Sirolimus Coated Balloon: A Stepping Stone in Future Treatment of PVD (Sponsored)

Prof. Ulf Teichgräber (Germany) shares his views on the MagicTouch PTA Sirolimus Coated Balloon (Concept Medical) for the treatment of peripheral arterial disease. He is excited about the first-ever use of the MagicTouch PTA Sirolimus Coated Balloon in a live case from his center, Jena University Hospital, at LINC 2020, and describes how the balloon successfully navigated and performed well during the procedure. His colleague performed a challenging case in order to treat two areas in the femoral popliteal artery and the MagicTouch PTA Sirolimus Coated Balloon performed well. Prof. Teichgräber speaks about how the medical device industry has avoided use of a sirolimus coated balloon in the peripheral arteries, limiting use to the drug paclitaxel, and describes paclitaxel’s safety concerns.

Prof. Teichgräber is a senior author of a meta-analysis published in November 2019 in E-Clinical Medicine, a subchannel of the Lancet, that reviewed the safety and risk of paclitaxel. The meta-analysis showed that 1 out of 17 patients treated with a paclitaxel drug coated balloon had a risk of mortality 24 months post procedure. He notes that this meta-analysis showed similar results to what Dr. Katsanos had already stated in his comprehensive meta-analysis; namely, that the safety profile is not in favor of paclitaxel.

Prof. Teichgräber has participated in numerous trials and has also been principal investigator for studies regarding the safety and efficacy of paclitaxel. While it has been well established that paclitaxel is effective, he believes the safety concerns are alarming and there has long been a need for an alternative option. The limitations of using paclitaxel in drug coated balloon treatment in peripheral arterial disease, considering the risk factor of the drug, have been a concern for many interventionalists.

Prof. Teichgräber is excited to see Concept Medical’s development of a drug coated balloon with sirolimus for the treatment of peripheral arterial disease. The company has overcome the obstacles of coating a balloon surface with the highly hydrophilic sirolimus by efficient use of nanotechnology. Sirolimus has a well proven safety and efficacy profile in the coronary arteries, with 45,000 patients already treated. Prof. Teichgräber believes the MagicTouch PTA Sirolimus Coated Balloon is an excellent alternative. Peripheral interventionalists have long been obligated to use only paclitaxel for drug coated balloon treatment. The MagicTouch PTA Sirolimus Coated Balloon is the answer to a safe and efficient DCB. It is truly a next-generation alternative in the treatment of the PVD and Prof. Teichgräber found its use in a live case encouraging.

Having a technology which is able to deliver the highly hydrophilic drug sirolimus is very challenging; however, Concept Medical has been able to overcome that challenge. To have a cytostatic drug instead of the cytotoxic drug, especially in longer vessels like the superficial femoral arteries, has been a difficult task. The use of sirolimus does not easily translate from its use in coronary arteries. However, Concept Medical’s smart and elaborate nanotechnology has been able to transfer that safety and efficacy from the coronary arteries to the peripheral arteries. From engineering and pharmacological point of view, to actually bring a balloon to the target lesion and be able to deliver the drug is a remarkable achievement.

Prof. Teichgräber understands that the best way to figure out the safety and efficacy of a safe alternative -limus drug is to compare it directly with the current standard of care, ie, paclitaxel, in a randomized, controlled trial (RCT). He is pleased to announce that he will be the principal investigator of a head-to-head RCT of the MagicTouch PTA Sirolimus Coated Balloon vs a paclitaxel coated balloon family. A RCT is the best methodology to convey a truly safe and effective alternative to current options and the trial should start enrolling patients in 2020. The MagicTouch PTA Sirolimus Coated Balloon is already CE approved and thus ready for commercial availability.

Prof. Teichgräber concludes with a statement that the availability of a sirolimus coated balloon has the potential to redefine the treatment strategy in peripheral arterial disease.