Medical Devices treating Hypertension NEWS in the last 12 months: Retrospective Analysis of the sector from March 2023 until March 2024
According to World Health Organization there are more than 700 million people in the World with untreated hypertension
One of the treatment options is renal denervation catherization procedure. Renal denervation reduces activity in the renal nerves in the kidneys to help lower blood pressure. An interventional cardiologist uses a catheter to send ultrasound or radiofrequency (heat) energy to the renal arteries, the blood vessels supplying blood to the kidneys.
The radiofrequency ablation catheter was first developed to deliver heat to destroy nerves in the adventitial layer of renal arteries. Other techniques to ablate the renal nerve included intravascular ultrasound ablation and alcohol-mediated renal nerve ablation via a Peregrine catheter.
What happened in Hypertension and Renal Denervation MedTech market between March 2023 and now?
Aria CV implants first patient with pulmonary hypertension system in February 2024.
The early feasibility study aims to enrol 30 participants to evaluate the balloon device.
Aria CV’s device, which was granted US Food and Drug Administration breakthrough designation in 2020, aims to reduce cardiac workload. It is implanted in the main pulmonary artery and designed to restore the vessel’s healthy status, thereby mitigating right heart failure. According to the company, the device is driven by the heart and has no battery, pump or electronics.
The Gen 2 Aria CV Pulmonary Hypertension System is a gas-filled balloon designed to mimic the function of healthy vessels, which helps the heart pump at a more normal rate and improves blood flow to the lungs. It is implanted percutaneously and guided directly to the patient’s main pulmonary artery.
SoniVie completes enrolment in renal denervation study in February 2024.
A total of 40 patients with resistant hypertension will be involved in the study as the renal denervation space attracts new joiners.
More companies are looking to join the burgeoning renal denervation market, with Israeli startup SoniVie completing enrolment in a pilot study for its TIVUS (therapeutic intra-vascular ultrasound) system.
The REDUCED-1 pilot (NCT05372679), which is being conducted across the US and Israel, has enrolled two cohorts of patients with uncontrolled stage 2 hypertension. The company enrolled 25 patients in the US and 15 in Israel.
Ablative Solutions hits primary endpoint in renal denervation for hypertension trial in December 2023.
Ablative Solutions announced today that its TARGET BP I pivotal trial evaluating its Peregrine System kit met its primary endpoint.
The trial evaluates alcohol-mediated renal denervation to treat hypertension with the Peregrine System. Wakefield, Massachusetts-based Ablative Solutions reported a statistically significant difference in 24-hour ambulatory blood pressure between treatment and sham procedure at three months.
Bioheart renal denervation trial adds more evidence to hypertension treatment option in July 2023.
Chinese renal denervation trial adds more evidence to hypertension treatment option
In the prospective, multi-centre, blinded and randomised study (NCT02901704), 217 Chinese patients with primary hypertension were split into a renal denervation group and a renal angiography (sham) group.
Patients who underwent renal denervation with Bioheart’s Iberis device achieved the primary endpoint by demonstrating a reduced average 24-hour ambulatory systolic blood pressure from baseline at a three-month follow-up. These patients’ blood pressure was reduced by 11.93 mmHg compared to 2.58 mmHg in the sham group. Bioheart also reported no device-related major adverse events.
Bioheart, which is a subsidiary of Netherlands-based Angiocare, claims it is the only renal denervation system with CE marking that can be used for transradial approach (TRA) and transfemoral approach (TFA).
Verve Medical Announces FDA Approval of IDE for Pivotal Trial of RPD™ Renal Pelvic Denervation System for Treatment of Uncontrolled Hypertension in July 2023
Verve Medical, Inc. (Verve) announced today that the Company has received approval from the US Food & Drug Administration (FDA) to initiate its Natural Orifice via renal pelvis denervation (NOVEL- Denervation) Pivotal IDE trial for the treatment of uncontrolled hypertension to lower blood pressure.
FDA approves Metavention’s renal denervation for hypertension pivotal IDE study in June 2023.
Metavention announced today that the FDA granted approval to initiate an investigational device exemption (IDE) trial for its renal denervation system.Minneapolis-based Metavention designed its integrated radiofrequency (iRF) renal denervation system to treat hypertension. The company plans for its randomized, double-blinded, sham-controlled RADAR study to enroll up to 300 patients across 50 centers. This pivotal study evaluates the safety and efficacy of the iRF renal denervation system.
Kalos Medical Receives Korean MFDS Innovative Medical Device Designation for DENEX Hypertension Treatment System in June 2023.
Kalos Medical Inc. (“Kalos Medical”), a developer of innovative medical devices treating hypertension and other chronic illnesses, announced on June 23rd that South Korea’s Ministry of Food and Drug Safety (“MFDS”) designated the company’s DENEX hypertension treatment system as an Innovative Medical Device, a designation that recognizes medical devices that significantly improve safety and efficacy compared to existing medical devices and treatments.
The DENEX system is an innovative medical device that treats hypertension using minimally invasive renal denervation technology. Electrodes are inserted into the renal artery through a thin catheter tube to sympathetic nerve locations in the kidneys. The device then uses radiofrequency energy applied to the arterial wall to inactivate portions of the sympathetic nerves, which has been demonstrated to be effective at lowering blood pressure. Unlike laparoscopic surgery, the DENEX system procedure is short and safe, without the negative side effects associated with general anesthesia.
Gradient Denervation is conducting a first-in-human study for its minimally invasive device in June 2023.
Paris-based Gradient Denervation Technologies has performed the first procedure in its first-in-human clinical study for a pulmonary hypertension device.
The medical device company is the developer of intravascular, catheter-based technology to treat patients with thickened and narrowed pulmonary arteries. Though currently classed as a rare disease (affecting less than one in 2000 people in Europe), treatment options are limited and there is no cure as of yet.
Gradient’s technology, based on prior research and intellectual property developed at Stanford University, aims to reduce pulmonary vascular resistance, and improve cardiovascular hemodynamics by downregulating the sympathetic nervous system’s input into the pulmonary vascular tree.
The successfully completed first patient procedure was performed at the Helsicore Hospital in Tbilisi, Georgia.
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