BioCardia submits bid for FDA clearance of Avance transseptal introducer

BioCardia

BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of steerable introducers and applies the same technology for transseptal procedures.

BioCardia touted that the Avance introducer is intended to be virtually whipless around curves due to helically arranged pull-wires, and added that the system also offers a rotating hemostasis port.

“The best-in-class design that underlies Avance was developed to enhance delivery of our investigational CardiAMP and CardiALLO cell therapies. We are excited about making this product available to the broader transseptal market, and expect it to favorably impact revenues in the second half of 2019,” BioCardia CEO Peter Altman said in a press release.

In August, BioCardia touted data from the first 10 patients treated in its Phase III CardiAmp heart failure trial.

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NuVasive wins expanded FDA nod for Monolith corpectomy system

NuVasive

NuVasive (NSDQ:NUVA) said yesterday that it won expanded FDA 510(k) clearance for its Monolith corpectomy system, now cleared for use in cervical corpectomy procedures.

The system is now cleared for procedures in the cervical spine, between the C3-C7 vertebral bodies, to treat diseased or damaged vertebral body caused by fractures, tumors, osteomyelitis or to support reconstruction following corpectomy for the decompression of the spinal cord and neural tissue in cervical degenerative disorders, the San Diego-based company said.

The device was initially cleared in 2015 for use in thoracolumbar corpectomy procedures, NuVasive said. The system features a monolithic cage made from PEEK and modular endcaps for anatomical personalization.

“Expanding the indicated use of our Monolith corpectomy system to include cervical corpectomy procedures demonstrates the company’s continued commitment to expanding our cervical spine interbody portfolio. We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives,” strategy, tech & corp dev prez Matt Link said in a press release.

Last month, NuVasive said that it won FDA 510(k) clearance for Cohere porous PEEK implants that are part of its Extreme Lateral Interbody Fusion surgical spinal procedures.

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Subtle Medical wins FDA nod, CE Mark for SubtlePet AI-powered imaging system

Subtle Medical

Medical imaging tech developer Subtle Medical said today that it won both CE Mark approval in the European Union and FDA 510(k) clearance for its SubtlePET artificial-intelligence-powered positron emission topography imaging enhancement system.

The SubtlePET system is designed to enhance images and reduce scanning times to improve overall patient experience during imaging procedures, the Menlo Park, Calif.-based company said.

“Focusing Subtle Medical’s SubtlePET AI platform on faster image acquisition, we have been able to dramatically increase PET scan efficiency and provide a superior patient experience. SubtlePET technology allows us to scan a patient four times faster than normal, yet maintain equal image quality, not otherwise impacting work flow. This creates immediate ROI benefit for our hospital and a compelling value proposition.  I’m looking forward to seeing more groundbreaking technology from the Subtle team,” Dr. Michael Brant-Zawadzki of Newport Beach, Calif.-based Hoag Hospital said in a prepared statement.

Subtle Medical said that the system is currently in pilot clinical use in multiple university hospitals and imaging centers in the US and internationally, the company said.

The company added that it is developing additional products it will seek FDA clearance for, including the SubtleMR for MRI scanning uses and the SubtleGAD for gadolinium dosage during imaging procedures.

“This FDA clearance is a key milestone in Subtle Medical’s mission to bring novel and empathetic deep learning to improve patient satisfaction. The accomplishment of having the first AI cleared for use in nuclear medicine applications validates our team’s strength and the commitment of our collaborators.  Our focus on image acquisition and workflow differentiates us from other AI companies that are working on post-processing and computer-aided diagnosis products.  We are not replacing radiologists–we are addressing the tremendous cost to U.S. healthcare by leveraging deep learning in imaging at the infrastructure level to enable better and higher quality care,” founder & CEO Enhao Gong said in a press release.

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Edwards wins FDA nod for next-gen HemoSphere platform

Edwards Lifesciences

Edwards Lifesciences (NYSE:EW) said yesterday that it won FDA 510(k) clearance for its Hemosphere platform with the Acumen suite of decision-support solutions intended for hemodynamic monitoring.

The Irvine, Calif.-based company touted that the newly cleared HemoSphere platform is the first to include predictive monitoring for moderate to high-risk surgical patients.

The system now includes the Acumen hypotension prediction index, a machine-learning powered algorithm intended to indicate the likelihood of a hypotensive event, and the Acumen IQ sensor, which allows the HPI software to update parameters every 20 seconds, Edwards said.

“Combining the Swan-Ganz catheter and the FloTrac sensor with the Acumen suite and the hypotension prediction index software on the HemoSphere platform presents a powerful integration of hemodynamic information. The common interface simplifies the workplace for clinicians while providing comprehensive guidance to optimize and individualize patient care,” Edwards consultant Dr. Neal Fleming of the UC Davis School of Medicine said in a prepared statement.

“With the addition of the Acumen suite, the HemoSphere platform is a cornerstone solution that integrates a range of advanced hemodynamic monitoring solutions and decision-support tools to address patient needs in a range of clinical settings. Moving forward, Edwards plans to continue to evolve and expand the machine learning algorithms to ensure clinical relevance in surgical and intensive care unit settings, to truly establish HemoSphere as the platform of the future,” Edwards critical care corp VP Katie Szyman said in a press release.

This week, Edwards Lifesciences launched a pivotal tiral of its Pascal mitral valve repair system, touting that th first procedure was performed this week at Atlantic Health System’s Morristown Medical Center.

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Merit Medical wins FDA nod for EmboCube embolization gelatin

Merit Medical received FDA 510(k) clearance for its EmboCube embolization gelatin.

EmboCube is used in the embolization of hypervascular tumors. It features uniformly cut cubes of gelatin foam that have been designed to address preparation concerns and inconsistent particle sizes that come with traditional gelatin foam sheets as an embolic. Embocube gets preloaded into a Medallion syringe to deliver the gelatin smoothly and with minimal to no resistance.

Get the full story on our sister site, Medical Design & Outsourcing.

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ElectroCore wins cluster headache FDA 510(k) indication for GammaCore

ElectroCore Logo

ElectroCore said today that it won expanded FDA 510(k) clearance for its GammaCore non-invasive vagus nerve stimulation therapy, now cleared for adjunctive use for the preventive treatment of cluster headaches in adult patients.

The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve.

The expanded approval was supported by results from two studies which demonstrated the safety and efficacy of the system in preventing the treatment of cluster headaches, ElectroCore said, including data from its pivotal Preva study and a real-world retrospective study.

Results from the Preva study indicated that patients who received the standard of care and treatment and treatment with the GammaCore had a greater reduction in the number of cluster attacks per week from baseline than those who only received the standard of care. Patients treated with the GammaCore device experienced a total of 3.9 fewer attacks per week, ElectroCore said.

Data also indicated that 40% of patients who received GammaCore treatment alongside the standard of care had a 50% or greater reduction in weekly cluster attacks, versus only 8.3% of patients who received the standard of care, ElectroCore said. Investigators also noted a 57% decrease in the frequency of abortive medication for GammaCore patients.

The incidence of adverse events was noted as similar between both treatment and control cohorts, with most reported adverse events noted as mild or transient. The most common adverse events reported in the GammaCore group were headache, dizziness and neck pain at 8%, 8% and 6%, respectively. No serious adverse events were considered device-related, the company said.

“The FDA clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition often referred to as a ‘suicide headache. We are pleased that cluster headache patients now have a FDA-cleared option, and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments,” CEO Frank Amato said in a press release.

In August, ElectroCore said that it inked a collaborative research deal with Massachusetts General Hospital exploring the use of ElectroCore’s non-invasive vagus nerve stimulation tech in targeted treatments for neuroinflammation.

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Amsel Medical wins FDA nod for Endo Occluder

Amsel Medical

Amsel Medical said today that it won FDA 510(k) clearance for its Amsel Endo Occluder device intended for occluding blood vessels during endoscopic procedures.

The Cambridge, Mass.-based company touted that the clearance is the third the company has received from the FDA so far for its portfolio of occluder devices.

The Amsel Endo Occluder is a mechanical occlusion clip delivered through a fine needle intended to be deployed to transfix a target vessel while clamping it shut. The device is composed of an endoscopic litigating clip applier and clips which the company said are intended or use on tubular structures or vessels.

“We are thrilled to expand the Amsel Occluder family of single-use, site-specific vascular control devices into the endoscopic and minimally invasive surgery market with this recent Pre-Marketing Notification (510(k)) by the US Food and Drug Administration. The Amsel Occluder possesses the ability to transfix and ligate a selected vessel or duct. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder device is cleared for commercial distribution,” founder & prez Dr. Arnold Miller said in a press release.

Last November, Amsel Medical touted the first-in-human clinical use of its Amsel AOD2 occluder device, which took place at the NYU Langone Medical Center in New York.

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FDA: Updated predicate devices will improve safety, efficacy in 510(k) clearances

FDA

The FDA yesterday released a notice explaining why it believes a push for modernizing predicate devices used in equivalence testing within the 510(k) clearance pathway will improve overall safety and effectiveness.

The plan to move towards newer predicate devices is part of the federal watchdog’s larger plans to “modernize” its 510(k) pathway and make itself the gold standard regulatory body globally, which it released details on earlier this month.

In a posting released today, FDA head Dr. Scott Gottlieb said that older predicate devices may not “reflect the newest performance standards” or the agency’s most recent understanding of the benefits and risks of such devices.

“We want to create policy vehicles that will move the market towards reliance on newer predicates that reflect more modern characteristics related to their safety and performance,” Dr. Gottlieb wrote in the release.

As announced earlier this week, those policies include making information about devices cleared based on substantial equivalence to systems 10 years or older available to the public. The federal watchdog said that it will be seeking public feedback on whether 10 year old devices “are the right starting point” and if there are other actions it could take to encourage the use of modern predicates.

Between 2015 and 2018, approximately 20% of 510(k)s cleared by the FDA were based on substantial equivalence to predicates that were more than 10 years old, Gottlieb wrote in the release.

“We don’t think these devices are unsafe—they met our standards for reasonable assurance of safety and effectiveness—but we are concerned that this practice of relying on predicates that are old, and may not reflect modern performance characteristics, means that some devices are not continually improving. Yet beneficial iteration is at the heart of health technology advancements that can truly benefit patients,” Dr. Gottlieb said.

As complexity increases and interconnectivity among devices becomes more important, so to does testing devices that incorporate the latest protections against cybersecurity threats, the FDA said. Other devices, such as those that use radiofrequency technology or laser technology, “may not meet the newer consensus standards adopted by the FDA,” the federal watchdog wrote.

The agency said that it will work to identify device types where “there are clear benefits to relying on more modern technology to demonstrate substantial equivalence and obtain FDA clearance of a 510(k).”

“We want to push product developers to embrace newer predicates with improvements in technology so that patients and providers will continually have access to safer and more effective devices. At the same time that we pursue efforts to sunset older predicates, we are advancing new policies to make it more efficient to develop new predicates that reflect modern principles of safety and performance,” Dr. Gottlieb wrote in the release.

The FDA said that it will continue to update on efforts to improve its functionality.

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FDA releases 510(k) modernization plans

FDA

The FDA today released plans for updating its 510(k) clearance pathway, including a push to move away from using predicate devices over 10 years old and the creation of a new alternative 510(k) pathway that will allow approval based on objective safety and performance criteria.

In an official posting, FDA head Dr. Scott Gottliebb and FDA Center for Devices and Radiological Health head Dr. Jeff Shuren laid out plans the agency has for “modernizing” its 510(k) clearance pathway.

The release builds upon a strategy the federal watchdog laid out last week intended to improve overall post-market medical device oversight and to make the FDA “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”

In their update, the FDA heads said they “believe firmly in the merits of the 510(k) process,” but that they believe the system must be modernized to “reflect advances in technology, safety and the capabilities of a new generation of medical devices.”

“The 510(k) pathway represents a more contemporary approach to the risk-based regulation of medical products, but this doesn’t mean the pathway is perfect or not in need of change,” FDA heads Gottlieb and Shuren wrote in the release.

The first major change announced for the regulatory pathway is promoting the use of modern predicates for approvals to be based upon, according to the release.

“Nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old,” FDA heads wrote in the posting.

The FDA went on to say that it is considering making devices that demonstrated substantial equivalence based on older predicate devices public on the CDRH website, focusing on those based on devices 10 years or older.

“Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances,” FDA heads wrote.

The agency clarified that it doesn’t believe devices more than 10 years old are unsafe, or that such devices would need to be removed from the market, but that it is looking to encourage developers to use more modern predicates. Such a push, the agency hopes, will improve competition to adopt modern features and increase selection choice between old and newer devices while improving overall standards and improving outcomes.

Other efforts include a potential “sunset” to older predicates to promote the use of more modern devices for comparison, the FDA said in its release.

Moving away from issues with older predicate devices, the FDA said that, beginning next year, it intends to finalize guidelines which would create an alternative 510(k) pathway that would allow producers of well-known device types to demonstrate substantial equivalence through objective safety and performance criteria, saying that they “believe this approach is the future of the 510(k) program.”

“Rather than looking to the past as a baseline for safety and effectiveness – and rely on predicate devices that are sometimes decades old as our point of comparison – our premarket review would be based on a contemporary baseline that looks to the future and a baseline that can be updated as technologies advance,” FDA heads wrote.

Through the new route, dubbed the “Safety and Performance Based Pathway,” a company would only have to demonstrate that their device meets performance-based criteria that the FDA has set to achieve approval, according to the release. The criteria would be based upon the safety and performance of modern predicate devices, the agency added.

The pathway would be a “direct and transparent approach” to demonstrating the safety and effectiveness of low to moderate risk devices, the federal watchdog said.

“This alternative pathway to substantial equivalence would provide more direct evidence of the safety and performance of a device and better information for patients and providers to make well-informed health care decisions. In addition, with this new approach, the FDA may drive greater market competition to develop safer devices. Manufacturers would be able to demonstrate that their products meet or exceed objective safety and performance criteria that are based on modern technological principles. And companies could also, for the purposes of supporting coverage decisions, more readily demonstrate to payors that their products perform better than other devices on the market,” the FDA heads wrote.

In addition to its new plans, the FDA also released a performance report touting its improvements to the 510(k) program, including an increase in page size and a decrease in overall average time to decision.

“We recognize that our approach as regulators must continue to evolve, to anticipate and meet the challenges and opportunities of the coming decades. We must look ahead. We not only have to skate to where the puck will be, we also need to drive the puck to where it should be,” the FDA wrote in its release.

As a result of the modernized 510(k) plans, the agency said it expects that it will receive more interest in the de novo pathway, and said that it will be releasing a proposed rule “clarifying procedures and requirements for submissions of de novo requests.”

The agency said it will also continue to release updates on its progress and the status of its Medical Device Safety Action Plan.

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SIG Medical wins FDA nod for Advantage Rib fracture repair device

SIG Medical

SIG Medical said this week it won FDA 510(k) clearance for its AdvantageRib anterior system, a rib fracture system.

The newly cleared AdvantageRib anterior system includes anatomically contoured titanium plates intended to closely fit patient anatomy and screws, and is intended to be used through a traditional anterior approach. The system also features straight plates to allow the surgeon to create a construct to fit challenging clinical scenarios.

“We are thrilled to have achieved this approval and now have the most comprehensive portfolio of rib fracture products. The AdvantageRib family of products is truly revolutionary and will change how suffering patients are treated.  Surgeons now have choices as to how best to treat their patients, in both a traditional manner or with our novel system that is on the forefront of improving how rib fractures are managed.  Today is a huge leap for us and the medical community as a whole,” product dev & marketing VP Andrew Davison said in prepared remarks.

Screws included with the system include self-drilling, self-tapping, locking and non-locking screws in a range of different sizes to fit varying anatomy, SIG Medical said.

“We have a world class team, working capital, and now the most complete line of products to lead the market in fixing fractured ribs. The AdvantageRib family of products will have a significant impact on the algorithm of care for decades to come and I am proud to be part of such an exciting movement,” prez & CEO Ken Kremer said in a press release.

The device is the second rib fracture system that the Hershey, Penn.-based company is commercializing, according to a press release.

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