Showing all posts written by Albert Sueiras
During law school, Mr. Sueiras externed at the United States Patent and Trademark Office within Art Unit 3733, focusing on patent examination of orthopedic surgical instrumentation. Mr. Sueiras also participated in a patent prosecution externship at Banyan Biomarkers, Inc. in Alachua, Florida, a firm specializing in the discovery of biomarkers for traumatic brain injury and neurotoxicity.
Mr. Sueiras worked as a summer associate at the firm in 2015 and joined the firm in 2016. Click here to read full bio
The United States Department of Justice announced that medical device company Affordable Healthcare Solutions, LLC has pleaded guilty to charges related to unapproved prescription hyaluronic acid medical devices, as reported by a press release dated September 28, 2021. The devices are “intended for the treatment of pain in osteoarthritis of the knee that must be injected by a doctor or other qualified health care professional.” The company was sentenced for “Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to Defraud or Mislead, in violation of 21 U.S.C. §§ 331(c) and 333(a)(2).”
21 U.S.C. § 331(c) prohibits “[t]he receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.” According to the facts admitted during the plea, special agents with the United States Food and Drug Administration (FDA) located and seized foreign-market Supartz, Euflexxa, Synvisc, Synvisc-One, and Orthovisc that were adulterated for lacking FDA approval for distribution and use in the United States.
According to the press release, a review of the devices seized from Affordable Healthcare Care Solutions confirmed various differences between the outer box and carton labels, patient information brochures, and instructions for use between the FDA-approved labeling for Supartz, Orthovisc, Synvisc, Synvisc-One, and Euflexxa versus the labeling included with the unapproved versions being distributed by Affordable Healthcare Solutions. While discussing the seizure, Special Agent in Charge, Justin C. Fielder, emphasized that the “FDA regulates the manufacturing and distribution of medical devices to help ensure the safety of American patients.”
As a result of the plea agreement, Affordable Healthcare Solutions pleaded guilty to a felony, was fined, and was ordered to forfeit $837,000 worth of devices seized by the special agents. Juan Antonio Gonzalez, Acting United States Attorney for the Southern District of Florida, announced the felony guilty plea and stated:
Medical device suppliers whose greed leads them to disregard FDA protocols and approval processes put the public in danger. . . . These are serious crimes and, in our district, companies that put profit over patient safety will be held accountable.
The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities.”
The agreement formalizes a long-standing relationship by developing a new framework for greater coordination and cooperation. As part of the new framework, specific responsibilities have been assigned to the FDA and the National Protection and Programs Directorate (NPPD), a component of the DHS. The following table provides a breakdown of the responsibilities outlined in the agreement:
|FDA Responsibilities||NPPD Responsibilities|
|1. Coordinate and participate in regular, ad hoc, and emergency coordination calls to enhance mutual awareness of vulnerabilities and threats||1. Serve as central medical device vulnerability coordination center|
|2. Provide NPPD with draft public releases to facilitate coordination of messaging||2. Participate in regular, ad hoc, and emergency coordination calls with FDA to enhance mutual awareness of vulnerabilities and threats|
|3. Comment in a timely manner on NPPD draft advisories and alerts||3. Confer with entities providing sensitive information prior to sharing any CCI, trade secret, or PCII-protected vulnerability or product information with the FDA|
|4. Assess the risk to health and patient harm when potential impact is disputed||4. Coordinate with FDA on the content of alerts and advisories to be published by DHS|
|5. Submit requests to NPPD for independent third-party technical assistance to analyze and test medical systems||5. Maintain technical capabilities to support requests for independent third-party analysis regarding the impact of vulnerabilities|
|6. Share non-trade secret information to resolve disputes of risk, impacts, and communication||6. Publish healthcare and public health related alerts and advisories|
In summary, the DHS will serve as the central coordination center and interface with appropriate stakeholders, and the FDA will provide technical and clinical expertise regarding medical devices.
FDA Commissioner Scott Gottlieb, M.D., during his discussion of the new agreement, addressed the FDA’s continued commitment to confront cybersecurity risk, while also recognizing the need for increased coordination between government agencies:
The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns . . . But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important.
This agreement is not the first time a government agency has reached out to the FDA in an effort to strengthen medical device cybersecurity. As previously reported on the KnobbeMedical blog, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General recommended earlier this year that the FDA include cybersecurity review as a greater part of the premarket review process for medical devices (e.g., through the inclusion of a Refuse-To-Accept checklists). This new FDA-DHS agreement is another example of continuing attempts to address ongoing medical device cybersecurity risks.
Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.
Globus Medical, which describes itself as a musculoskeletal implant manufacturer, acquired the robotics developer Excelsius Surgical and its robotic guidance device Excelsius GPSTM three years ago according to press releases. The Excelsius GPSTM platform is said to function as a robot-assisted surgery guidance system “designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement,” according to the press release. Globus Medical further describes the platform as being compatible for use with pre-operative CT, intra-operative CT, and fluoroscopic imaging modalities.
The FDA’s decision is stated to allow the platform for use within minimally invasive and open orthopedic and neurosurgical procedures, including screw placement applications in spine and orthopedic surgery. This announcement also follows Globus Medical’s earlier news release announcing that the Excelsius GBSTM system received CE mark approval in the European Union.
Norbert Johnson, Vice President of Robotics, Imaging, & Navigation at Globus Medical, views these results as an example of Globus Medical’s developmental capabilities:
We believe the Excelsius GPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.
The Excelsius GPSTM received FDA 510(k) clearance after Globus Medical re-filed its 510(k) bid following an FDA decision that Globus Medical’s initial bid had not “sufficiently addressed the FDA’s questions,” according to Mass Device.
According to the press release, Abbott produces the Confirm RxTM ICM, which is marketed as the slimmest ICM available. Pictured on the right, Abbott states that the Confirm RxTM is designed to continuously monitor a patient’s heart rhythm and proactively transmit information via the myMerlinTM mobile app, thereby allowing physicians to follow their patients remotely and accurately diagnose arrhythmias. As noted on the Confirm RxTM webpage, the ICM is placed by a physician under local anesthesia by making a small incision in the pectoral region, inserting the ICM under the skin using an insertion tool, and then closing the incision. “Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator,” said Georg Nölker, M.D. in prepared remarks. Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark approval.
According to Abbott, the myMerlinTM mobile app makes it easy for patients to stay connected to their physicians. A listing of the product features from the Confirm RxTM product website includes:
- Transmit nightly data reports automatically simply by being in range of the smartphone;
- Manually record patient symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate;
- Confirm patient data was transmitted to their physician;
- Automatic alerts when they have missed a scheduled transmission;
- Offers secure transmission of patient data.
Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses, views these results as a step forward in ICM technology, stating:
Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance…The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.
Dr. Christopher Piorkowski, said to be one of the first physicians to implant the Confirm RxTM ICM, stated:
The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF.
As reported by the press release, the Confirm RxTM ICM is available in select European countries, with full European release expected during the second quarter of 2017. It further states that the device is currently under review by the U.S. Food and Drug Administration.
Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples of each type of pacemaker, both produced by Medtronic, are shown to the left). Medtronic states that the device provides select patients suffering from bradycardia with a minimally invasive treatment approach.
The Micra TPS, which is comparable in size to a large vitamin (as seen to the right), attaches to the heart with small tines and delivers electrical impulses that pace the heart. Thanks to its size and wireless technology, the Micra TPS does not require
leads under the patient’s skin. As such, the Micra TPS eliminates potential sources of complications that may be associated with more traditional pacemakers. Artist’s renderings comparing the Micra TPS and a traditional pacemaker when implanted are shown below.
Following what Medtronic describes as “the largest and longest clinical evaluation of leadless pacing patients to date,” the company released several statistics from its Micra TPS Global Clinical Trial that highlight the device’s long-term successes, including:
- 96% freedom-from-complication rate
- When compared to traditional pacemaker systems, the risk of
- major complications was reduced by 48% across all patient subgroups including age, gender and comorbidity
- hospitalization was lowered by 47%, and
- revision procedures was 82% lower
- The battery is projected to last an average of 12 years, based on data from 644 patients who have had the device for at least 12 months.
Regarding these results, John Liddicoat, M.D., senior vice president at Medtronic, stated:
The Micra TPS continues to deliver safe and effective pacing, while also providing a less invasive alternative to conventional pacemakers . . . . The Micra TPS has also shown a significant reduction in healthcare utilization compared to conventional pacemakers, which is promising for clinicians looking to adopt cost-effective therapies to improve patient outcomes.
These statistics follow preliminary results published in the New England Journal of Medicine in November 2015, showing that the Micra TPS was successfully implanted in 99.2% of patients. Medtronic interprets the studies as demonstrating consistent and sustained results from early performance through 12-month follow-up.
Dr. John Hummel, a cardiologist who participated in the clinical trials, explains his view that Medtronic’s wireless pacing technology is the future of pacemaker therapy.
We are looking at the beginning of the future . . . . We will no longer pace the heart in the way we have in the last 20 to 30 years. This is fundamentally a paradigm shift in how we’ll deliver this therapy.
The Micra TPS was awarded its CE Mark in April 2015. Additionally, the device was approved by the FDA for use in the United States in April 2016. The device is presently the only leadless pacemaker approved for use in both the United States and Europe.
A new blog post by The Food and Drug Administration (FDA) published earlier this month provides an update regarding the implementation of the year-old Expedited Access Pathway (EAP) program, which was created in April 2015 by the FDA’s Center for Devices and Radiological Health (CDRH).
The EAP’s goal is to help new breakthrough technologies undergo pre-market evaluation more quickly than traditional regulatory pathways, as previously reported on the KnobbeMedical blog. While the products in the EAP program are still required to undergo the costly and time-consuming premarket approval processes, this voluntary program potentially provides more options to patients afflicted with life-threatening or irreversibly debilitating diseases.
According to the recent update, the FDA has granted EAP designation to 17 of 29 requests made for the program, and decisions were typically made within 30 days. Once a device has been accepted into the EAP, the FDA “maintains a high level of interaction with sponsors and provides advice on efficient device development.”
The accepted requests have encompassed a spectrum of technologies including devices relating to the heart, brain, or kidneys. Additionally, the device manufacturers involved in the program have included both small start-up companies and large corporations.
In the past year, the FDA has also observed particular entities that may especially benefit from the EAP:
As the program has grown the past year, we’ve learned that companies who benefit most from this program are those that have a preliminary proof of principle for how their device works, but haven’t undertaken formal studies to support future submissions to FDA. For these companies, discussing their Data Development Plan with the FDA and agreeing on a roadmap to their marketing application and beyond is an important part of a successful review.
During these reviews, the FDA has stated that they carefully balance the potential risks and benefits of the new device against the risks of delaying a new therapy to patients. A decision may then be made by the FDA to accept more initial uncertainty for devices in the EAP program so that important technology can reach patients sooner. Once that device is on the market, the FDA and the program participant continue to collect additional data to address any potential uncertainty regarding the device’s safety and effectiveness.
As the EAP enters its second year, its successes will continue to be evaluated.