Med Device Monday: Recall of the Raindrop Vision Inlay Device

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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

MDMonday: NERV Technology's Implantable Biosensors

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!

This week we’re focusing on an implantable biochip by a company called NERv Technology Inc. This bioresorbable chip aims to help detect postsurgical complications by identifying internal bleeding, leakage of bodily fluids, and infection within the abdominal cavity. As described at the website:

“NERv’s biosensors are predictive. They collect data and identify a specific kind of complication as soon as it develops. The biosensors provide information before the complication reaches a critical stage. NERv’s biosensors provide a preventative approach to post-operative care by identifying a complication as it is developing and preventing the development of further complications.”

A medical device that might be able to predict the future in order to prevent critical post-operative complications!? Someone call Tom Cruise and let him know Minority Report needs a remake!

Postsurgical Complications

Over 7,000 individuals die every year due to the failure or late detection of post-operative complications. Postsurgical or post-operative complications can result from the operation itself or other unrelated factors. Post-operative complications cause longer hospital stays and increased healthcare costs, not to mention the suffering that many patients (and their families) may go through. While it depends on the surgery, some common complications include pneumonia, internal bleeding, deep vein thrombosis, infection, and pulmonary embolism. The clinical signs of disease are often blurred in the postoperative period. Early detection of postoperative complications requires repeated evaluation of the patient by the operating surgeon and other team members, which can be time consuming and laborious for everyone involved. Additionally, some of these complications take days or weeks to show up, often well after you’ve gone home to recover. The current methods for detecting post-operative complications include imaging techniques like CT and MRI scans, as well as lab tests which are only performed once the patient has demonstrated certain symptoms…and these all of course take you out of your comfy recovery chair at home and bring you back to the hospital. Which is good if you do need to go to the hospital, and not-so-good if it turns out to be an unnecessary visit.

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How does the device work?

The NERv biochip is about the size of a shirt button, and is implanted into the body during surgery. As soon as a complication develops post-surgically, the chip is able to detect it and collect information about its status. The data are sent to a receiver located in a trans-dermal patch placed on the wound after surgery. While the patient may receive a simple alert notification so that they are able to seek medical care right away, the physician will get a more detailed analysis of the patient’s status. The biosensors in the chip have demonstrated to be very sensitive; able to detect even small changes of specific biomarkers associated with these complications. Physicians will also be able to get information on the kind, location, and severity of the complication. Made of bioresorbable materials, the biochip sticks around for a month before it is broken down by the patient’s body, thus avoiding another surgery to have it removed.

We’re excited to see medical devices like this being developed! We look forward to keeping tabs on NERv…and watching this technology get to market and safely into patients!

Additional Information:

1. NervTech Website

2. NERv Illustration Animation

MDMonday: MiniMed 670G Glucose Monitor and Insulin Pump for Pediatric Populations

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In September of 2017, FDA approved a device for patients with type 1 diabetes aged 14 and up. The device, called the MiniMed 670G, is a hybrid, closed-loop system that provides automated insulin delivery with little to no input from the user. The system includes a glucose-measuring sensor that attaches to the body, an insulin pump that straps to the body, and an infusion patch that connects to the pump with a catheter. This catheter is the way through which the insulin is delivered. Very recently, FDA expanded the approval of this device for use in younger pediatric patients, which now include children aged 7 to 13 with type 1 diabetes.

In patients with diabetes, the body’s ability to make or react to insulin is impaired, and doesn’t function correctly. The pancreas makes little or no insulin in people who have type 1 diabetes. This means that they must keep track of their glucose levels throughout the day, and inject insulin at certain points so they can avoid high glucose levels. FDA Commissioner Scott Gottlieb, M.D. recognizes the struggle for patients with type 1 diabetes, and stated, “Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives.” The MiniMed 670G helps to combat hypoglycemic episodes by measuring the glucose levels of the user every five minutes, and automatically adjusting insulin levels by either withholding insulin or administering it. While the device can adjust insulin levels automatically, users must manually request insulin to counter the consumption of carbohydrates at any mealtime.

For this approval, FDA analyzed data from clinical trials of the MiniMed 670G that spanned 105 individuals, aged 7 to 11 years of age. Each participant wore the device for just over three months, and participated in three different phases of the study so both at-home use and remote use could be monitored. At the conclusion of the study, no serious adverse events were found associated with the MiniMed 670G, and it was determined that the device was safe for use in those aged 7 to 13 with type 1 diabetes. FDA Commissioner Scott Gottlieb, M.D. states that, “Advances in science, technology and manufacturing are contributing to the development of new and expanded uses of products that can help improve the quality of life for those with chronic diseases, especially vulnerable populations, like children. Today we’re extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks. The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and to ensuring that the path to market is both efficient and effective.”

Getting treatments to pediatric populations has been an ongoing goal for both FDA and industry. Historically, medical device manufacturers and investors have been wary of expanding their products to children as the risk was seen to be too great. Nobody wants to see injured kids due to a medical's bad for business and clearly bad for the children, their families, and their healthcare providers. With this in mind, FDA has implemented policies in the past few years (e.g. sections of the 21st Century Cures Act) that helps industry help children. Getting much needed technology scaled to be appropriate for children is critical to help these populations get the treatment they need! We applaud medical device manufacturers who are (safely) working on treating these vulnerable populations.

Further Reading:

  1. FDA and Pediatrics

  2. 21st Century Cures Act: Sections that Impact FDA

  3. Press Announcement about MiniMed670G Approval

Medical Device Monday: Gore Cardioform Septal Occluder Supplement

Back in 2006, FDA approved a medical device called the GORE®CARDIOFORM Septal Occluder (Yes, Medical Device Monday typically covers new devices but just bear with us for a second). The GORE®CARDIOFORM Septal Occluder is a heart implant used to close a hole in the heart called patent foramen ovale, or PFO. Recently, the creators of GORE®CARDIOFORM applied to have a supplement to the device approved by the FDA, and we are here this week to tell you that that supplement has been approved. Before we get into what exactly the supplement is, let’s dive a little deeper into what the device does.

First off, there are two different kinds of holes you can have in your heart. One is called an atrial septal defect (ASD), and the other is a patent foramen ovale (PFO). ASD is a congenital heart defect defined by the failure of the septal tissue formation between the right atrium and the left atrium, which are the two upper chambers of the heart. While ASD can occur before birth, PFO can only occur after birth, when the foramen ovale fails to close. This naturally-occurring hole allows blood to circumvent the fetal lungs, which are non-functional until birth. When a baby is born and takes its first breath, the foramen ovale is supposed to close, and within a few months seals completely. However, should it fail to close the the patient is said to have PFO. This occurs in about 25 percent of the normal population with no adverse health effects. In fact, most people with the condition don’t even know they have it! PFO causes small amounts of blood to leak from the right side to the left side of the heart, which can create problems especially if the blood contains a blood clot that could lead to cryptogenic stroke.

To help combat this, the GORE®CARDIOFORM Septal Occluder device consists of an occluder which is implanted in the heart with the help of a delivery catheter (a small tube). The occluder is made of self-expanding Nitinol wire frame, which is covered with a thin ePTFE membrane. The ePTFE is coated with a hydrophilic substance to enable echocardiographic imaging of the occluder and surrounding heart tissue during implantation. The occluder is shaped as two discs connected in the center that makes contact with the walls on both sides of the PFO to stop the leakage of blood between the atria. The occluder can be compacted to a small size to allow it to pass through the delivery catheter to be implanted within the heart. The occluder is delivered at the PFO site using conventional catheter delivery techniques wherein the catheter is inserted through the vein to reach the heart. At the site, the occluder expands where one disc covers the right and the other disc covers the left side of the PFO. Once implanted, the occluder helps block shunting of the blood from the right to the left atrium. The supplement that has been recently approved by FDA was the expansion of the indications to include closure of the patent foramen ovale to reduce another type of stroke, recurrent ischemic stroke. Ischemic strokes occur as a result of a blockage within a blood vessel that supplies blood to the brain, and can lead to extensive brain damage.



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The GORE®CARDIOFORM Septal Occluder is indicated for use in adult patients who have had a previous episode of cryptogenic stroke and are on blood-thinners (such as aspirin) to prevent another stroke. In a multinational clinical study published in the New England Journal of Medicine, there was a 77% reduction in recurrent stroke for cryptogenic stroke patients treated with the GORE CARDIOFORM Septal Occluder plus blood-thinning medication, as compared to blood-thinning medication alone. 

This is a great example of a device that is able to expand its indications after new clinical data surfaces. Congrats to Gore Medical and to those patients who avoid devastating brain damage thanks to this technology!

Click here for a video from the company website explaining the placement of the device.


Suggested Reading:

  1. Approval Letter

  2. Summary of safety and effectiveness

  3. Company website

  4. FDA news release



Med Device Monday: Implantable Continuous Pump for Remodulin

Imagine you have a condition where your body doesn't produce enough of the chemical that keeps your blood vessels open and clear, instead allowing them to thicken. This of course impacts the amount and flow of oxygen you're getting and thus affects your heart and lungs. Imagine that there is, fortunately, a treatment for this. But treatment requires regular visits to medical professionals for IV drips or shots, to keep your body functioning and battling this condition. You go because these visits are helping keep you alive. But what if you could just have the whole system implanted and skip most of those visits, constant monitoring, frequent skin punctures, and some of the possible side effects? Well, now you can. 

Pulmonary arterial hypertension (PAH) is a progressive disease where they body doesn't make enough prostacyclin, which allows the pulmonary system to function properly. Remodulin (treprostinil) is a drug that can treat this condition, but which needs to be regularly administered. A new system recently approved by FDA allows the whole thing to be implanted and doses administered automatically via an IV catheter, thus improving quality of life: the Implantable System for Remodulin is a fully implantable system designed to deliver Remodulin® (treprostinil) injection intravenously for the treatment of patients with pulmonary arterial hypertension (PAH). 

Remodulin is stored in the pump reservoir and, per a programmed prescription, moves through the pump tubing, the catheter port, and the catheter to the intravascular delivery site. The programmer is a handheld device that is used to review and program pump parameters using telemetry, a radio frequency (RF) communication. The physician or healthcare provider usually calibrates this at a first visit. Subsequent visits are of course required, but the level of maintenance versus routine IV drips or injections is considerably less.

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The American College of Cardiology sums it up well: "The most notable benefit of the implantable system is that it significantly reduces the rate of BSIs [blood stream infections] and site infections versus that associated with external IV systems. It also eliminates chronic treprostinil-induced infusion site pain associated with SC administration. By reducing the rate of catheter-related complications and pump user errors that cause drug interruptions or overdose, it improves the consistency of therapy. Finally, it improves patient's quality of life by eliminating the daily burden of system management, and reducing restrictions and fear during normal activities of daily life. The majority (93%) of patients rate the implantable system as "very good" or "excellent"."

The Implantable System for Remodulin, which is marketed by Medtronic, is made up of 3 parts:

·      The pump (Medtronic SynchroMed II 8637P Programmable Pump)

·      The catheter (Medtronic 8201 Implantable Intravascular Catheter)

·      The programmer (Medtronic N’Vision 8840 Clinician Programmer with 8870 Application Card)

The pump is implanted by the surgeon in the subcutaneous pocket using an incision in the lower abdomen. The intravascular catheter is connected to the pump and inserted through a vein at the superior caval-atrial junction which is the junction between the superior vena cava and the right atrium of heart. The pump reservoir remains permanently implanted and the health care provider uses a needle and syringe refill kit to refill the pump with Remodulin by a percutaneous procedure. 

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This medical device does come with some parameters. Restrictions for The Implantable System for Remodulin should not be used in the following patients, including NYHA Class IV heart failure patients; patients who cannot tolerate a sudden cessation of Remodulin therapy; patients with a known or suspected infection, bacteremia, or sepsis requiring antibiotics; patients with vasculature that is inadequate for an 8 French introducer or catheter advancement without stylet guidance; patients implanted with leads or catheters (active or abandoned) in the superior vena cava that cannot be removed prior to or at system implant; patients whose body size is not sufficient to accept pump bulk and weight; patients with skin or soft tissue that would heal poorly, increase susceptibility to infections, or is unacceptable for implant of this system; patients for which a health care provider cannot implant the pump 2.5 cm or less from the surface of the skin.

It's interesting and exciting to see how medical devices can make for new versions of existing successful therapies. This implantable system is a great example of how quality of life can be improved via medical device technology without having to reinvent the proverbial wheel.


Further reading:

Remodulin Implantable FDA Approval

Remodulin Implantable FDA Approval Letter

Remodulin website