This year was a big one for catheter innovation as medtech companies large and small received regulatory approvals and researchers developed catheters that could soon make navigating the vasculature system easier. The numerous innovations weren't just limited to adults. One company launched a cryoablation catheter for children as young as 2 … [Read more...] about The top 10 catheter innovation news stories of 2022
Endologix AFX2 system wins FDA approval for PMA supplement
Endologix today announced it received FDA approval for a pre-market approval supplement relating to its AFX2 system. The expanded approval includes an updated warning and the most contemporary clinical information in the labeling for the AFX2 system. Clinical data was added to the instructions for use (IFU) to include: - Final results … [Read more...] about Endologix AFX2 system wins FDA approval for PMA supplement
Medtronic completes enrollment in pulsed-field ablation catheter trial
Medtronic today announced it completed enrollment and final treatment in the Sphere Per-AF pivotal trial to study Affera's pulsed-field ablation catheter tech. The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with … [Read more...] about Medtronic completes enrollment in pulsed-field ablation catheter trial
Catheter Precision’s VIVO System treats more than 800 patients
Catheter Precision today announced that more than 800 procedures have been performed using its VIVO System in the U.S. and Europe. The VIVO (View Into Ventricular Onset) System allows physicians to noninvasively identify an area of ventricular arrhythmia onset. It uses noninvasive 3D imaging that identifies the origin of arrhythmias … [Read more...] about Catheter Precision’s VIVO System treats more than 800 patients
NuVasive launches Tube System and Excavation Micro for posterior spine surgery
NuVasive this week announced the commercial launch of its NuVasive Tube System (NTS) and Excavation Micro for minimally invasive posterior spine surgery. The San Diego-based orthopedic company designed the NTS and Excavation Micro to provide comprehensive solutions for TLIF and decompression procedures. It adds to the company's access and … [Read more...] about NuVasive launches Tube System and Excavation Micro for posterior spine surgery
Surmodics beats The Street in Q4 results, grows sales 8%
Surmodics (Nasdaq:SRDX) today posted fourth-quarter results that beat the overall consensus on Wall Street. The Eden Prairie, Minnesota-based IVD tech developer reported net losses of $14.7 million, or -$1.06 per share, on sales of $25.99 million for the three months ended Sept. 30, representing a sales growth of 8.41% compared to Q4 2021. The … [Read more...] about Surmodics beats The Street in Q4 results, grows sales 8%
Baylis Medical Technologies, Oscor sign distribution agreement
Baylis Medical Technologies today announced it signed a sales and distribution agreement with Oscor. Through the agreement, Boston Scientific's Baylis will distribute Oscor's steerable and guiding sheaths that are currently sold direct-to-hospital. It will allow Baylis to broaden its clinical solution offerings in radiology and vascular … [Read more...] about Baylis Medical Technologies, Oscor sign distribution agreement
MedAlliance’s Selution SLR wins FDA IDE approval for in-stent restenosis
MedAlliance today announced it received FDA investigational device exemption (IDE) approval for its Selution SLR to initiate its coronary pivotal clinical trial for in-stent restenosis. Geneva-based MedAlliance's Selution SLR is a drug-eluting balloon that is indicated for below-the-knee and superficial femoral artery (SFA) indications, for … [Read more...] about MedAlliance’s Selution SLR wins FDA IDE approval for in-stent restenosis
Catheter Precision expands Vivo imaging system customer base in U.S.
Catheter Precision recently announced it expanded its U.S. customer base for the Vivo non invasive 3D imaging system. Vivo is a non-invasive 3D imaging system that allows physicians to identify the location of arrhythmias pre-procedure. It received FDA clearance at the end of 2020 and was strategically launched in the U.S. in 2021. Vivo has also … [Read more...] about Catheter Precision expands Vivo imaging system customer base in U.S.
NeoChord announces positive study results from transcatheter mitral chordal repair device
NeoChord recently announced positive results from a clinical study of its transcatheter NeXuS system for mitral chordal repair. The company's global early feasibility study treated patients with the transcatheter NeXuS system and results at one-year follow-up demonstrated notable clinical benefit and patient physiological improvement, according … [Read more...] about NeoChord announces positive study results from transcatheter mitral chordal repair device