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
Catheters
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
TriSalus releases positive data for its catheter-based drug delivery tech
TriSalus Life Sciences today announced positive clinical results for its Pressure-Enabled Regional Immuno-Oncology technology. The company, currently in the process of going public through a SPAC merger, filed a presentation for investors. It features information regarding its ongoing PERIO 01 and PERIO 02 clinical studies. The studies evaluate … [Read more...] about TriSalus releases positive data for its catheter-based drug delivery tech
Why Affera’s cardiac ablation technology is worth $1B to Medtronic
Affera started in 2014 with a simple goal that paid off when Medtronic (NYSE:MDT) bought the company for up to $1 billion this year. Achieving that goal, however, took some unconventional and sometimes difficult design choices, Affera founder and CEO Doron Harlev said. Newton, Massachusetts–based Affera's system diagnoses, maps and treats … [Read more...] about Why Affera’s cardiac ablation technology is worth $1B to Medtronic
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
Acutus Medical submits AcQBlate force-sensing ablation catheter for FDA premarket approval
Acutus Medical today announced it submitted pivotal clinical data of its AcQBlate force-sensing ablation catheter to the FDA for premarket approval. The Carlsbad, California-based company submitted data from the AcQForce Flutter trial, a prospective, multicenter, non-randomized study approved under an FDA investigational device exemption … [Read more...] about Acutus Medical submits AcQBlate force-sensing ablation catheter for FDA premarket approval
