Six Innovative IVL Companies File IPO Prospectuses Amid Global Expansion of Intravascular Lithotripsy Technologies

Dec 25, 2024 22:15 CST Updated 22:15

Johnson & Johnson

Medical Device R&D and Manufacturer

Intravascular Lithotripsy with Shock Waves(Intravascular Lithotripsy: IVL) is a new technology for treating vascular calcified lesions. Since Johnson & Johnson (Shockwave Medical) pioneered Intravascular Lithotripsy (IVL), IVL has become one of the best options for pre-treating coronary artery calcified lesions and peripheral artery calcified lesions.

The working principle of Intravascular Lithotripsy (IVL) is different from traditional calcified lesion treatment technologies (such as expansion, cutting, and rotational atherectomy of calcified lesions). It mainly provides unfocused, circumferential, and pulsed mechanical energy to the local coronary artery lesion area, delivering mechanical pulses to both superficial and deep calcified lesions in the vascular wall. This causes the calcified lesions to break and improves vascular compliance, facilitating the smooth completion of interventional procedures such as stent placement.

As IVL technology is being accepted by clinicians, it has also reached a peak in development. Besides Johnson & Johnson (Shockwave Medical), dozens of medical device companies both in China and internationally are developing various types of IVL products. Some of these companies directly copy.Johnson & Johnson products, while some bypass Johnson & Johnson's patent barriers through innovation.DirectCopy's products quickly reached the market, even breaking records.Johnson & Johnson has a monopoly in certain countries. However, due to the lack of IP, these companies' products can only be sold in countries with weak intellectual property protection, and their products are rarely seen in Europe and America. To sell in Europe and America, IP must be taken seriously.

The following have their own IPIVL Technology Company:

[01] Johnson & Johnson

In April this year, Johnson & Johnson acquired Shockwave Medical for $13.1 billion, thereby gaining the full suite of Shockwave IVL technology.

In November this year, Johnson & Johnson publicly disclosed a new type ofIVL Catheter---Javelin.JAvelin Breaks Traditional Design of Shockwave Catheters — Balloon Catheter, Using a Balloon-Free Design,AndThe shock wave generator is set at the farthest end of the catheter, thereby achievingTransmit shock waves to the front of the catheter, and use shock waves to open the occluded blood vessel.

JavelinThe catheter includes a flushing lumen, a guidewire lumen, a pressurization lumen, and a shock wave generator.

The pressurized chamber can be filled with saline to achieve the desired treatment pressure.
Flushing the catheter lumen allows for flushing the treatment area with saline.
The guidewire lumen is used for passing through aA 0.014" (0.36 mm) guidewire to facilitate passage through occluded vascular segments under guidewire guidance.

According to Johnson & JohnsonA Javelin catheter can deliver12 rounds of shock waves, with 10 shocks per round, totaling 120 shocks.

Javelin This Unique DesignPlan, expected to solveCardiology FieldOne of the tough "fortresses" to conquer is CTO. As the creator of IVL technology, Johnson & Johnson continues to lead.IVLTechnological Development.

【02】FastWave Medical

FastWave Medical was founded in 2021, and Grand Pharmaceutical is its important...Investor. They have developed a highly deliverable IVL catheter that provides sustained 360-degree sonic output---FastWave IVL。In the past three years, it has obtained six IVL patents.

It completed a $19 million financing this month to accelerate the clinical research of its IVL platform. In addition to completing the financing this year, it also...First Clinical Data of FastWave IVL Released, Showing Feasibility and Safety of FastWave IVL.

Specific Data

Surgical outcomes included 100% procedural success, 0% perioperative adverse events, and a mean residual diameter stenosis of 5.9% post-treatment.
On Day 30, zero major adverse events, 100% patency, 0% revascularization, and systolic peak velocity ratio < 2.4.
The patient's walking distance, speed, and ability to climb stairs have all improved. The ankle-brachial index (ABI) increased from a baseline of 0.56 to 0.89 at 30 days, with an increase in blood flow.

FastWave IVL Innovation Embodiment

Excellent Delivery and Tracking

Due to traditionalShockwave BalloonBiggerCumbersome", with poor performance in delivery and tracking。For this reasonFastWave IVLThe balloon is designed with a small profile.、Optimize the shaft for better traceability and a design resistant to rupture to enhance product delivery performance.

Ergonomics

With hands-free energy delivery and an improved generator user interface providing real-time procedural feedback, intravascular lithotripsy has become easier. FastWave IVL eliminates the need for bulky connectors.And distributor.

Higher Predictability

FastWave IVL adopts a novel and durable energy generator, designed to provide greater availability of energy pulses and more consistent sound output.

【03】Amplitude Vascular Systems（AVS）

AVS Develops IVL Balloon Catheter --- Pulse IVL is a Pulsed Intravascular LithotripsyBalloon, which crushes vascular calcium through pressure waves generated inside the balloon to relieve vascular blockages caused by severe calcium accumulation and restore blood flow.

Pulse Adoption of IVLA unique mechanism of action that delivers high-frequency pulsatile pressure waves into a non-compliant balloon, rather than an emitter on the catheter, to disrupt arterial calcium. ThusPulse IVL canImprove the overall delivery performance of the catheter through a lower profile design.

AVS is one of the faster-progressing companies among overseas IVL firms. It received FDA approval for an IDE study (peripheral) in June and completed the enrollment of its first patient in October. This IDE study (POWER PAD 2) will recruit 120 patients across 20 centers and is expected to be completed by mid-2025.

【04】Bolt Medical

Bolt Medical Develops a Laser-Based IVL Balloon Catheter---Bolt IVL, thereby achievingConsistent sonic output offers advantages over the already marketed IVL platform. MeanwhileBolt IVL has a smaller profile, therebyImproved delivery performance, offering strong pushability and trackability.

Bolt IVL is an innovative shockwave balloon product designed to disrupt the intima and deep calcium by generating acoustic pressure waves within the balloon catheter. It offers increased treatment availability, a highly deliverable catheter, and visible directional emitters to provide consistent energy for treating concentric and eccentric vascular calcified lesions.

Bolt IVL & ShDifferent from Ockwave IVL, it adopts laser-based IVL technology. The laser energy is distributed through optical fibers to multiple positions within the balloon, and then through the balloon.The plasma generated internally is converted into a shock wave, thereby achievingEffect of Intravascular Lithotripsy.

Principle of Shock Waves in Laser Products

Bolt IVL Two Clinical Studies (ESTORE ATK and RESTORE BTK), the research data will serve as crucial evidence for FDA and CE approval for market release.

【05】Philips

Philips last monthThis marks the unveiling of its IVL catheter—a shockwave catheter integrated with laser ablation functionality. This shockwave catheter is highly distinctive, featuring...The biggest feature is thatLaser Atherectomy andCombined use of intravascular lithotripsy. Combined use does not simply mean using these two devices one after the other, but ratherLaser and shock wave are integrated on a single catheter, enabling simultaneous laser resection and shock wave lithotripsy.

The innovative fusion of two technologies in shockwave catheters not only simplifies surgical procedures but also reduces surgical risks and improves patient outcomes.

CurrentlyPhilips has initiated the IDE clinical trial in the United States.Study (THOR IDE), this study will enroll 155 patients (peripheral artery disease patients) across 30 centers in the United States.

【06】Abbott

Last year, Abbott acquired Cardiovascular Systems (CSI) for $890 million, gaining access to CSI's highly regardedIn addition to the rotational atherectomy technology, CSI's IVL technology under research was also acquired.

Abbott (CSI) completed feasibility testing in 2022. By the end of 2022CSI indicates that it willClinical testing was planned to begin in 2023 (following the acquisition by Abbott, no further updates on the project's progress were disclosed). At that time, CSI stated that its IVL technology aimed to enable physicians to deliver treatment more easily for more challenging atherosclerotic lesions and would also complement its broader portfolio of vascular preparation technologies.

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