Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Showing posts with label FDA approval. Show all posts
Showing posts with label FDA approval. Show all posts

Wednesday, July 1, 2026

FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

 

Will your competent? doctor and hospital be DOING ANYTHING WITH THIS?

Do you prefer your doctor, hospital and board of director's incompetence NOT KNOWING? OR NOT DOING? Your choice; let them be incompetent or demand action!

FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

Bioness’s PoNS system is designed to improve gait impairment in stroke patients by stimulating the trigeminal and facial cranial nerves.
Bioness Medical’s oral neuromodulation system for rehabilitating stroke patients with gait deficits has secured clearance from the US Food and Drug Administration (FDA). The California-based company’s portable neuromodulation stimulator (PoNS) system delivers neurostimulation through a mouthpiece placed on the tongue. Designed for at-home use in conjunction with physical rehabilitation, the prescription-only device stimulates branches of the trigeminal and facial cranial nerves, activating direct connections to the brainstem. This treatment approach promotes the development of new neural networks to compensate for impaired corticospinal pathways, with the aim of improving walking function in individuals following a stroke, Bioness stated. The device’s clearance for stroke rehabilitation was supported by Bioness’s three-study Stroke Registrational Program (SRP) that evaluated PoNS’ safety and efficacy in conjunction with physical rehabilitation therapy as compared to physical therapy (PT) alone over a 12-week treatment period. Bioness acquired the PoNS system product line from original developer Solana Company (formerly known as Helius Medical Technologies) in April 2026. Prior to the transaction, for which financial terms were not publicly disclosed, PoNS held an FDA indication for multiple sclerosis (MS) treatment.&mThe 159-patient SRP met its primary endpoint, with statistically significant improvements on the Functional Gait Assessment (FGA) scale. Treatment with PoNS plus PT led to an adjusted mean change in FGA of 5.37 points at week 12, versus a non-clinically meaningful change of 3.31 points in the control group. Meanwhile, 45% more subjects treated with PoNS responded to treatment on the basis of a six-point FGA increase threshold, with at least 30% more on the basis of a ≥4-point or ≥5-point improvement threshold. Bioness’ CMO, Antonella Favit-Van Pelt, commented: “The totality of data in chronic stroke survivors with gait deficits confirms the broader evidence of PoNS therapeutic effect in improving walking disability by transitioning the outcome of physical therapy alone to a clinically meaningful effect with a 45.5% increased response rate to PoNS treatment as compared to PT alone.”

Neuromodulation is having a significant impact in the healthcare space for the treatment of conditions ranging from sleep apnoea and chronic migraine to major depressive disorder (MDD). According to GlobalData analysis, the global neuromodulation device market is projected to reach a valuation of over $13bn in 2035, up from around $6.8bn in 2025.

Friday, March 20, 2026

Rhythm's Imcivree scores 'transformative' FDA approval in brain damage-related obesity

 In case your stroke caused this problem, see highlighted text.

Rhythm's Imcivree scores 'transformative' FDA approval in brain damage-related obesity

Rhythm Pharmaceuticals is switching up the tempo for its melanocortin-4 receptor (MC4R) agonist Imcivree. After its initial approval more than five years ago to treat certain patients with genetic-driven obesity, the drug is moving into a different and broader realm with an FDA nod for acquired hypothalamic obesity (HO). 

Acquired HO, for which Imcivree is the first approved treatment, represents an “expanded thinking” on the weight-regulating MC4R pathway that Rhythm’s product targets, Chief Scientific Officer Alastair Garfield, Ph.D., explained in a recent interview with Fierce. 

Until now, all of Imcivree’s approved uses have centered around specific genetic causes. HO, on the other hand, is a result of a hypothalamic injury such as a tumor or stroke that impairs the MC4R pathway and causes weight gain and insatiable hunger (hyperphagia).

Imcivree scored its first FDA approval in 2020 to treat obesity due to genetically confirmed POMC, PCSK1 or LEPR deficiencies. Then, two years later, it added monogenic obesity due to Bardet-Biedl syndrome to its label.

Moving outside of its bread-and-butter of genetic diseases is “a bit of a watershed moment” for Rhythm, Garfield said, presenting a “step-change in market potential” for the drug. 

The company estimates there’s an acquired HO patient population of about 10,000 in the U.S, a figure picked up from literature, tumor registries and claims data, Rhythm said in a press release. As part of its launch in the indication, Rhythm is placing importance on educating physicians and patients who might have the condition. Garfield anticipates the drug’s reach in the indication will be “a bit of a growth story,” but, as for a global patient spread, he thinks the company can “find these patients wherever we go looking.” 

Imcivree’s FDA approval was supported by Rhythm’s phase 3 Transcend trial, which saw a mean 18.4% improvement in body mass index (BMI) changes for Imcivree-treated patients. The mean BMI change from baseline came out to a 15.8% reduction for those taking the treatment, compared with a 2.6% BMI increase in the placebo group, according to the company. 

“This is a transformative milestone for Rhythm and reinforces our commitment to bringing meaningful therapies to patients living with rare MC4R pathway diseases,” CEO David Meeker, M.D., said in the company’s release. 

The new label specifically allows Imcivree’s use to reduce excess body weight and maintain reductions over the long term in adults and pediatric patients aged 4 years and older with acquired HO. 

In a note to clients, Leerink analysts called the nod a “significant label expansion” that bolsters the company’s leadership position in the genetic obesity space. The approval brings Rhythm to a “major inflection point,” the analysts wrote, noting that the company has “successfully transitioned from an R&D-stage biotech to a commercial-stage company with durable revenue visibility.”

Imcivree is Rhythm’s sole commercial product and garnered $194.8 million in 2025 sales.

The FDA’s blessing in acquired HO marks a welcome reprieve from a trial fail Rhythm reported earlier this week, which ended its hopes of expanding into a different subset of genetic obesities. Still, considering how “pivotal” the MC4R pathway is to defining body weight, “I think there are many more places where we’re going to learn in time our approach is going to be the most effective,” Garfield said. The executive spoke with Fierce Pharma before the latest results dropped. 

As it stands, a potential expansion into Prader-Willi syndrome is “front and center for us,” Garfield noted.  
 

Obesity lessons
 

Rhythm cracked into the obesity space in its small genetic corner before Eli Lilly and Novo Nordisk busted the market wide open with their popular GLP-1 products for general obesity. When Lilly and Novo’s drugs rose to widespread popularity a few years back, Rhythm ultimately learned a “very valuable lesson,” Garfield said.

“We were concerned we were going to be the proverbial damsel in distress,” Garfield said, painting a picture of the smaller pharma “tied to the railway tracks as these two juggernauts of Novo and Lilly came careening across us.” 

Instead, Rhythm came to find out that “a rising tide lifts all boats,” Garfield said, referring to how the GLP-1s have increased awareness and interest in obesity therapeutics. 

Of course, that increased awareness comes with further education to be done on the differences between hyperphagia and general obesity and battling the notion that all obesity is the same. But, with additional awareness and proof that the MC4R mechanism works in the “right” populations, Rhythm can “put a moat around our patient populations,” Garfield said. In the future, he expects obesity to become an "umbrella term" with well-defined subsets underneath the broader definition. 

Wednesday, March 26, 2025

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

 Be careful out there.

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The U.S. Food and Drug Administration (FDA) has announced a new recall for the ablation catheters associated with Johnson & Johnson MedTech’s Varipulse pulsed field ablation (PFA) system. No devices need to be returned or removed from the market. Instead, the FDA is urging all customers to read updated instructions provided by Johnson & Johnson MedTech. 

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack shortly after treatment. The expected stroke rate is closer to 1%(Even that is unacceptable!), the FDA explained, prompting this action. 

In total, four serious injuries have been linked to this issue.

This is a Class I recall, which means the FDA believes patients face a risk of serious injury or death if they use the devices without reviewing the updated instructions. 

These safety concerns provide additional context after Johnson & Johnson MedTech paused the U.S. rollout of its Varipulse PFA system in early January and then resumed its rollout nearly six weeks later. 

Johnson & Johnson MedTech’s recommendations for Varipulse users

Johnson & Johnson MedTech has shared a letter with all of its customers highlighting several recommendations for the use of its Varipulse PFA system going forward. Those recommendations include:

  • Review findings from the company’s investigation into the reported periprocedural strokes and adhere to the updated instructions.
  • Share this information with patients when determining if treatment with this PFA system is right for them.
  • Be aware of a planned U.S. post-approval study designed to further investigate the benefits and risks associated with this device.
  • Be aware of the known and inherent risk of neurovascular events that may occur during catheter-based ablation procedures.
  • Follow patients who received ablation procedures with the device according to their standard of care.
  • Ensure that your facility is aware of these concerns and the updated instructions.
  • Keep this information in your facility’s records. 

Click here for the full FDA advisory. 

Johnson & Johnson MedTech previously noted that these issues do not impact Varipulse cases performed outside the U.S. due to the “unique platform configuration” used to evaluate U.S. cases.

Recall follows FDA approval in 2024

Johnson & Johnson MedTech first gained FDA approval for the Varipulse PFA system in November 2024. The agency had previously approved Medtronic’s PulseSelect and Affera systems and Boston Scientific’s Farapulse system.

The FDA made its decision after reviewing data from the admIRE clinical trial, which included 277 patients who underwent treatment with the Varipulse system throughout the United States. The study linked PFA with Varipulse to acute procedural success in 100% of patients and a primary effectiveness success rate of 75%.

Thursday, March 20, 2025

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

 In case your doctor doesn't inform you of this.

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The U.S. Food and Drug Administration (FDA) has announced a new recall for the ablation catheters associated with Johnson & Johnson MedTech’s Varipulse pulsed field ablation (PFA) system. No devices need to be returned or removed from the market. Instead, the FDA is urging all customers to read updated instructions provided by Johnson & Johnson MedTech. 

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack shortly after treatment. The expected stroke rate is closer to 1%, the FDA explained, prompting this action. 

In total, four serious injuries have been linked to this issue.

This is a Class I recall, which means the FDA believes patients face a risk of serious injury or death if they use the devices without reviewing the updated instructions. 

These safety concerns provide additional context after Johnson & Johnson MedTech paused the U.S. rollout of its Varipulse PFA system in early January and then resumed its rollout nearly six weeks later. 

Johnson & Johnson MedTech’s recommendations for Varipulse users

Johnson & Johnson MedTech has shared a letter with all of its customers highlighting several recommendations for the use of its Varipulse PFA system going forward. Those recommendations include:

  • Review findings from the company’s investigation into the reported periprocedural strokes and adhere to the updated instructions.
  • Share this information with patients when determining if treatment with this PFA system is right for them.
  • Be aware of a planned U.S. post-approval study designed to further investigate the benefits and risks associated with this device.
  • Be aware of the known and inherent risk of neurovascular events that may occur during catheter-based ablation procedures.
  • Follow patients who received ablation procedures with the device according to their standard of care.
  • Ensure that your facility is aware of these concerns and the updated instructions.
  • Keep this information in your facility’s records. 

Click here for the full FDA advisory. 

Johnson & Johnson MedTech previously noted that these issues do not impact Varipulse cases performed outside the U.S. due to the “unique platform configuration” used to evaluate U.S. cases.

Recall follows FDA approval in 2024

Johnson & Johnson MedTech first gained FDA approval for the Varipulse PFA system in November 2024. The agency had previously approved Medtronic’s PulseSelect and Affera systems and Boston Scientific’s Farapulse system.

The FDA made its decision after reviewing data from the admIRE clinical trial, which included 277 patients who underwent treatment with the Varipulse system throughout the United States. The study linked PFA with Varipulse to acute procedural success in 100% of patients and a primary effectiveness success rate of 75%.

Sunday, October 20, 2024

Tenecteplase more likely to lead to 'excellent' stroke recovery, study finds

 At the very bottom, they tell you this: does not have FDA approval for this purpose, so future action may involve seeking this approval.

So your competent? doctor would have to know of this research and buck the system to use it on you as a stroke patient! Do you really think your doctor is up to that challenge?  I bet they don't even know of this research.

Tenecteplase more likely to lead to 'excellent' stroke recovery, study finds

mature woman sitting on the floor repotting plants
A new study has found that between tenecteplase and alteplase treatment, the former leads to slightly better stroke recovery. Image credit: Mihajlo Ckovric/Stocksy.
  • Ischemic strokes occur when there is blocked blood flow to the brain, something that can result in permanent disability.

  • Doctors can use certain medications to dissolve blood clots when they are the cause of blockage in an ischemic stroke.

  • A recent paper reports that the use of the drug tenecteplase may lead to slightly better functional and disability outcomes than alteplase for people who experience acute ischemic stroke.  (Slightly better IS NOT GOOD ENOUGH YOU BLITHERING IDIOTS! 100% recovery is good enough. GET THERE!) 

Strokes are a common cause of death and disability in the United States. Ischemic strokes are the most common stroke type, which have to do with the obstruction of blood flow to the brain.

Doctors are interested in what medications can best assist people who experience ischemic strokes to improve overall outcomes.

A systematic review and meta-analysis recently published in Neurology, the American Academy of Neurology’s medical journal, compared the effectiveness of two clot-dissolving medications doctors use to treat ischemic stroke: tenecteplase and alteplase.

Researchers found that tenecteplase had a higher association with excellent functional outcome and decreased disability 3 months after a stroke than alteplase.

The results of this review support increasing the use of tenecteplase in clinical practice.

Tenecteplase vs alteplase: How do they compare?

Taking action to dissolve clots can be part of ischemic stroke treatment. Alteplase has to be administered within hours of when stroke symptoms start.

The authors of the current review noted that “alteplase is the only approved systemic reperfusion treatment of acute ischemic stroke.” However, they also noted that some groups, like the European Stroke Organisation, have recommended using tenecteplase as an alternative for ischemic stroke treatment.

Researchers sought to compare the use of tenecteplase and alteplase within four and a half hours of stroke symptom onset. They also examined tenecteplase’s efficacy and safety.

This review and meta-analysis included 11 randomized controlled trials. The authors identified these trials through a systematic literature search.

From all the trials, researchers were able to examine data from 3,788 participants who received tenecteplase, and 3,757 participants who received alteplase. These participants had similar baseline characteristics, stroke symptoms, and time of treatment intervention.

The main outcome researchers looked for was excellent function outcome at 3 months after a stroke occurred.

Excellent function was described as a score of 0 to 1 on the modified Rankin Scale, which corresponds to either no symptoms post-stroke or some symptoms but no significant disability.

Researchers also looked at several secondary outcomes, like good functional outcome, which indicates a stroke recovery level range of no symptoms to slight disability.

Based on their analyses, participants who received tenecteplase were more likely to experience an excellent functional outcome compared to participants who received alteplase. Tenecteplase-treated participants also had a lower risk for disability 3 months post-stroke compared to alteplase-treated participants.

Researchers observed similar rates of good functional outcome, safety, all-cause mortality, and symptomatic intracranial hemorrhage between the treatment groups.

Are there different types of tenecteplase?

In a subgroup analysis, the researchers distinguished between two types of tenecteplase: original and biocopy.

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Based on the findings from two studies, the review authors did not find a significant difference in excellent functional outcome rates in participants who received biocopy tenecteplase and participants who received alteplase.

However, the authors noted that these two studies likely “do not have enough statistical power to demonstrate superiority.”

They further conducted a trial sequential analysis to see if they could firmly conclude teneteplase’s effectiveness. This analysis suggested that tenecteplase is effective.

José Morales, MD, a vascular neurologist and neurointerventional surgeon at Providence Saint John’s Health Center in Santa Monica, CA, who was not involved in this review, explained to Medical News Today that:

“When tenecteplase (TNK) was first released and trialed for clinical use in acute stroke, there were a lot of mixed signals. Some initial reports indicated TNK achieved better recanalization rates, had less bleeding complications, and possibly could provide a longer therapeutic window ([over] 4.5 hours). None of these have been borne out in randomized trials, but there was a clear signal of TNK’s non-inferiority both in terms of safety and efficacy compared to tPA [alteplase]. Meta analyses such as these are helpful to consolidate data and achieve the sample size necessary to draw meaningful statistical comparisons where individual trials might have fallen short.”

What are the implications for people who had a stroke?

This research suggests that tenecteplase may lead to slightly better outcomes for people who experience ischemic stroke. Thus, the study authors advocate for transitioning to tenecteplase in clinical practice.

Morales noted that: “The capacity to administer clot-busting medications is the first step for any hospital hoping to serve patients at need. The ease of use of TNK continues to be backed by valid clinical data and has implications for systems of care.”

“For instance,” he added, “since tPA administration required an infusion, this impacted timely transfer between stroke centers for escalation of care. TNK offers the advantage of not only being easier to use, but also now has growing validated clinical data supporting its safety and efficacy.”

Christopher Yi, MD, a board-certified vascular surgeon at Memorial Orange Coast Medical Center in Fountain Valley, CA, also not involved in the study, further emphasized the clinical benefits of using tenecteplase:

“The clinical implications include a shift in standard practice towards using TNK as the preferred thrombolytic agent for AIS [acute ischemic stroke] within the early 4.5-hour window. Given its ease of administration, TNK could streamline the thrombolysis process, reduce treatment times, and facilitate faster transfers between hospitals. Additionally, adopting TNK widely may improve patient outcomes and reduce healthcare costs due to its effectiveness.”

“However,” Yi cautioned, “challenges such as regulatory barriers, availability, and medicolegal considerations must be addressed to implement this transition effectively. The findings advocate for TNK’s broader implementation, potentially leading to modifications in treatment protocols and guidelines across various healthcare systems.”

Is tenecteplase approved for stroke treatment in the US?

The limitations of this review are also worth acknowledging. First, its authors pointed out, that at the time they conducted the meta-analysis, three of the trials had not had detailed study results published.

Second, the meta-analysis was a study-level analysis, which does not allow for certain actions like subgroup analyses and confounding adjustments.

There were also different types of tenecteplase under review, so more research may be required to examine the difference between original tenecteplase and biocopy tenecteplase.

Researchers were also limited by trials available for analysis, which came from a limited number of countries. Finally, all included trials had their own limitations that could have affected any of the results of the analyzed trials.

The researchers were able to identify certain concerns of the trials that could have affected the results, such as certain participants not receiving randomized treatment and one trial where they could not guarantee masking. The trial sequential analyses also made certain assumptions.

Despite these limitations, if future research continues to confirm tenecteplase’s superiority, it may become more widely used in clinical practice.

Alteplase has been a first-line treatment for ischemic stroke for decades and has approval from the Food and Drug Administration (FDA) for this purpose.

Currently, tenecteplase, while approved as a treatment for heart attacks, does not have FDA approval for this purpose, so future action may involve seeking this approval.

View the original article on Medical News Today

Wednesday, June 12, 2024

FDA approves Investigational Device Exemption for Early Feasibility Study for rehabilitation of stroke patients using CorTec’s Closed-Loop Brain Interchange implant system

I would never do this, I see nothing here that suggests they can remove the device.

Video here: CorTec Brain Interchange System - Closed Loop Brain Computer Interface

FDA approves Investigational Device Exemption for Early Feasibility Study for rehabilitation of stroke patients using CorTec’s Closed-Loop Brain Interchange implant system

CorTec has announced today that the US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application by the University of Washington School of Medicine (UW) involving the closed-loop Brain Interchange Implant System. This clinical study will investigate a novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain. With the clearance of the Brain Interchange System for human use CorTec is prepared to serve clinicians and research groups with its advanced implant technology to investigate novel treatment options for neurological diseases.

 

With the Brain Interchange System, CorTec aims to provide a fully implantable closed-loop Brain-Computer Interface (BCI) to clinicians for the investigation of therapies. According to CorTec CTO Dr. Martin Schuettler, this closed-loop functionality provides new possibilities for highly individualized treatments. He states, "The system is capable of interchanging information between biology and technology, between brain and computer. That's why we call it CorTec Brain Interchange. With our system, we are providing the technological tools that are needed to develop new therapies and brain-computer interface applications."

With FDA clearance secured, CorTec joins forces with partners in the USA to continue the development of novel therapies. The first IDE study1 involving the Brain Interchange System will be conducted in collaboration with one of the world’s leaders in the field, principle investigator professor Jeffrey G. Ojemann from the University of Washington School of Medicine in Seattle as well as Prof. Steven C. Cramer from the University of California Los Angeles and their respective teams. With funding by the US-American National Institutes of Health (NIH)2, the consortium aims at obtaining initial first-in-human safety data and at the development and evaluation of novel therapeutical rehabilitation approaches for upper limb impairment in stroke patients via direct cortical electrical stimulation delivered by the Brain Interchange System. Enrollment of patients and the first implantation of the neural interfacing system are schedule for the third quarter of 2024.

Assistant Professor Dr. Jeffrey Herron from University of Washington is a co-investigator of the NIH funded study and the engineering lead on the project. He explains the importance of the FDA approval for the upcoming IDE study: “In the United States, all studies involving devices which pose a significant risk require the approval by both the FDA and institutional review board prior to participant recruitment. The FDA review of Investigational Device Exemptions for significant risk device studies is a rigorous process involving the submission of extensive documentation by both UW, the research site, and CorTec, the device manufacturer. The FDA makes their determination for a specific study based upon the details of the study protocol, an extensive hazard analysis, and an in-depth evaluation of the manufacturer’s documents pertaining to the design and testing of the device to ensure that it will perform as needed for the study. The fact that UW and CorTec have now received this IDE approval from FDA is an absolutely critical milestone demonstrating a readiness to proceed towards participant recruitment for this study, pending local UW IRB approval.”

CorTec’s CEO, Dr. Oliver Baertl adds, “We are very excited about the feedback from the FDA! This was an important first step for CorTec to support clinical research in the fast growing neuromodulation and Brain Computer Interface space. We foresee many more studies with our device. The first in human use will be the next milestone for our technology and our company.”

______________________________________________________________________________________

Disclaimer: The research reported in this publication is supported by the National Institute Of Neurological Disorders And Stroke of the National Institutes of Health under Award Number UH3NS121565. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

______________________________________________________________________________________

References:

[1] IDE Application reference G230003/A001

[2] NIH Project 1UH3NS121565-01A1: ” Motor Recovery through Plasticity-Inducing Cortical Stimulation”, in response to RFA-NS-18-023: https://reporter.nih.gov/search/-xvTvG85Ukm-KXyunAWaJw/project-details/10357993

Wednesday, May 1, 2024

Route 92 announces US FDA 510(k) clearance for FreeClimb 54 reperfusion system

 Does your competent? stroke hospital have procedures in place to bring in new stroke interventions? NO? So you don't have a functioning stroke hospital?  You'll have to direct the ambulance to a more successful place.

Route 92 announces US FDA 510(k) clearance for FreeClimb 54 reperfusion system

Route 92 Medical has today announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the FreeClimb 54 reperfusion system, comprised of the FreeClimb 54 aspiration catheter paired with a Tenzing 5 delivery catheter.

This new system is part of a growing portfolio of neurovascular devices from Route 92, designed to work harmoniously as a complete endovascular thrombectomy solution to address a broad range of neurovascular interventions, according to a company press release.

“Route 92 Medical works to provide innovative endovascular thrombectomy solutions to clinicians, helping them maximise their opportunity to restore blood flow to the brain on their first attempt,” said Tony Chou, chief executive officer of Route 92. “The FreeClimb 54 reperfusion system is an essential addition to our product portfolio, enabling clinicians to use our products to address a wider range of patient needs.”

The FreeClimb 54 system can telescope through the company’s complementary products, allowing physicians to rapidly, predictably reach and remove stroke-causing clots during endovascular thrombectomy procedures. Route 92’s recent press release also notes that FreeClimb 54’s robust tip and shaft design facilitates use for multiple passes, and compatibility with other technologies. Additionally, the system may be used to remove distal clots when first-line therapies fail to completely remove the clot.

“The launch of the FreeClimb 54 reperfusion system continues Route 92 Medical’s progressive and complete approach to stroke care,” stated Peter Pema (Riverside Methodist Hospital, Columbus, USA). “This system combines the unparalleled effectiveness and safety of their Tenzing delivery system with an aspiration catheter that can reach far into the cerebral circulation beyond the proximal branch vessels. Thus, the size of the FreeClimb 54 system offers clear advantages to clinicians looking to achieve rapid, safe recanalisation of vessels on the first attempt.”

“The FreeClimb 54 system is a gamechanger,” added Ronald Budzik (Riverside Methodist Hospital, Columbus, USA). “It is a simple system capable of getting a larger bore aspiration catheter to distal anatomy, especially around tighter turns.”