FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.

The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.”  According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”

Now, two recent guidance documents issued by the FDA allow for altered 510(K) approaches for certain medical devices.  The first guidance, issued September 13, 2019, is for a “Special 510(K) Program.”  The FDA describes this program as “an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).”  The guidance is intended to clarify “the types of technological changes appropriate for review as Special 510(k)s.”  The new guidance also supersedes prior FDA guidance from 1998 regarding Special 510(k) policy in “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”

This MDDI article purports to offer a “handy checklist” to determine “if changes made to your medical device can be reviewed under the [Special 510(K)] program.”  Some of the questions listed on the article’s checklist include the following:

  • Is it a change to the manufacturer’s own device?
  • Are performance data needed to evaluate the change?
  • Is there a well-established method to evaluate the change?
  • Can the data be reviewed in a summary or risk analysis format?

The second FDA guidance, also issued September 13, 2019, is for the “Abbreviated 510(K) Program.”  The FDA describes the program as “an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s)” and that “uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.”   The guidance is “intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.”

A copy of the guidance for the Special 510(K) Program can be found here, and a copy of the guidance for the Abbreviated 510(K) Program can be found here.   The FDA currently states that comments on either guidance may be submitted at any time.  Public comments on the guidance for the Special 510(K) Program may be submitted here and for the Abbreviated 510(K) Program here.

PTAB Institutes Inter Partes Review of Medtronic “Jervis” Patent

On June 11, 2019, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc.  The Decision instituted the IPR based on two obviousness grounds, including that “Petitioner has made an adequate showing at this stage that at least claim 1 would have been obvious over Cragg, Pops, and Tanaka.”

As previously reported on KnobbeMedical, the petition that lead to institution of the IPR was filed on November 9, 2018 by Cook Medical LLC.  The status of the proceeding can be examined by searching for the patent on the Patent Trial and Appeal Board website.

The ‘141 Patent is entitled “Medical Devices Incorporating SIM Alloy Elements.”  The ‘141 Patent states that it relates to “a medical device containing a shape memory alloy element.”  The ‘141 Patent claims priority to a 1983 filing. The USPTO’s Certificate Extending Patent Term for the ‘141 patent indicates that it will expire on April 15, 2022.

The ‘141 patent discloses using stress to restrain a metal alloy in a stressed state (“stress induced martensite” or “SIM”).  The alloy expands to its unstressed shape after being released from its restraint due to a phase change from martensite to austenite without a change in temperature.  In one example, the ‘141 Patent describes that the disclosed device enables doctors to treat damaged or diseased heart valves with a less invasive transcatheter heart valve procedure.  Figures 3 and 4 of the ‘141 Patent, shown below, illustrate a “side elevation view of a partial section of a catheter” in stressed (Figure 3) and unstressed (Figure 4) configurations.

This is not the first time that the ‘141 patent has been subject to a petition for inter partes review, but it is the first time that an IPR has actually been instituted.  On January 17, 2014, Edwards Lifesciences Corporation filed a petition with the Patent Trial and Appeal Board requesting inter partes review of all claims of the ‘141 Patent.  According to a Medtronic press release, on May 20, 2014, Medtronic and Edwards reached a “global settlement agreement” to “dismiss all of the pending litigation matters and patent office actions between them.”

In May 2013, Lombard Medical filed a petition for inter partes review of Claims 1-10 and 18-22 of the ‘141 Patent.  Lombard Medical’s products, according to its website, include the AORFIX™ endovascular stent graft.  According to a Lombard press release, on October 17, 2013, Lombard was granted a non-exclusive license by Medtronic to the ‘141 Patent, and Lombard formally requested a withdrawal of its inter partes review petition with the USPTO.

The ‘141 Patent has also been previously litigated.  The ’141 Patent, among others, was previously asserted by Medtronic against W.L. Gore & Associates, Inc. in 2006; Gore’s EXCLUDER® AAA, TAG, and VIABAHN SFA® endoprosthesis devices were at issue.  The parties entered into a confidential settlement in 2009.

Medtronic also previously asserted the ’141 Patent, among others, against AGA Medical in 2007.  AGA’s AMPLATZER® Septal Occluder, Duct Occluder, and Vascular Plug devices were at issue.  The parties entered into a settlement in 2010 in which AGA received a non-exclusive license to patents including the ’141 Patent in exchange for $35 million.  AGA Medical was subsequently purchased by St. Jude Medical in October 2010 for $1.3 billion.  St. Jude was in turn acquired by Abbott in 2016 for $25 billion.

 

New Motion Sickness Glasses Launched

In July 2018, Citroën, the French car manufacturer, unveiled glasses that aid in alleviating motion sickness.  The “Seetoën” glasses, developed by Boarding Ring, purports to eliminate motion sickness symptoms within about 10 minutes of putting them on.  According to Boarding Ring, the Boarding Ring technology includes four rings filled with blue liquid.

With the increase of use of smartphones and tablets, motion sickness has been affecting more people as more people look at screens while being transported around. Motion sickness affects up to 66% of the passengers depending on the vehicle. Motion sickness is thought to be caused by a mismatch between the visual information and the balance system’s perceptions. This situation can trigger motion sickness symptoms.

Currently, common remedies for motion sickness include focusing your eyes on the horizon, choosing your seat wisely to minimize motion (e.g., front or driver’s seat in a car, center of a boat, over the wings on a plane), avoiding alcohol and fatty foods, and taking medications such as Dramamine. But these remedies are not necessarily a complete fix. According to the Smithsonian, “some examples include a pair of blinders to block out visual information, a head mounted projection device meant to make visual information line up with sensory information, and shutter glasses that open and close rapidly, meant to prevent the visual slippage associated with motion sickness.”

As explained by Autoevolution, the lens-less glasses “create an artificial horizon line in the front and sides, which allows the resynchronization of sight and inner-ear, and thus ‘cures’ motion sickness.  Put them on and look at a fixed object, such as tablet or phone or book, and you should be able to remove them after 10 minutes[.] [Afterwards,] your motion sickness symptoms [will be] all gone.” The glasses use a concept that is similar as looking at the horizon when experiencing motion sickness at sea.  The horizon provides a stable reference point for our brains to focus on, thus alleviating the confusion that other senses create when sending confusing information to our brains. Alleviating motion sickness can be performed by putting on the Seetoën glasses as soon as symptoms start to occur. The Seetroëns can be worn over prescription lenses. Once symptoms disappear, one can simply remove the glasses and enjoy the rest of their trip.

However, there are critics who remain skeptical of the effectiveness of the glasses. Thomas Stoffregan, a professor of kinesiology at the University of Minnesota states that “[p]eople have been trying to use an artificial horizon in the context of motion sickness for several decades, at least since the 1970s …It’s never worked. My question to this company is ‘what’s different about your virtual horizon?’” In response, Boarding Ring’s CEO Antoine Jeannin says the Boarding Glasses are unique because they bring an artificial horizon to the peripheral vision—that’s why the glasses have four lenses—unlike other products, which only engage the central vision.

The glasses were invented by the father of Antoine Jeannin, Hubert Jeannin. According to the Smithsonian, “Hubert Jeannin patented his innovation in 2004 (the ’237 Patent) and tested the Boarding Glasses prototypes with the French navy, and, although the exact results are confidential, his son says it was extremely successful—some 95 percent of users found the glasses helpful within 10 minutes. Father and son now run the company together, with father handling innovation and son handling business.” According to Autoblog.com, early reviews of the spectacles come from boating magazines, and the specs received a special mention at the marine-focused 2013 DAME Awards.” Eventually, Citroën’s called upon Parisian design studio 5-5 to redesign the glasses with a fresh, simple, and ergonomic style.”

The Boarding Ring site has had the glasses available for preorder at a price of around $80 (£60, AU$107) with a shipping date of December 2018.

 

 

Boston Scientific Exercises Option to Acquire Transcatheter Annuloplasty Ring Developer Millipede Inc.

Global medical device company Boston Scientific has announced on December 27, 2018, that it exercised its option to acquire remaining shares of privately-held medical device company Millipede, Inc. upon its recent successful completion of a first-in-human clinical study.  Boston Scientific previously announced on January 24, 2018, an agreement to make a $90 million investment in Millipede.  The current press release states the prior agreement included an option for Boston Scientific to “acquire [Millipede’s] remaining shares for $325M at closing, with a $125M payment becoming available upon achievement of a commercial milestone.”

Millipede has developed a non-invasive solution for repair of the heart’s mitral valve.  According to Millipede’s website, Millipede’s IRIS Transcatheter Annuloplasty Ring System reshapes the mitral valve annulus of the heart to treat severe mitral regurgitation (MR).  MR is caused by a leaking mitral valve, which causes blood to flow backward from the left ventricle into the left atrium.  Over time, MR can lead to or accelerate heart failure and rhythm problems.  Millipede’s website describes the IRIS system as providing the gold standard in surgical heart valve repair – a complete annuloplasty ring implant.  The implant reshapes and reduces the mitral valve annulus opening, enabling return of leaflet coaptation and reduction of MR.

According to Millipede, the implant is delivered via catheter, for example through a small cut in the patient’s leg.  This allows patients to avoid invasive open heart surgery, which is necessary for implantation of conventional annuloplasty rings.  Millipede describes the transcatheter ring as repositionable and retrievable.

“We are very satisfied with the early results of our clinical program and are excited to see this technology further leveraged by Boston Scientific to expand the mitral repair solutions for patients around the world.” – Randy Lashinski, CEO, Millipede Inc.

Millipede is based in Santa Rosa, California and was founded in 2012 by majority investor Santé Ventures and Steve Bolling, MD, and has been led by CEO Randy Lashinski since 2014. 

Boston Scientific describes itself as a worldwide developer, manufacturer and marketer of medical devices, providing a broad range of high performance solutions that address patient needs and aim to reduce the cost of healthcare.

Millipede is a client of intellectual property and technology law firm Knobbe Martens.  With close to 275 lawyers and scientists nationwide, Knobbe Martens dedicates its practice to all aspects of intellectual property law including litigation and is consistently ranked among the top intellectual property firms worldwide.

A New Weapon against Obesity

A new study based on a novel implantable weight loss device that was published in Nature, has shown that it was able to help rats shed almost 40 percent of their body weight.  This implant device developed by engineers at the University of Wisconsin–Madison could offer a promising new weapon for the battle against obesity.  More than 700 million adults and children worldwide are obese, according to a 2017 study that called the growing number and weight-related health problems a “rising pandemic.”

According to articles, the device itself is minuscule – measuring less than 1 centimeter across.  The devices are said to be safe for use in the body and implantable via a minimally invasive procedure and is powered by the stomach’s natural churning motion.  The devices are also said to generate a gentle electric pulse to the vagus nerve, which links the brain and the stomach, and signals to the brain that the stomach is full even after a small snack.

“The pulses correlate with the stomach’s motions, enhancing a natural response to help control food intake,” says Xudong Wang, a UW–Madison professor of materials science and engineering.

According to the University of Wisconsin –Madison, “[u]nlike gastric bypass surgery, which permanently alters the capacity of the stomach, the effects of the new devices are reversible. When Wang and his collaborators removed the devices after 12 weeks, the study’s rats resumed their normal eating patterns and weight bounced right back on.”

Articles have stated that the new device also has several advantages over existing devices that stimulates the vagus nerve for weight loss. That existing unit, “Maestro,” approved by the Food and Drug Administration in 2015, administers high-frequency pulses to the vagus nerve to block all communication between the brain and stomach. The Maestro device also require batteries which frequently must be recharged.  In contrast, “Wang’s device contains no batteries, no electronics, and no complicated wiring. It relies instead on the undulations of the stomach walls to power its internal generators.  That means the device only stimulates the vagus nerve when the stomach moves.”

Medical Research Organization NAMSA Announces Acquisition of Reimbursement Strategies Consultancy

NAMSA, which describes itself as “the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services,” has announced the acquisition of Reimbursement Strategies, LLC.

According to Mass Device, “NAMSA is a medical device firm that “offers integrated laboratory testing, clinical research and regulatory consulting services.” According to NAMSA, Reimbursement Strategies is a consultancy “focused on reimbursement, health economics and market access for the international life science industry” which “places a significant concentration on providing clients efficacious and timely development outcomes through the organization’s expertise in reimbursement strategy, health economics, medical policy research and coverage advocacy.”

Christopher Rupp, VP of NAMSA’s global marketing and commercial operations stated that the acquisition of Reimbursement Strategies “will allow clients to proactively address the largest challenges of bringing novel devices to the global marketplace—securing appropriate coverage and payment for new and existing technologies.” Rupp continued to state that “We look forward to delivering device manufacturers faster, more cost-effective commercialization results through our comprehensive, full-service development solution.”

The former President of Reimbursement Strategies, LLC, Edward Black, stated, “We are very pleased to join the NAMSA Team as we work together to provide clients the most critical services required to navigate our industry’s complicated global reimbursement landscape.” Black, who is now NAMSA’s Director of Global Reimbursement Strategy, asserted that, “It is more important than ever for device manufacturers to assess reimbursement challenges early so they may fully integrate this planning into regulatory and clinical research pathways to achieve resource efficiencies and expedite market commercialization.”

According to Business Wire, “NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, regulatory, reimbursement, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world.” Business Wire also reports that, “NAMSA operates 13 offices throughout North America, Europe, the Middle East and Asia, and employs nearly 1,000 highly-experienced laboratory, clinical and consulting Associates.”

Garmin and ActiGraph Collaborate to Explore Health and Activity Monitoring Solutions on Wearable Devices

Garmin International, Inc. recently announced a collaboration with ActiGraph to create health and activity monitoring solutions for academic research, clinical trials, and remote patient monitoring.  The collaboration will combine Garmin wearables with ActiGraph‘s CentrePoint data analytics platform to achieve these goals.

Travis Johnson, Garmin Health global product lead, stated that “[c]ombining the sensor data from Garmin wearables with the data capture and analytical expertise of the ActiGraph platform creates a powerful solution for many different patient monitoring applications.” 

ActiGraph chief technology officer Jeremy Wyatt expressed similar praise for ActiGraph’s new partner, stating that “Garmin wearables produce high resolution, accurate data streams that are ideal for scientific analysis and can provide additional, novel endpoints to the ActiGraph software platform.”

Garmin International, Inc. is a subsidiary of Garmin Ltd.  Garmin is known for developing a variety of products, such as handheld GPS devices and wearable fitness trackers.  On the other hand, ActiGraph offers a variety of activity monitors and also software platforms to analyze data collected by such monitors.

Both Garmin and ActiGraph acknowledge the growing importance of wearable devices as potential health and medical tools.  By partnering with ActiGraph, Garmin has indicated its interest in the future development of wearable devices with medical applications.  Likewise, the partnership allows ActiGraph to utilize Garmin’s experience in developing wearable devices to apply and hone its data monitoring and management systems. 

Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic “Jervis” Patent

On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc.  The ‘141 Patent is entitled “Medical Devices Incorporating SIM Alloy Elements.”  The ‘141 Patent states that it relates to “a medical device containing a shape memory alloy element.”

The ‘141 patent discloses using stress and temperatures below body temperature to restrain a metal alloy.  The alloy expands to its original shape after being released from its restraint and exposed to body temperature.  In one example, the ‘141 Patent describes that the disclosed device enables doctors to treat damaged or diseased heart valves with a less invasive transcatheter heart valve procedure.  Figures 3 and 4 of the ‘141 Patent, shown below, illustrate a “side elevation view of a partial section of a catheter” in stressed (Figure 3) and unstressed (Figure 4) configurations.

The petition seeks to review all claims of the ‘141 Patent.  Cook Medical’s petition submits two grounds on which the claims of the ‘141 Patent should be found invalid due to obviousness.  The status of the proceeding can be examined by searching for the patent on the Patent Trial and Appeal Board website.

This is not the first time that the ‘141 patent has been subject to a petition for inter partes review.  On January 17, 2014, Edwards Lifesciences Corporation filed a petition with the Patent Trial and Appeal Board requesting inter partes review of the patent for review of all claims of the ‘141 Patent.  According to a Medtronic press release, on May 20, 2014, Medtronic and Edwards reached a “global settlement agreement” to “dismiss all of the pending litigation matters and patent office actions between them.”

In May 2013, Lombard Medical filed a petition for inter partes review of Claims 1-10 and 18-22 of the ‘141 Patent.  Lombard Medical’s products, according to its website, include the AORFIX™ endovascular stent graft.  According to a Lombard press release, on October 17, 2013, Lombard was granted a non-exclusive license by Medtronic to the ‘141 Patent, and Lombard formally requested a withdrawal of its inter partes review petition with the USPTO.

The ‘141 Patent has also been previously litigated. The ’141 Patent, among others, was previously asserted by Medtronic against W.L. Gore & Associates, Inc. in 2006; Gore’s EXCLUDER® AAA, TAG, and VIABAHN SFA® endoprosthesis devices were at issue.  The parties entered into a confidential settlement in 2009.

Medtronic also previously asserted the ’141 Patent, among others, against AGA Medical in 2007.  AGA’s AMPLATZER® Septal Occluder, Duct Occluder, and Vascular Plug devices were at issue.  The parties entered into a settlement in 2010 in which AGA received a non-exclusive license to patents including the ’141 Patent in exchange for $35 million.  AGA Medical was subsequently purchased by St. Jude Medical in October 2010 for $1 billion.

FDA Clears Mobile Medical Application for Patients with Opioid Use Disorder

On December 10, 2018, the U.S. Food and Drug Administration (FDA) announced that it granted clearance of the reSET-O™, a mobile medical application to help increase retention of patients with Opioid Use Disorder (OUD) in an outpatient treatment.

Developed under an agreement between Pear Therapeutics and Sandoz Inc., a division of Novartis, reSET-O™ is said to be the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder.  It is a mobile device application that provides a 12-week interval PDT for patients with OUD. Utilizing Community Reinforcement Approach (CRA), reSET-O™ provides a series of training, monitoring, and reminder tools and/or lessons for patients and health care providers alike.  A clinical trial sponsored by National Institute of Drug Abuse (NIDA) found statistically significant increase in patient retention in a treatment program for 12 weeks who used the reSET-O™ program.

President and CEO of Pear Therapeutics, Corey McCann, M.D., Ph.D, reiterated the importance of the FDA clearance of the reSET-O™ for treating patients with OUD.

Nearly 50,000 drug overdose deaths involving opioids . . . took placed in the U.S. in 2017. Thereis an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.

FDA Commissioner Scott Gottlieb, M.D. addressed the FDA’s continued commitment to promote the development of medical device that could help treat addiction:

As part of our efforts to address the misuse and abuse of opioids, we’re especially focused on new tools and therapies that can help more people with opioid use disorder successfully treat their addition. Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in contributing to these treatment efforts.

Sandoz, per the terms of the agreement, has already launched reSET®, Pear’s PDT for the treatment of Substance Use Disorder, in November 2018 and plans to launch reSET-O™ soon.

 

 

FDA Plans Overhaul of 510(k) Clearance Program

Recently, the U.S. Food & Drug Administration (FDA) announced plans to modernize FDA’s 510(k) clearance pathway, which was adopted more than 40 years ago.  The FDA stated that the plans are aimed at continuing to ensure that new and existing devices meet their standard for safety and effectiveness as technology rapidly advances. 

The FDA announcement reflects its focus on innovation by driving innovators toward reliance on more modern predicate devices.  Under the current framework, medical device manufacturers are required to submit a premarket notification to demonstrate that the low- to moderate-risk device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (“predicate device”) that is not subject to Premarket Approval.  According to the announcement, nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old, contrary to the Agency’s belief that newer devices should be compared to the benefits and risks of more modern technology.

The Agency announced that it is considering, in the next few months, publishing on CDRH’s website those devices that have been cleared on the basis of demonstrated substantial equivalence of predicate devices that are more than 10 years old. The Agency also said that they are developing proposals to potentially subset certain older predicates and promote the use of more modern predicates.  Following up on the announcement, FDA Commissioner Scott Gottlieb, M.D., stated,

As devices become increasingly complex, it’s important that they meet the latest standards for cybersecurity, interoperability, biocompatibility and usability engineering.  The FDA has recently advanced policies on these issues, and we know that older predicates often don’t meet our more recent expectations.

Even though the announcement lacks details on these proposals, according to the announcement, in early 2019, the FDA intends to finalize guidance establishing an alternative 510(k)  pathway that allows manufacturers of certain well understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products. 

 

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