Concept Medical just received a huge burst of speed in its quest to get its drug-coated balloon for the treatment of peripheral artery disease (PAD) commercially available in the U.S.
The Tampa, FL-based company has received breakthrough device designation from FDA for the MagicTouch PTA, a Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK).
So far, Concept Medical said MagicTouch has been performing extremely well. In the XTOSI pilot study, the majority of patients enrolled had major comorbidities (diabetes and end-stage renal failure) and the indication for angioplasty was for severe critical limb ischemia (more than 90% had the most severe Rutherford scores of 5 or 6). The extent of PAD treated was also severe, and about 80% of patients did not have any patent BTK arteries before angioplasty.
“I am very encouraged by the excellent results so far in these challenging cohort of patients. device and technical success were both 100%,” Associate Professor Edward CHOKE, Principal Investigator of the study and Chief of Vascular Surgery, Sengkang General Hospital, Singapore said in a release. “Freedom from the device and procedure-related mortality was 100%. Limb salvage rate at 30 days was 97%. At six months, freedom from clinically-driven target lesion revascularization was 91%; and primary patency, independently and blindly assessed by duplex ultrasound, was 82%. I did not encounter any distal embolization or 'slow flow phenomenon' after the application of SCB in BTK vessels.”
Concept Medical has had strong support for Magic Touch, as evidenced by the company raising $60 million for an IDE of the technology in October of 2018.
Becton Dickinson & Co. hasn’t fared as well with its DCB. Just a few days ago, the Franklin Lakes, NJ-based company revealed during a quarterly earnings call, FDA rejected its Lutonix Paclitaxel DCB for PAD BTK.
DCB’s along with drug-eluting stents that use paclitaxel as the drug has come under fire recently, which most likely played a role in the agency’s decision to reject BD’s Lutonix for BTK PAD. The company inherited the device through the $24-billion acquisition of C.R. Bard, a deal that closed at the tail end of 2017.