Juyi MedTech Review: Major Global Medical Device Innovations in November 2024

Nov 29, 2024 14:01 CST Updated 14:01

AtriCure

Developer and Manufacturer of Surgical Ablation Devices

Axonics

Developer of Novel Implantable Neuromodulation Technologies

Medtronic

Medical Device Manufacturer

Cardiac Tissue Ablation

AtriCure, a leader in atrial fibrillation treatment, recently announced that its EnCompass cardiac tissue ablation clamp has received the EU CE mark, indicating that the device can be sold in more than 30 countries within the European Economic Area (EEA).The EnCompass Clamp has received FDA 510(k) approval in the United States and was launched in 2022.This fixture is used for full epicardial ablation of the left atrium in open-heart surgery, simplifying the surgical process and allowing doctors to complete the operation within minutes.

Surgeons in Europe have already utilized this device to complete the first batch of case treatments. AtriCure estimates that approximately 400,000 cardiac surgeries performed annually in the EU present a significant market potential for the EnCompass clamp. Additionally, the company’s technologies, such as the Isolator® Synergy™ ablation system and the globally top-selling AtriClip® left atrial appendage occlusion system, have gained widespread recognition from doctors worldwide. The EnCompass clamp stands out for its features including streamlined surgical procedures and the integration of Synergy radiofrequency (RF) technology, which incorporates parallel closure, uniform pressure, and customized power, showcasing its technological innovation.

New Implantable Neuromodulation Technology

Boston Scientific Corporation recently completed the acquisition of Axonics, Inc.Axonics Focuses on Novel Implantable Neuromodulation Technologies, Achieving Significant Results Particularly in Sacral Neuromodulation (SNM) Therapy.In the United States, overactive bladder (OAB) and fecal incontinence affect a large number of adults, significantly impacting patients' quality of life, mental health, and daily activities.Axonics Launches the First Long-Life, Compact, and Full-Body MRI-Compatible Rechargeable SNM System, Addressing Battery Life and MRI Compatibility Issues in SNM Therapy, Setting a New Milestone for the Entire Field.

Axonics' product portfolio includes the Axonics R20™ and Axonics F15™ systems, which improve symptoms such as overactive bladder by sending gentle electrical pulses to the sacral nerves to regulate bladder nerve reflexes. Among them, the Axonics R20™ is a fourth-generation rechargeable SNM system that has received FDA approval. This system consists of four components: a pulse generator, a rechargeable battery, a remote control, and a wireless charger. It features a proprietary titanium ceramic casing, is compact in size (only 5cc), provides constant current stimulation, and includes a fast and safe charging function, with each charge taking only one hour.

Drug-Coated Coronary Balloon

Medtronic Announces FDA IDE Approval for Next-Gen Coronary Drug-Coated Balloon Prevail DCB, to Initiate Pivotal Clinical Trial for In-Stent Restenosis (ISR) and De Novo Small Vessel DiseasePrevail DCB received CE approval in 2021 and has been launched in 79 countries worldwide.Medtronic Plans to Use Global Clinical Data to Support Regulatory Approvals for This Product in Japan and the United States.

The drug-loading technology of Prevail DCB is similar to Medtronic's marketed In.Pact Admin but offers stronger pushability. The In.PACT™ Admiral™ XL Drug Coated Balloon was also approved for marketing in China by the National Medical Products Administration (NMPA) in May 2024. Boston Scientific's Agent DCB received FDA approval in May this year, becoming the first coronary DCB in the U.S. for the treatment of ISR and serving as the control group in this IDE trial.

Although Prevail DCB lags behind Agent DCB in terms of registration and commercialization, if clinical data shows superior efficacy, it will facilitate Medtronic's commercial promotion of the product.

Age-related Macular Degeneration

LumiThera recently announced that its Valeda Light Delivery System received FDA approval in the United States for the treatment of patients with dry age-related macular degeneration (AMD).This system uses photobiomodulation (PBM) technology and is the world's first device authorized by the FDA to treat vision loss in dry AMD.Valeda has obtained the CE mark in the European Union and has been launched in some Latin American countries.

Dry AMD is one of the leading causes of vision loss in the elderly, with the global number of patients expected to reach 288 million. Previously, there were no effective treatments for dry AMD, with management primarily relying on lifestyle and dietary therapies. Valeda's PBM technology uses light-emitting diodes of targeted wavelengths to stimulate retinal cell growth and proliferation with low-level light, thereby improving vision. In clinical trials, Valeda has improved best-corrected visual acuity by more than five letters within 24 months.

PBM is a minimally invasive, safe, and non-invasive treatment method that has been studied for the treatment of various diseases. Valeda uses three different wavelengths of light to stimulate cellular function, enhance metabolism, and activate cell regeneration. Among them, the 590nm wavelength is used to reduce vascular endothelial growth factor and cell deposition, the 660nm wavelength enhances oxygen binding of cytochrome C oxidase and has anti-inflammatory effects, and the 850nm wavelength stimulates metabolic activity and reduces cell death.

PBM promotes cell proliferation and cell protection by targeting photoreceptors in tissues to absorb photons, generating secondary cellular effects such as increased energy production and altered signaling patterns. Valeda's PBM technology enhances mitochondrial membrane potential by activating components of the mitochondrial respiratory chain, particularly cytochrome C oxidase, thereby promoting ATP synthesis and improving vision in patients with dry AMD. This innovative therapy offers a new treatment option for patients with dry AMD, demonstrating significant market potential and growth trends.

Ophthalmic Microsurgery Suturing Needle

In November, Corza Medical, a leader in the global medical technology field, officially launched its newly developed Onatec ophthalmic microsurgery suture needle at the 2024 American Academy of Ophthalmology (AAO) annual meeting.This suture needle is meticulously designed to optimize surgical outcomes and ensure patient safety.

Onatec Suture Needles are meticulously crafted by Corza Medical using high-quality, high-tempered stainless steel. This material endows the suture needles with excellent resistance to bending and outstanding durability, which is undoubtedly of paramount importance for the precise operations required in ophthalmic microsurgery.

It is worth mentioning that Corza Medical, formerly known as Surgical Specialties Corporation in the United States, has continued to grow and expand since its name change in May 2021. The company now covers multiple product lines including ophthalmology, wound closure, and hemostasis. Within the ophthalmology division, Corza Medical offers numerous trusted brand products such as Sharpoint™ surgical blades, Stylus™ surgical blades, UniqueEdge™ surgical blades, Sharpoint™ sutures, and UltraPlug™ punctal plugs. Among these, the Sharpoint surgical blade stands out as a leader in the field of ophthalmic surgical blades, thanks to its 52 years of profound research and manufacturing expertise.

Spinal Cord Stimulation Technology

Ottobock recently announced a significant investment in Onward Medical, a developer of spinal cord stimulation technology, becoming the latter's largest shareholder.This investment not only provides financial support to Onward Medical but, more importantly, establishes a strategic partnership between the two parties.

Onward Medical is a medical technology company dedicated to developing innovative spinal cord stimulation therapies aimed at helping patients with spinal cord injuries regain movement, function, and independence. The company's ARC Therapy™ platform, including the non-invasive ARC-EX® and the implantable ARC-IM® systems, offers new treatment options for patients with spinal cord injuries.

Among them, ARC-EX® is a non-invasive treatment device that improves arm and hand function in patients with spinal cord injuries by placing electrodes on the skin's surface to deliver electrical stimulation to specific nerve areas. This method does not require surgery, offering patients a more convenient and safer treatment option.

Urodynamic Testing Technology

On November 1, Bright Uro announced the successful completion of its second tranche of Series A financing, with the round being oversubscribed by 40%.The funds will help the company further expand in the medical field.Lower Urinary Tract Symptoms (LUTS) are a complex set of problems involving urination, which may arise from various factors such as benign prostatic hyperplasia (BPH), overactive bladder (OAB), underactive bladder, bladder stones, urethral stricture, and more.

To address this challenge, Glean has introduced an innovative wireless, catheter-free urodynamic testing technology. This technology, through its four core components—sensors, delivery system, App software, and uroflowmeter—provides clinicians with more accurate data and actionable insights, aiming to completely revolutionize the urodynamic evaluation process. Among these, the sensor's medical silicone-coated pressure transducer is a standout feature, capable of wirelessly transmitting bladder pressure data, allowing patients to move freely and urinate normally during the test, significantly enhancing the convenience and comfort of the procedure.

Minimally Invasive Prostate Treatment

On November 19, Zenflow announced the successful completion of its Series C financing. The funds will be used to support the pre-market approval (PMA) and commercialization readiness of its Spring® system.

The Spring® System is a minimally invasive treatment solution specifically designed for patients with benign prostatic hyperplasia. It uses a spring-like stent made of nickel-titanium alloy to gently support the urethra through a minimally invasive approach, restoring its normal function while preserving the natural anatomical structure. The system offers significant advantages in reducing trauma, alleviating pain, and accelerating recovery.

Specifically, the minimally invasive surgical incision of the Spring® system is small, causing less damage to the surrounding tissues, which helps reduce postoperative bleeding. Due to the minimal trauma, postoperative pain is usually lighter than traditional surgery, allowing patients to resume normal activities more quickly. The recovery time for minimally invasive surgery is typically shorter, enabling patients to return to daily life and work faster. Additionally, the materials used in this system possess superelasticity and memory properties, which can return to their preset shape at body temperature, providing better adaptability and stability, reducing the risk of postoperative complications. Compared with traditional surgery, the Spring® system is also reversible, allowing the implant to be easily removed or repositioned, offering patients more options and flexibility.。

Portable Home Dialysis Machine

Recently, Quanta Dialysis Technologies, a UK-based developer of hemodialysis systems, successfully completed its Series E funding round, raising over $60 million. The funds will primarily be used for the commercialization of its portable home dialysis machine, Quanta, as well as for new technology research and development.

On November 4, the Quanta Dialysis System received 510(k) clearance from the U.S. FDA for use in home settings. Quanta is the first system capable of providing a high dialysate flow rate (500 mL/min) for end-stage renal disease (ESRD) patients, covering the entire care continuum.

The Quanta dialysis machine is designed with simplicity and intuitiveness, requiring a short setup time and only 4.5 hours of optimized training, making it more accessible for patients to use. Its proprietary dialysate cassette eliminates the need for chemical disinfection, reducing the complexity of equipment maintenance and operation. The QDS water trolley incorporates an integrated water pre-filtration system, combined with the Mar Cor 300 H reverse osmosis system, allowing for rapid deployment and use wherever there is a water supply. The modular design enables the system to be quickly adapted across different medical facilities, weighing only 71 pounds, which facilitates easy movement and transportation by medical staff.

In addition, the Quanta dialysis machine is equipped with a built-in water treatment system and can be connected to a cloud-based digital health platform for remote monitoring of equipment status to ensure optimal performance. The system offers dialysate flow rates as high as 500 ml/min and as low as 300 ml/min, meeting the needs of different patients. As of November 21, 2024, Quanta is the first and only device to receive FDA approval for performing Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED), and Continuous Renal Replacement Therapy (CRRT).

Surgical Robot

News on November 21, 2024: Medtronic acquires joint manufacturer Fortimedix Surgical.This acquisition will further expand Medtronic's business scope and may leverage Fortimedix Surgical's technology to enhance the functionality of its surgical robot products.

Fortimedix Surgical has developed proprietary articulated instrument technology, which is considered to "challenge conventional methods." Based on a fully laser-cut product architecture, this technology can be applied to endoscopic therapeutic interventions and minimally invasive surgeries, and enables early surgical intervention through endoscopy, namely endoluminal surgery.

Fortimedix Surgical utilizes multi-layer laser-cut tubing nested and welded together, enabling products to achieve complex functionalities and superior performance while transforming ordinary low-cost metal tubes into flexible articulating shafts. These shafts, when assembled, consist of hundreds of moving parts, delivering complex functions while maintaining cost-effectiveness.

Source: Siyu Medtech, China Biotechnology Network, The Paper, CCI Cardiovascular Doctors Innovation Club, Device Home, Bone Future, etc.

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