MPO’s Most-Read Stories This Week—April 16

A new chief executive and regulatory approvals drove MPO website traffic this past holiday week, with Wytech Industries’ leadership change capturing the most online views. The company, a Vance Street Capital portfolio firm, appointed David Ohmann as CEO, effective immediately. Ohmann joined Wytech in May of 2021 as president with more than 25 years of medical device industry experience.

Venus Medtech and LivaNova scored considerable page views as well with their respective European and American regulatory approvals. 

VenusP-Valve, Venus Medtech’s in-house-developed transcatheter pulmonic valve replacement (TPVR) system, received CE marking in early April. Designed to treat patients with moderate to severe pulmonary regurgitation with or without right ventricular outflow tract (RVOT) stenosis, VenusP-Valve marks a new milestone in the global presence of China’s medical devices as it is the first self-expanding TPVR product approved for marketing in Europe, according to the company. Designed with both flared ends, the product provides stable anchoring and easy delivery, with no need for pre-stenting before the procedure. Available in various specifications with extensive applicability, the product is able to meet the needs of 85 percent of patients.  

LivaNova PLC received regulatory approvals and initiated a targeted commercial launch for the Essenz Patient Monitor, which uses a patient-tailored approach to improve clinical efficiency and quality of patient care during cardiopulmonary bypass (CPB) procedures. Having recently received U.S. Food and Drug Administration 510(k) clearance and CE Mark, LivaNova initially launched the Essenz Patient Monitor in the United States and Europe in hospitals that were involved in its user-centric design and development program. Additionally, the patient monitor is compatible with the LivaNova S5 heart-lung machine and will be a key feature of the complete Essenz Perfusion System, which encompasses a next-generation heart-lung machine.

The Essenz Perfusion System is currently under development and is expected to launch in stages later this year beginning with limited commercial launches. 

1. David Ohmann Appointed CEO of Wytech Industries

2. VenusP-Valve Obtains CE Marking

3. LivaNova Receives FDA Clearance and CE Mark for Essenz Patient Monitor

4. Resonetics Acquires EaglePicher’s Medical Power Business