Medtronic vs. ReCor: RDN Patent Battle Reignites as Both Secure FDA Approval

Recently, the U.S. Court of Appeals overturned a ruling by the United States Patent and Trademark Office (USPTO), reigniting the dispute between Recor Medical and Medtronic.

Medtronic - Symplicity Spyral

Symplicity SpyralThe system includes a Spyral multi-electrode renal denervation catheter and a G3™ renal denervation radiofrequency generator.

Delivery of radiofrequency energy to the overactive nerves of the renal artery is achieved through a 360° circumferential ablation using a radiofrequency ablation catheter.

Recor Medical -Paradise uRDN

The Paradise ultrasound ablation catheter can deliver 360° ultrasonic energy generated by the balloon to the tissue surrounding the artery, producing heat for ablation within seconds.

At the same time, to avoid inner vascular damage during surgery, the Paradise balloon uses circulating cold water to cool the blood vessels.

This legal tug-of-war revolves around U.S. Patent No. 8845629 (hereinafter referred to as the '629 patent'), with Recor Medical appealing the final decision of the inter partes review (IPR).

This patent relates to methods and apparatus for achieving renal neuromodulation through thermal heating and/or cooling mechanisms. Specifically, the core concept involves using a catheter to apply thermal energy to targeted nerve fibers in order to complete renal neuromodulation.Although various forms of thermal energy can be used for neuromodulation, the patent claims focus on ultrasound technology.

Recor argued in its claim that combining renal denervation methods with ultrasound catheters constitutes an "obvious" technical solution. However, the U.S. Patent Trial and Appeal Board (PTAB) determined thatRecor failed to provide sufficient evidence to prove the obviousness of its disputed patent claims.

Recor argued in its appeal that the PTAB made a legal error: it neither considered the teaching of ablation methods using ultrasound nor correctly determined that "attempting to use ultrasound to ablate renal nerves is not obvious." Medtronic, on the other hand, contended that,Ultrasound catheters are not one of the limited predictable solutions for renal nerve modulation.

ReCor's appeal was ultimately upheld, overturning a ruling by the U.S. Patent and Trademark Office (USPTO) and remanding the case for reconsideration.This move has reignited the patent dispute between Recor and Medtronic, and it remains to be seen who will win this intellectual property war.

However,Notably, as one of the earliest players in the RDN field, Medtronic has faced multiple setbacks in this area.

According to the first comprehensive analysis report on the global prevalence trend of hypertension published in The Lancet in 2021,The Number of Adults Aged 30-79 with Hypertension Worldwide Has Reached 1.28 Billion。

Moreover, hypertension has become a severe threat to people's health. Studies show that more than 8.5 million deaths worldwide each year are directly related to hypertension, which is the leading cause of cardiovascular and cerebrovascular diseases. For patients, managing hypertension is urgently needed.

According to Fortune magazine, the international antihypertensive market will continue to grow at an average annual growth rate of 7.5% during the period from 2018 to 2023.The market size in 2023 will reach up to 5.09 billion US dollars.

The most common way for patients to treat hypertension is by taking antihypertensive drugs to control blood pressure. However, a large amount of research data shows that,Only about 50% of patients fully adhere to their prescribed medications within a year, while 20% of patients do not take any medication at all., there is an urgent clinical need for new approaches that can replace drug treatment for hypertension.

Increased chronic renal sympathetic nerve activity is an important mechanism in the development of primary hypertension, and RDN technology can reduce renal and systemic sympathetic nerve activity by disrupting renal afferent and efferent nerves.Not only can it achieve a round-the-clock blood pressure lowering effect, but it also has low surgical invasiveness, high patient acceptance, and low surgical difficulty, making it highly conducive to clinical promotion., is one of the most effective alternatives to drug therapy.

Moreover, the treatment effectiveness of RDN technology for hypertensive patients has been successively featured in several authoritative academic guidelines.

According to Jason Fontana, Vice President of Global Coronary and Renal Denervation Marketing & Strategy at Medtronic, based on the lack of response to medications across various regions around the world,The number of hypertensive patients who should or are taking medication,Medtronic Predicts Renal Denervation Could Be a "Multi-Billion-Dollar Market"。

There is no doubt that the market and clinical value charm emitted by the RDN track are worth Medtronic's continuous efforts.

The golden track that has not been fully met will inevitably attract a group of profit-seeking competitors.