FDA Approves Medtronic Melody TPV For Implantation in Failed Pulmonary Heart Valves

Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary heart valves. Medtronic touts the Melody TPV as providing these patients with a minimally invasive treatment option as an alternative to additional open-heart surgery.

The Melody TPV was previously approved under the FDA’s Humanitarian Device Exemption (HDE), a program for technologies that may treat fewer than 4,000 patients a year, subject to additional regulations, without meeting all of the traditional pre-market approval rules.

Commenting on the approval, Dr. Jeremy Asnes of the Yale School of Medicine said:

As the 1st commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits. Thousands of congenital patients globally have benefited from this therapy in the past decade. With this expanded indication, we can further reduce the need for obtrusive open-heart surgery and allow even more patients to benefit from this minimally invasive treatment option.

Grand View Research predicts that the global transcatheter valve market is expected to reach a worth of $8.62 billion by 2024. According to the Centers for Disease Control and Prevention, congenital heart defects are the most common birth defect in America and the top killer of infants with birth defects. An estimated 40,000 babies are born with congenital heart defects in the United States every year.

Strategic Partnership Announced between BioSig Technologies and Mayo Clinic

BioSig Technologies recently announced a ten-year strategic agreement with Mayo Clinic and Mayo Clinic Ventures. According to the press release, the agreement aims to advance clinical features of BioSig’s PURE EP System, which BioSig describes as a novel platform designed to obtain and display important clinical data during procedures that test the electrical activity of the heart, through close collaboration with leading Mayo electrophysiologists.  BioSig intends the collaboration to result in the development of future technologies.

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Speaking of the agreement, Greg Cash, President and CEO of BioSig Technologies commented:

“Adding innovation and intellectual property to the equation should raise this collaboration to a whole new level, likely resulting in better diagnosis and treatment of complex arrhythmias in many patients.”

BioSig Technologies describes itself as a Minneapolis-based medical device company developing a platform for cardiac electrophysiology.  According to Yahoo! Finance, BioSig is publically traded over-the-counter and has a current market cap of about $36 million.

Mayo Clinic describes itself as a nonprofit organization committed to clinical practice, education, and research.

The Future of “Single Use Restrictions” in Jeopardy

In 1992, the United States Court of Appeals for the Federal Circuit held that manufacturers of patented medical devices can use the patent laws to enforce single-use restrictions on medical devices.  Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992).  The basic rationale of the decision was that a patent owner, when selling a patented product, may choose to part with all or only some of its patent rights associated with that product.  If the patent owner chooses not to sell to the purchaser the right to re-use the patented product after its initial use, then that right remains with the patent owner.  Accordingly, if the purchaser, or even a downstream purchaser, re-uses the patented product, it is exercising a right that was not granted by the patent owner, and the patent owner may, in some circumstances, sue for infringement.

In the 25 years since the Federal Circuit decided Mallinckrodt, medical device manufacturers have relied on the patent laws to enforce single-use restrictions.  However, medical device manufacturers may be unable to rely on Mallinckrodt for much longer.  The Supreme Court recently agreed to consider a case, Lexmark International, Inc. v. Impression Products, Inc., which may have implications on the availability of using the patent laws to enforce single-use restrictions.

In Lexmark International, Inc. v. Impression Products, Inc., 816 F.3d 721 (Fed. Cir. 2016) (en banc), Lexmark alleged that Impression Products infringed Lexmark’s patent by selling refilled printer cartridges, which were originally sold by Lexmark to a purchaser and subject to a single-use/no-resale restriction.  A panel of 12 judges, representing the full United States Court of Appeals for the Federal Circuit, determined that a third-party who did not take part in the original conditional sale of the patented item may be held liable for infringing the patent covering the item for failing to abide by the single-use restrictions contained in the original sales agreement.

On December 2, 2016, the Supreme Court agreed to hear the appeal from the Federal Circuit.  Before hearing arguments from the parties involved, the Supreme Court allows non-litigants to submit amicus curiae (friends of the Court) briefs.  These briefs provide additional information to the Court to help it better understand the potential implications of the Court’s decision.  Reflecting the magnitude of the Supreme Court’s forthcoming decision, at least thirty-four amicus curiae briefs were filed.  Fourteen briefs were filed in full or partial support of the petitioner, Impression Products, Inc., by amicus curiae  such as: Huawei Technologies Co., Ltd.; Costco Wholesale Corporation, et al.; Intel Corp., Dell Inc., and Vizio Inc.; Association of Medical Device Reprocessors; and HTC Corporation and HTC America, Inc.  Sixteen briefs were filed in full or partial support of the respondent, Lexmark International, Inc. by amicus curiae such as: Intellectual Property Owners Association; Medtronic PLC, and Zimmer Biomet Holdings, Inc.; Qualcomm Incorporated; Pharmaceutical Research and Manufacturers of America; Dolby Laboratories, Inc.; and Nokia Technologies Oy, and Nokia USA Inc.  Copies of all amicus curiae briefs may be found here.

Due to the possibility that the Supreme Court’s decision may affect the ability of medical device manufacturers to sell patented devices subject to single-use restrictions, Knobbe Martens filed an amicus curiae brief on behalf of the Medical Device Manufacturers Association, advocating affirmance of the Federal Circuit’s Lexmark decision and retention of the legal principle announced in Mallinckrodt.  The Medical Device Manufacturers Association, in its brief, explained that single-use restrictions are consistent with existing patent laws, which permit patent owners to restrict the patent rights conveyed with the sale of a patented product, as long as the restriction does not impermissibly broaden the scope of the patent owner’s rights in violation of the antitrust laws or principles of patent misuse.  The Medical Device Manufacturers Association further explained that single-use restrictions on medical devices are designed to maximize public safety by preventing imperfectly refurbished medical devices from entering the market.

Oral argument for Lexmark International, Inc. v. Impression Products, Inc. occurred on March 21, 2017.  A transcript of the proceedings may be found here.

Certain Medical Devices Exempted from 510(k) Requirements

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements.  This publication was made by the FDA pursuant to the 21st Century Cures Act, signed into law on December 13, 2016.

Premarket notification (510(k)) is one of several alternative procedures that medical device manufacturers must undergo before being able to market their medical devices intended for human use.  The 510(k) notification is required for medical devices that do not need to receive premarket approval (PMA) from the FDA and are not exempt from the 510(k) requirement.  The FDA explains that medical devices are classified into three classes (Classes I, II, and III) based on based on the level of control necessary to assure the safety and effectiveness of the device.  Most Class I and II devices and a few Class III are subject to the 510(k) requirement.  Although a 510(k) applicant does not need to provide scientific evidence of safety and effectiveness for the intended use of its device, the applicant must demonstrate that the device is at least as safe and effective (“substantially equivalent”) to a legally marketed device (“predicate device”).

The FDA may exempt devices from 510(k) requirement.  A list of factors that the FDA use to determine whether the device is exempt from 510(k) requirements includes: (1) whether the device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) whether characteristics of the device necessary for its safe and effective performance are well established; (3) whether changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means before causing harm or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not likely to result in the device’s classification.

Section 3054 of the 21st Century Cures Act amended sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  The amended sections 510(l) and 510(m) of the FD&C Act require the FDA to publish any Class I and Class II devices that the FDA determines no longer require premarket notifications under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness.  The FDA is required to publish initial lists for Class II devices and Class I devices within 90 days and 120 days, respectively, after the enactment of the 21st Century Cures Act and then to update the lists at least once every 5 years.

A list of 510(k)-exempt Class I devices is expected to be published in about 30 days.

FDA Approval for Medtronic’s Reveal LINQ ICM with TruRhythm Detection

On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection.

Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the device in Japan during September 2016, launching the product shortly after.  Medtronic now seeks to duplicate its successful launch in the United States.

As shown on the right, the Reveal LINQ ICM is designed to be implanted just under the skin of a patient’s chest during a minimally invasive procedure.  Once implanted, the monitor can help doctors properly diagnose and treat patients having an increased risk of cardiac arrhythmias and patients who experience symptoms, such as dizziness, palpitation, fainting or syncope, and chest pain that may be related to cardiac arrhythmia.

According to Medtronic’s press release, the device “offers exclusive algorithms that result in a 95 percent reduction in false bradycardia (slow heartbeat) episodes,” a 47 percent reduction in false pause (brief absence of cardiac activity) episodes,” and “a 49 percent reduction in false detections” of atrial fibrillation (AF) when compared with its predecessor.

To achieve these reductions, Medtronic’s next generation device “features a self-learning atrial fibrillation . . . algorithm, which learns and adapts to a patient’s heart rhythm over time.”  According to Dr. James Allred of Greensboro, N.C.’s Cone Health Medical Group Heartcare, “The enhancements with the Reveal LINQ ICM with TruRhythm Detection make it smarter by streamlining device data review so physicians can make decisions more accurately and quickly for patients.”

To that end, Nina Goodheart, Vice President and General Manager of the Patient Monitoring & Diagnostics business at Medtronic, stated,

We collaborated with hundreds of clinicians and analyzed more than 50,000 ECGs allowing us to pinpoint how we could redesign our algorithms to improve detection specificity, without compromising sensitivity.

According to the press release, such collaborations have produced one of the world’s smallest cardiac monitors—the device is approximately one-third the size of a AAA battery.  Because the device is so small, is MR-conditional, and can wirelessly connect to Medtronic’s network, Medtronic’s website states that the device allows a doctor to continuously monitor a patient for up to 3 years without removing the device.

As a result, Medtronic has continued its global launch of the product.  According to Randy Lieberman, M.D., director of electrophysiology at Detroit Medical Center, the technology is going to help “reach more patients at risk for cardiac arrhythmias and help healthcare systems more efficiently manage difficult patient populations.”

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for hospital use.  The device will be available in the European Economic Area, Iceland, Liechtenstein and Norway.BODYCAP-0300

According to BodyCap, the e-Celsius® device is a disposable electronic capsule coated in a biocompatible medical grade plastic and allows for the continuous and non-invasive monitoring of a patient’s core temperature.  The pill wirelessly transmits temperature measurements to a monitor viewable by a health care professional and exits the body in about 1 to 3 days.  Sébastien Moussay, co-founder of BodyCap stated:

“The e-Celsius device is a true alternative method to the current use of rectal or eosophageal probes, which are invasive, uncomfortable, generate stress and limit the patient’s mobility.”

 “Our device is less intrusive and requires less from the medical staff, while at the same time increasing the well-being of both patients and healthcare personnel by lightening the workload. With the internal memory embedded in each capsule, e-Celsius ensures the monitoring of the patient’s temperature kinetics in real time or deferred time, whatever the measurement conditions.”

BodyCap’s website indicates that the broad medical applications of the e-Celsius® capsule ranges from general diagnostic to  monitoring of patients during surgery or chemotherapy.  Related e-Celsius® capsules have already been used outside the hospital setting, particularly in the monitoring of athletes.  The device has previously been used during athletic events including the New York Marathon and the 2016 Summer Olympics.

Persistent Market Research estimates the market for global ingestible e-pills will reach almost $1.5 billion by the end of 2024.  The e-Celsius® capsules reportedly will be sold for a unit price of $42 to $63, depending on volume, according to a MedGadget article.

Other ingestible sensors on the market include products by Proteus Digital Health.

According to public databases, BodyCap is the listed Applicant of U.S. Pat. No. 9,559,290.

Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza

Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor. The results are based on a collaborative effort between Myriad Genetics and AstraZeneca for identification and treatment of patients with metastatic breast cancer and underlying BRCA 1/2 mutations.

In 2014, the FDA approved the use of BRACAnalysis CDx to identify patient with advanced ovarian cancer that would benefit from treatment with olaparib. Jonathan Lancaster, the chief medical officer of Myriad Genetics stated that, “we believe the results of the OlympiAD trial support use of BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing.”

The recent announcement is the first report of data from a Phase 3 Clinical Trial (the OlympiAD trial) that compares treatment options in Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations. The treatments compared the responses to Lynparza and so-called physician’s choice chemotherapy, where the investigators will choose Capecitabine, Vinorelbine, or Eribulin. Mydriad’s BRACAnalysis CDx test was used to identify patients with germline BRCA 1/2 mutations and these patients showed a statistically-significant improvement of progression-free survival when treated with olaparib compared to treatment with a chemotherapy of the physician’s choice.  Information about the clinical trial can be obtained here: https://clinicaltrials.gov/ct2/show/NCT02000622.

According to Myriad, BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variations of BRCA1 and BRCA2 in both protein coding and intron/exon junctions regions of the genes. The device analyzes genomic DNA obtained from whole blood. Small genetic variations including single nucleotide polymorphisms (SNPs) are identified using PCR with Sanger sequencing. Larger genetic variations, including large deletions and duplications, are detected using multiplex PCR.

 

Obamacare Replacement Would Repeal Medical Device Tax

Republican lawmakers recently proposed a replacement of Obamacare known as the American Health Care Act (AHCA).  One provision of the proposed legislation would permanently repeal Obamacare’s 2.3% medical device excise taxBeginning in 2013, manufacturers and importers of certain medical devices were required to pay a 2.3% tax on sales of these devices.  Although the medical device tax was suspended for 2016 and 2017, it was set for reinstatement in 2018.

Introduction of the AHCA is not the first time that lawmakers and industry lobbyists have attempted to permanently repeal the medical device tax.  For example, in January 2017, a group of more than 220 Representatives introduced a bill in the House of Representatives that sought to repeal the tax.  In introducing that bill, Rep. Erik Paulsen (R-MN) released a statement citing improvements in the industry after temporarily suspending the tax:

We are already seeing new American jobs and increased investment in research and development as a result of the temporary suspension of this tax. With over 200 cosponsors at the start of this new session, and with overwhelming bipartisan support, permanent repeal should be a top priority for Congress.

Beyond repealing the medical device tax, the Washington Post reports that the AHCA seeks to repeal a wide array of taxes that were expected to cost insurance, medical device, and other healthcare companies billions of dollars over the next decade.  Indeed, according to the Joint Committee on Taxation the 2.3% medical device tax, alone, was expected to cost these companies $20 billion over the next ten years.

Medical device industry representatives are encouraged by the prospect of a full repeal of the medical device tax.  Scott Whitaker, CEO of the trade association AdvaMed stated:

Repealing the tax will provide medical technology innovators with the long-term certainty necessary to support future job growth and sustainable, cutting-edge R&D that will ultimately lead to the next generations of breakthroughs in patient care and treatment. We urge the House and Senate to act expeditiously to pass this important legislation.

Voxello Receives FDA 510(k) Clearance for the Noddle Communication Device

Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016.  According to the press release, the noddle gives patients who are unable to speak a way to communicate through voluntary gestures.  Voxello touts the noddle as allowing patient access to nurse call systems, environmental controls, communication apps, and speech generating devices with a touch or a click of the tongue.

Coralville, Iowa-based Voxello was founded in 2013 through the Iowa Medical Innovations Group (IMIG) at the University of Iowa.  IMIG is an interdisciplinary program that includes students from the Colleges of Medicine, Business, Law, and Engineering.  The noddle student team consisted of Vince Hahn, Zihan Zhu, Blake Martinson, and Ben Berkowitz, with Richard Hurtig serving as professor mentor.

Commenting on the 510(k) clearance, Voxello CEO Rives Bird said:

At Voxello, our mission is to provide an effective and universal means to overcome communication barriers faced by hospitalized and long-term care patients. Today 3.9 million hospitalized patients each year are unable to communicate through traditional means, which results in an estimated three billion dollars in preventable adverse events. The FDA clearance of the noddle brings us one step closer to offering a solution for this urgent, unmet need.

The following video is provided on Voxello’s website:

Matthew A. Howard, Chair and DEO, Dept. of Neurology, University of Iowa Healthcare System, commented on his experience with the device:

The technology incorporated in the Voxello noddle has been extremely helpful in enabling us to provide the best possible care for neurosurgery patients with severe neurological injuries.

Additionally, Voxello recently closed a Series A round of financing: on February 20, 2017, the Kansas City-based Mid-America Angels investment group announced that it invested $287,000 into Voxello.

 

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2 billion in 2016, and is projected to continue to grow. The medical device industry is outsourcing not only the manufacturing of medical devices, but also associated services, such as regulatory consulting and contract manufacturing, to medical device service providers. Medical device manufacturers and outsourced medical device service providers should be conscious of the regulatory and legal ramifications of the delocalization associated with the outsourcing that is increasingly common in today’s global market.

While outsourcing has traditionally been linked to manufacturing, outsourcing of services has become a major growth engine in the medical device industry. Outsourced services include regulatory consulting, product design and development, testing and sterilization, implementation, upgrades, maintenance, and manufacturing contracts. Regulatory consulting, which in 2015 already commanded over 50% of the outsourcing market for services, is particularly expected to grow. Regulatory consulting includes services directed to compliance with national agencies that approve and continually monitor the safety of medical devices, including the F.D.A. in the United States and the E.F.S.A. in Europe. In addition, contract manufacturing is reported to be the fasted growing service in the medical device industry and is projected to grow at a compound annual growth rate of over 11.5% through 2025.

There are several benefits associated with medical device outsourcing. According to an MDDI article, outsourcing can help original equipment manufacturers (OEMs) accelerate time to market for a new product, and speed up return on investment. Furthermore, the article states outsourcing can provide specialized knowledge, expertise, and facilities without the significant resources required to acquire such expertise in house. Moreover, outsourcing can leverage the pre-existing large supply chain of the contractor.

However, outsourcing also carries potential risks. The issues associated with outsourcing so many aspects of services uniquely associated with the medical device industry may not be as well known or well understood as the issues presented by outsourcing manufacturing. According to another MDDI article, these issues may include an increased risk of civil lawsuits from consumers of medical devices. This is especially true as medical devices become increasingly digital, and cybersecurity vulnerabilities are found. The medical device industry may also face increased regulatory scrutiny from national agencies as more regulatory compliance is outsourced to consulting services. Consequently, the medical device industry and medical device legal community will increasingly face new challenges from a world in which more and more industry services are outsourced.

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