dr. Scott Gottlieb provided a high level description of the pathway; “the De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health”. In practice, the De Novo pathway is used for the review of novel, low to moderate risk devices for which there are ways to provide reasonable assurance of the device’s safety and effectiveness, but for which there is no existing predicate to use in the determination of substantial equivalence. So now, after years on the European market, women in the US will soon have access to INNOVO. We hope to see more US moms on trampolines in the near future!

Additional Reading:

1.      FDA Classification order

2.      Atlantic Therapeutics website

3.      Video explaining how INNOVO works

4.      Press release

5.      More info on SUI

Med Device Monday: Recall of the Raindrop Vision Inlay Device

wet eyeglasses.jpg

In April 2017, we wrote about a new device called the Raindrop Vision Inlay, manufactured at the time by ReVision Optics. Approved in 2016, the device is basically a small implantable contact lens that reshapes the front of the eye and corrects presbyopia, more commonly known as farsightedness. A little over two years later, the Raindrop Vision Inlay was the subject of an FDA Safety Communication recommending patients not receive the device. After post-market research, FDA identified an increased risk of corneal haze, or the development of a cloudy layer within the eye that impairs overall vision. Shortly thereafter, in November 2018, FDA issued a Class I recall - the most serious type of recall - reserved for devices that may cause serious injuries.

So, what happened?

Going back to 2016, the Raindrop Vision Inlay was given FDA approval in large part due to a two-year clinical trial that yielded promising results, including high numbers of patients who could read smaller print at closer distance post-op. At the time of device approval, the clinical study showed that while 16.1% (60 of 373) of patients had central corneal haze of any severity at some point during follow-up, the percentage of patients with two or more lines of loss in vision on the eye chart caused by corneal haze was 1.1% (4 of 373 patients). The number of patients who had the device removed was 24 of 373 patients (6.4%) at the two-year follow-up visit, with 29% of those device removals (7 of 24 patients) being due to corneal haze.

The Raindrop Vision Inlay was marketed under the conditions that the device be restricted to prescription use and specifically labeled to define the training or experience practitioners needed in order to implant the device. Marketing of the device was also conditional on the reporting of results from two post-approval studies (PAS), one that followed patients enrolled in the original clinical study, and a second that tracked newly enrolled patients. Of the 373 patients from the original study, 150 were enrolled in the PAS. The most recent data from the ongoing study, including 5 years of follow-up in some patients, showed that the rate of central corneal haze, at any time during the study, was 42% (63 of 150 patients), and that the presence of haze at any location within the cornea was a whopping 75% (113 of 150 patients). The percentage of patients with two or more lines loss on the eye chart caused by corneal haze remained low at 2.0% (3 of 150 patients), however that was greater than what was observed during the original clinical study. After evaluation of the PAS data, the risks outweighed the benefits of the device and lead the company and FDA to initiate the recall.

It is awful that the Raindrop Vision Inlay caused any patients implanted with the device to suffer, and one might be quick to judge that FDA ‘screwed up’ by allowing an unsafe device to be sold. The whole story is quite a bit more complicated, however, and we feel the Raindrop Vision Inlay situation is an example of FDA working to uphold its mission. In this situation, FDA took responsibility for both helping speed innovation that would potentially improve patient’s lives, and for ensuring the safety and effectiveness of a medical device before and after market approval.

FDA closely monitors reports of adverse events and other problems with medical devices, and alerts health professionals and the public when needed to ensure their proper use. FDA has stated that it is currently working with the owner of the Raindrop Vision Inlay, Optics Medical, on a plan to collect any remaining devices already distributed. FDA will continue to gather and evaluate data related to the recalled device, and communicate new information as warranted.

Further Reading:

1. FDA Safety Communication

2. Raindrop Vision Inlay PMA Approval Letter

3. Summary of Safety and Effectiveness Data

4. Raindrop Vision Inlay Recall Notice