On November 24, 2021, EBR Systems went public in the Australian stock exchange. According to the press release, the IPO raised AU$110M (around $78.5M). EBR pland to use these funds to complete its pivotal study, targeting FDA submission for approval in 2023 followed by rapid U.S. commercial launch.
Image Credit: Medtronic
People often ask me as a device engineer what kind of pacemaker would I get if I needed one. They are usually surprised when I tell them that it would be a traditional can with thick transvenous leads.
I feel vindicated by the letter that FDA sent to healthcare providers on November 17, which states:
“The overall risk of cardiac perforation associated with leadless pacemaker implantation appears similar to the risk associated with traditional transvenous pacing systems. However, the Medtronic Micra leadless pacemaker premarket clinical studies suggested major complications related to cardiac perforation appeared to be more severe for patients who received a leadless pacing system compared to patients who received a transvenous pacemaker. The FDA continues to evaluate outcomes in patients who receive leadless pacing systems. Information from real-world use suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers.”
Image Credit: Respicardia
FDA has approved Respicardia’s remedē® EL-X System to treat moderate to severe Central Sleep Apnea (CSA) in adult patients. The device combines enhanced functionality with a patient-friendly design, simplifying the implant procedure and providing greater device longevity for patients with Central Sleep Apnea. According to Respicardia, features of the new device include:
Image credit: MicroTransponder
FDA approved today the MicroTransponder Vivistim Paired VNS System, a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation (VNS).
Boston Scientific has recalled approximately 48,000 Ingenio pacemakers and cardiac resynchronization devices distributed between November 2011 and August 2020. The potentially defective devices, which were manufactured only through December 2018, are no longer available for implant. The recall was initiated on June 3, 2021, and now FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing. There have been no reports of death.
The issue is that after several years of use, the batteries reach a high level of internal impedance. At that point, a sudden decrease in battery voltage may occur during telemetry, incorrectly triggering a system reset. If the system resets three times within 48 hours, it’s sent into safety mode. However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device goes into safety mode, the device cannot be reprogrammed and must be replaced.
According to FDA, the use of affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life threatening injury (for example, need of temporary pacing where a healthcare provider delivers controlled electric pulses to pace a heart), worsening of heart failure and death.
Image Credit: Parandromics
The scene has been hot for brain-computer interfacing (BCI) since Elon Musk announced its Neuralink project. One of Neuralink’s competitors is Austin-based Paradromics Inc., founded in 2015, about a year ahead of Neuralink. Bloomberg reported that Parandromics recently raised $20M to continue developing its high data rate implantable BCI.
Parandromics announced back in January 2020 that it had developed an implantable, low-power, high data rate neural sensor to enable massively parallel neural recordings for next-generation therapeutic applications. From the press release:
Image Credit: Nalu
Nalu Medical, Inc. is a privately held, early-stage start-up based in Carlsbad, California. They developed the Nalu micro-Implantable Pulse Generator (mIPG), which was was named the Implant and Tissue-Replacement device Gold Winner at the 2021 Medical Design Excellence Awards (MDEA).
The Nalu system consists of a fully-featured, battery-free, miniaturized IPG, which is powered by an externally worn Therapy Disc and controlled through a smartphone based remote control app. The Nalu Neurostimulation System is currently FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications.
Nalu’s website is at: nalumed.com
Image Credit: Neuspera Medical
Neuspera Medical is a startup company located in San Jose, CA. They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.
In December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE. Neuspera now announced that they closed a $65M series C equity financing round to fund their trial on the use of their device in patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder. The Series C round was co-led by Vertex Ventures HC and Treo Ventures.
Neuspera’s website: http://neuspera.com
Image Source: Nevro’s Website
FDA has approved an additional indication of Nevro’s Senza® System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN). According to the announcement, “this approval is specific to Nevro’s unique 10 kHz stimulation, and Nevro now has the only spinal cord stimulation system approved by the FDA with a specific indication to treat PDN. The company will immediately initiate commercial launch activities in the U.S. under its recently launched HFX™ branding, as HFX™ for PDN.”
Nevro also announced its Q1 2021 revenue to be around $102.3 million, an increase of 81% compared to $56.4 million in the prior year period and an increase of 9% compared to $93.6 million in the second quarter of 2019. Nevro expects Q2 2021 revenue to be $85.0 million, an increase of 67% compared to $51.0 million in the prior year period and an increase of 9% compared to $78.1 in the second quarter of 2019.
INBRAIN Neuroelectronics S.L. was funded in Barcelona, Spain in 2019 as a spin-off from Graphene Flagship partners, the Catalan Institute of Nanoscience and Nanotechnology (ICN2) and ICREA. Its subsidiary INNERVIA Bioelectronics is working towards the development and commercialization of graphene-based systems to modulate vagus nerve signals.
INBRAIN announced that it will be collaborating with Merck to co-develop the next generation of graphene bioelectronic vagus nerve therapies targeting severe chronic diseases in Merck’s therapeutic areas.
INBRAIN’s website is at: www.inbrain-neuroelectronics.com
In October 2016, St. Jude Medical (now Abbott) issued an advisory on a family of ICD and CRT-D devices that may develop Lithium deposits within the battery leading to a short circuit and result in premature and potentially rapid battery depletion. However, according to the DOJ, St. Jude was already aware of the issue by 2013. In 2014 St Jude asked the FDA to approve an update to the devices to mitigate the battery issue. In its request, St. Jude claimed that the issue had not caused any serious injuries or deaths, but the DOJ claimed that the company had been informed of two injuries and one death caused by the issue.
The lawsuit covers the period between November 2014 and October 2016, during which the DOJ claims St. Jude was fully aware of the device’s issues but continued selling thousands of devices. By August 2016, St. Jude reported to FDA two more deaths linked to this issue, and over 700 cases of premature battery depletion.
The federal case was brought under the False Claims Act based on the allegation that by continuing to sell the potentially harmful products to healthcare facilities and implanted in patients enrolled in Medicare and Medicaid, St. Jude played a role in securing government payments for devices that they knew were defective. It was announced on July 8, 2021 that St. Jude Medical agreed to pay $27 million to settle this case.
Image Credit: CVRx
Back in August of 2019, Minneapolis-based CVRx received a no-panel FDA approval for its BAROSTIM NEO™ device to treat Heart Failure. CVRx has now filed documents with the SEC with plans to offer 6.25 million shares of common stock priced between $15 and $17 per share, expecting to yield approximately $91.5 million in the offering.
The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors. The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.
CVRx’s system is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.
CVRx website: www.cvrx.com
UPDATE: June 30, 2021, 2:49 pm
Yesterday CVRx upsized its IPO of 7M shares of its common stock at a public offering price of $18 per share. Trading started today and share price was $27 mid-afternoon.
UPDATE: July 9, 2021, 2:09 pm
A week after IPO CVRx’s stock has lost all of its initial gains. It is now trading around the original offering price of $18.
Update December 13, 2021
And CVRx stock keeps on tanking…
Medtronic announced that it will stop the distribution and sale of HeartWare’s HVAD™ System.
According to the announcement:
“Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.
In addition, Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.”
The device has been the subject of multiple Class I recalls because of reports of 91 injuries and 15 deaths. FDA advised healthcare providers to stop new implants of the HeartWare system, stating that Medtronic has “received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was necessary.”
FDA has advised providers to use Abbott’s HeartMate 3 Left Ventricular Assist System as an alternative.
In the late 1960s and early 1970s, Czechoslovakia, like many other countries, had its own pacemaker development/manufacturing.
Starting in 1965, Dr. Bohumil Peleška and ing. Vladimír Bičík designed and manufactured a VOO pacemaker under the auspices of the “Research Institute for Medical Electronics and Modelling” (RIMEM). The device underwent human implantation and worked for 2 years before being preemptively replaced.
RIMEM’s pacemakers were then transferred for commercial production at the Czechoslovak TESLA state-owned electrotechnical conglomerate. TESLA was originally named after Nikola Tesla, but later explained by the Communist regime as an abbreviation from TEchnika SLAboproudá, which means “low-voltage technology.”
An interesting presentation about the history of pacemakers in the former Czechoslovakia is available here.
Image Credit: Bivacor
Houston-based Bivacor, which was founded in 2008, has raised a total of $22M through a $19M series B funding round (co-led by Cormorant Asset Management and OneVentures) and a $3M NIH small-business grant from the National Heart, Lung and Blood Institute. This money will be used to continue testing Bivacor’s Total Artificial Heart and expand the company’s workforce, as it prepares to begin its first human trials.
The device is unique in that it features a single moving part. Two centrifugal impellers placed on a single rotor provide perfusion to the left and right sides of the body. According to the company, active magnetic levitation provides precise, stable operation with no mechanical wear, while the device’s patented left-right flow-balancing system allows dynamic adaptation to changes in the patient’s physiology.
The centrifugal pump is powered by an external battery and controller connected via a transcutaneous cable. According to Bivacor, the device is small enough for a child but also powerful enough for a physically active adult.
Bivacor website: www.bivacor.com