According to the FDA 510(k) database, Boston Scientific's vascular shockwave balloon---Bolt IVLApproved by the FDA for marketing. This approvalBolt IVLApplicable toTreatment of stenotic lesions above the knee.

Market Evaluation

"Bolt IVL's rapid approval through 510(k) is surprising. It is reported that the system's indication for below-the-knee lesions is still under FDA review, and it is currently being evaluated for its application in treating severe coronary artery calcified lesions through the FRACTURE IDE study."

---BTIG

Boston Scientific has now become the hottest giant in the entire medical device field, completely overshadowing Medtronic and Johnson & Johnson, and is even beginning to challenge for the top position in the device industry. In the currently fastest-growing niche areas, Boston Scientific's presence can always be seen, such as in PFA, IVL, RDN, and more. Moreover...Boston Scientific takes on these innovative tracks with surprisingly high costs.Low, for example$295 Million AcquisitionFarapulse、$540 Million AcquisitionSoniVie、$6.64 Billion AcquisitionBolt Medical. Look at its competitor Johnson & Johnson's $13.1 billion acquisition of ShockWave, Medtronic$925 Million AcquisitionAffera, Medtronic $800 Million AcquisitionArdian (2010). A simple comparison shows that Boston Scientific is spending money wisely, while other companies are overpaying. This demonstrates Boston Scientific's sharp insight.

Boston Scientific was able to purchase these companies at a low price mainly because it had invested in them early on and obtained the right of first/exclusive acquisition. Some of these companies were even incubated by Boston Scientific itself, with its own funding and technology, such asBolt Medical。

To get back to the point, withBolt IVLThe approval also breaks Johnson & Johnson's monopoly in the United States. IVL has officially entered an era of fierce competition, with Boston Scientific, Abbott, Philips, and others eyeing Johnson & Johnson hungrily. Given any opportunity, these companies are eager to overthrow Johnson & Johnson. Among all competitors, Boston Scientific undoubtedly exerts the most pressure on Johnson & Johnson, not only...It was the second to be launched, and its product technologyUniqueness (IVL Technology Based on Laser).

CurrentlyBolt IVLFor below-the-kneeThe treatment is already under review, and the FDA approved the initiation of the FRACTURE IDE study for coronary use in December last year. If all goes well, the FDA may approve it this year.Bolt IVLIndications below the knee, and coronary indications are expected to be approved within the next three years.

Bolt IVL

Bolt IVLIt is an innovative shockwave balloon product designed to disrupt the intima and deep calcium by generating acoustic pressure waves within the balloon catheter. It will also feature enhanced available treatments, a highly deliverable catheter, and visible directional emitters to provide consistent energy for treating concentric and eccentric cardiovascular calcified lesions.

Bolt IVLUnlike Shockwave IVL, which uses 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 In Vitro Demonstration