Medtronic has received the US Food and Drug Administration (FDA) approval for its Symplicity Spyral renal denervation (RDN) system for the minimally invasive treatment of hypertension.
The Spyral RDN system is also known as the Symplicity blood pressure procedure.
It is an advanced, minimally invasive procedure in which radiofrequency energy is delivered to nerves surrounding the kidneys that can become overactive and lead to high blood pressure.
As part of the procedure, a doctor would insert a single thin tube (catheter) into the patient’s artery that leads to the kidney, after sedating the patient.
Once the catheter is in place, radiofrequency energy is administered to calm the excessive activity of the nerves connected to the kidney and is removed, leaving no implant behind.
With the FDA approval, Medtronic is planning to start commercialising the device immediately.
Medtronic coronary and renal denervation business senior vice president and president Jason Weidman said: “Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most.
“It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure.
“The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension.”
According to the company, hypertension is a major, modifiable cause of heart attack, stroke, and death, with lower control rates despite medications and lifestyle interventions.
Medtronic said it has considered patient preference and shared decision-making as critical components in the development of its Symplicity blood pressure procedure.
The company conducted a comprehensive, global clinical programme, dubbed SPYRAL HTN.
In the programme, the RDN system was evaluated in more than 25,000 patients, with and without medication, and in patients with high baseline cardiovascular risk.
The renal denervation system is currently allowed only for investigational use in Japan, China and Canada, and is approved for commercial use in more than 70 countries worldwide.
SPYRAL clinical programme co-principal investigator David Kandzari said: “The Symplicity blood pressure procedure is safe and effective, providing significant ‘always on’ blood pressure reductions for patients.
“This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study.”
SPYRAL clinical programme co-principal investigator Raymond Townsend said: “The Symplicity blood pressure procedure is a promising treatment option for clinicians and patients alike and offers an opportunity to fulfil a significant unmet need in hypertension care, especially for those patients who are desperately seeking additional approaches to get their blood pressure down.”
