MPO’s Most-Read Stories This Week—June 17

Acquisitions and clinical trial news drove the bulk of MPO website traffic this past week.

Topping pageviews was medical device contract manufacturer (CM) Arterex’s purchase of NextPhase Medical Devices LLC for an undisclosed amount. NextPhase is a class II and III medical device CM of complex electromechanical devices, active implantable devices and single use disposables in North America. The deal doubles the size of the Arterex Group and creates a top-tier global medical device contract manufacturer with 70% of its revenues generated in the United States. The combined Group comprises seven end-to-end manufacturing facilities across North America, Europe, and North Africa, a broad range of manufacturing capabilities, and strong end-market exposure across international markets.

The other purchase of interest to MPO cybervisitors was Merit Medical Systems’ $100 million deal for AngioDynamics’ dialysis catheters portfolio and the BioSentry biopsy tract sealant system. Merit also recently acquired the Surfacer Inside-Out access catheter system from Bluegrass Vascular Technologies for $32.5 million.

Medtronic, meanwhile, tantalized website guests with positive study results. Medtronic’s 12-month clinical study findings support CE Marking for the Affera Mapping and Ablation System, with results showing the Sphere-9 Catheter can successfully treat patients with either paroxysmal or persistent atrial fibrillation (AFib) using various ablation lesion sets. The Sphere-9 Catheter is an all-in-one wide-area focal catheter with pulsed field ablation (PFA), radiofrequency (RF) and high density (HD) mapping capability. The Affera Mapping and Ablation System, which includes the Sphere-9 Catheter and Affera Mapping System, received CE Mark approval in March 2023. Treatment with the Sphere-9 Catheter provided 85% one-year freedom from recurrence of atrial arrhythmias in patients receiving the PULSE3 waveform (the optimized, commercial Affera System pulsed field waveform). In paroxysmal and persistent AF patients who underwent a catheter ablation, 78% of both cohorts remained free from all atrial arrhythmias at the conclusion of the study. The study achieved its primary safety endpoint of 0.6%, including no incidences of atrio-esophageal fistula, coronary spasm, pulmonary vein stenosis, and phrenic nerve injury. 

PECA Labs is aiming for positive results as well with its MASA Valve study, which has begun enrolling patients at four clinical U.S. sites. Designed for pediatrics, the MASA Valve is a polymeric valved conduit for pulmonary valve reconstruction. The polymeric valve previously received FDA Humanitarian Use Device (HUD) and Investigational Device Exemption.

BD (Becton, Dickinson and Company) also attracted cybervisitors this past week by launching the BD FACSDuet premium sample preparation system, an automated instrument that prepares samples for clinical diagnostics using flow cytometry. The system uses liquid-handling robotics to automate sample preparation for in-vitro diagnostics and user-defined tests, including cocktailing, washing, and centrifuging. It then automatically transfers samples to the BD FACSLyric clinical flow cytometry system without human interaction.

1. Arterex Acquires NextPhase Medical Devices

2. Merit Medical Acquires AngioDynamics Catheter Portfolio

3. Study Shows Medtronic’s Sphere-9 Catheter Successfully Treats Afib

4. First Successful In-Human Implant of PECA Labs’ MASA Valve Completed

5. BD Rolls Out Robotic System to Automate Clinical Flow Cytometry