A hospital in Texas announced today that its electrophysiologists completed the first U.S. cases with the Medtronic (NYSE:MDT) Affera platform. EPs at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center performed the procedures with Affera. Dr. Andrea Natale and Dr. Amin Al-Ahmad conducted the first procedure on Nov. 7. A … [Read more...] about First U.S. cases performed with Medtronic Affera ablation system
Catheters
InnoCare Urologics wins FDA nod for urinary safety catheter
InnoCare Urologics announced today that it received FDA 510(k) clearance for its novel urinary safety catheter. The Miami-based company says it marks the first-ever FDA clearance under a new code for urinary catheters with safety features. InnoCare designed its Egress safety catheter to eliminate the injuries that occur when traditional … [Read more...] about InnoCare Urologics wins FDA nod for urinary safety catheter
FastWave Medical secures sixth patent for IVL portfolio
FastWave Medical today announced the sixth U.S. utility patent for its laser-based intravascular lithotripsy (IVL) technology for treating calcific artery disease. This is the fourth patent that Minneapolis-based FastWave Medical has secured from the U.S. Patent and Trademark Office this year. The company announced previous patents in May and … [Read more...] about FastWave Medical secures sixth patent for IVL portfolio
Abbott reports first cases with software-guided balloon-expandable TAVI
Abbott (NYSE:ABT) today announced the first patient procedures with its investigational transcatheter aortic valve implantation (TAVI) system. The company designed its investigational software-guided, balloon-expandable TAVI system to build a foundation for AI-guided procedures. It hopes to add the expandable system to its structural heart … [Read more...] about Abbott reports first cases with software-guided balloon-expandable TAVI
Boston Scientific to acquire hepatic artery infusion pump maker Intera Oncology
Boston Scientific (NYSE:BSX) announced today that it agreed to acquire infusion pump maker Intera Oncology for an undisclosed amount. Intera Oncology develops the Intera 3000 hepatic artery infusion pump and floxuridine, a chemotherapy drug. Both hold FDA approval. The pump administers hepatic artery infusion (HAI) therapy to treat tumors in the … [Read more...] about Boston Scientific to acquire hepatic artery infusion pump maker Intera Oncology
Supira begins early feasability study for percutaneous ventricular assist device
Supira Medical announced today that it began patient enrollment in a U.S. early feasibility trial of its percutaneous ventricular assist device (pVAD). The Shifamed portfolio company plans to evaluate the pVAD in patients undergoing high-risk percutaneous coronary intervention (HRPCI). Los Gatos, California-based Supira’s study looks at the … [Read more...] about Supira begins early feasability study for percutaneous ventricular assist device
Route 92 Medical picks up CE mark for stroke portfolio
Route 92 Medical announced today that it received CE mark for its line of neurovascular intervention products for treating stroke. The company also picked up clearance under the MDSAP program, giving broad access to international markets. Authorization covers the majority of the company's products, including: HiPoint 70/Tenzing 7 … [Read more...] about Route 92 Medical picks up CE mark for stroke portfolio
EndoTheia completes first-in-human study of steerable kidney stone basket
EndoTheia announced today that it completed the first-in-human clinical trial for its FlexStone basket, a steerable kidney stone treatment. Nashville, Tennessee-based EndoTheia said its FlexStone basket represents the first-ever independently steerable kidney stone basket. It enables precision and control in kidney stone removal by letting … [Read more...] about EndoTheia completes first-in-human study of steerable kidney stone basket
JenaValve to begin Trilogy heart valve trial
JenaValve announced today that it received the green light to begin a new randomized controlled trial for its Trilogy device. Irvine, California-based JenaValve can now start the ARTIST trial, slated for early next year. The company — set to be acquired by Edwards as part of a $1.2 billion double M&A swoop alongside Endotronix — also … [Read more...] about JenaValve to begin Trilogy heart valve trial
Endologix reports positive 3-year Detour PAD treatment data
Endologix announced the final 36-month results for the DETOUR2 study evaluating its Detour system for treating peripheral arterial disease (PAD). Detour features the EndoCross device and Torus stent grafts. It enables physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein. This restores … [Read more...] about Endologix reports positive 3-year Detour PAD treatment data
