Presentations include late-breaking results of six-month pooled analysis of data from the RADIANCE™ Global Clinical Trial Program

Recor Medical, Inc. (“Recor”), a subsidiary of Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), will present data from several clinical studies of the Paradise® Ultrasound Renal Denervation (uRDN) system in the treatment of hypertension at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco.

A late-breaking presentation of a six-month pooled analysis of individual patient data from the RADIANCE™ Global Clinical Trial Program will be presented by Dr. Ajay Kirtane on Thursday, October 26, at 2:00 PM PDT. The RADIANCE pooled analysis includes data from patients randomized in the three studies from Recor’s RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-to-moderate hypertension.

In addition to the late-breaking presentation, three moderated abstracts will be presented on Wednesday, October 25:

  • Eight-year results from the ACHIEVE study, an investigator sponsored research study, will be presented by Victor Zeijen at 9:18 AM PDT.
  • Six-month results from the RADIANCE II pivotal trial will be presented by Prof. Michel Azizi at 9:27 AM PDT.
  • Changes in blood pressure after crossover to Ultrasound RDN: a patient-level pooled analysis of the RADIANCE trials will be presented by Dr. Michael Bloch at 3:27 PM PDT.

Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poor quality of life, and higher costs to health systems. The Paradise Ultrasound RDN system previously received CE mark and has been successfully introduced in Europe and is an investigational device in the United States and Japan.

The Recor Medical team will also exhibit at booth #1737.

Full list of presentation details:

Session: Moderated abstracts – Renal Denervation Techniques and Outcomes I

Title: TCT 210: Long-term Safety and Efficacy of Endovascular Ultrasound Renal Denervation in Resistant Hypertension: 8-year results from the ACHIEVE study

Presenter: Victor Zeijen

Date: Wednesday, October 25, 2023

Time: 9:18 AM PDT

Location: Moderated Abstracts Station 5 – Emerging Clinical Science & Research, Hall C, Exhibition Level, Moscone South, Moscone Center

Session: Moderated abstracts – Renal Denervation Techniques and Outcomes I

Title: TCT 398: Endovascular Ultrasound Renal Denervation to Treat Uncontrolled Hypertension: Six-Month Results Following Blinded Medication Titration in the Randomized, Sham-Controlled RADIANCE II Pivotal Trial

Presenter: Prof. Michel Azizi

Date: Wednesday, October 25, 2023

Time: 9:27 AM PDT

Location: Moderated Abstracts Station 5 – Emerging Clinical Science & Research, Hall C, Exhibition Level, Moscone South, Moscone Center

Session: Renal Denervation Techniques and Outcomes II

Title: TCT 325: Changes in Blood Pressure after Crossover to Ultrasound Renal Denervation: Patient-Level Pooled Analysis of the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO and RADIANCE-HTN TRIO Trials

Presenter: Dr. Michael Bloch

Date: Wednesday, October 25, 2023

Time: 3:27 PM PDT

Location: Moderated Abstracts Station 3 – Emerging Clinical Science & Research, Hall A, Exhibition Level, Moscone South, Moscone Center

Session: Late-Breaking Clinical Science: Session III, in Collaboration with the European Heart Journal/EuroIntervention

Title: Individual Patient-data Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure at 6 Months in the RADIANCE Clinical Trial Program

Presenter: Ajay Kirtane

Date: Thursday, October 26, 2023

Time: 2:00 PM PDT

Location: Innovation & Clinical Science Theater, Hall B, Exhibition Level, Moscone South, Moscone Center

About Recor Medical, Inc.

Recor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise system is an investigational device in the United States and Japan, and is CE marked and approved for sale in markets where CE mark is accepted. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension. In addition, Recor has begun the Global Paradise System (“GPS”) Registry in the EU, with plans to expand globally.

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices focuses on the global development and commercialization of medical care products including endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).

https://www.omd.otsuka.com/en/

Contacts

Tressa Frankel

Health+Commerce

tressa@healthandcommerce.com

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