As part of newly announced collaborations with Cleveland-based Viewray Inc., Elekta AB assumed a 9.9% stake in the company, and Medtronic plc also made a minority investment. The company's largest shareholder, Fosun International Ltd., also led the round. "In total, the company raised approximately $139 million, net of fees," Viewray President and CEO Scott Drake told BioWorld MedTech.
The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.
Medtronic plc, of Dublin, reported good news in terms of its quarterly results Tuesday, with key revenue segments coming in line with or beating expectations. Wells Fargo's Larry Biegelsen noted that coronary and structural heart sales of $955 million exceeded the consensus of $949 million and his organization's $923 million estimate. The company pointed to its transcatheter aortic valves as helping in the boost, following the expansion into the low-risk patient population.
Edwards Lifesciences and Medtronic have struggled for supremacy for transcatheter aortic valve devices for several years, but two recent studies suggest the Edwards line of devices provide better outcomes. However, another study gave new life to the notion that TAVR devices are underutilized, signaling that there is plenty of market for both companies.
Dublin-based Medtronic plc is highlighting results from the MARVEL 2 study showing that an investigational set of algorithms in the Micra Transcatheter Pacing System (TPS) helps those with normal sinus node function and atrioventricular (AV) block.
Medtronic plc, of Dublin, has had a busy week. On Tuesday, it reported that it had received breakthrough device designation from the U.S. FDA for its Valiant TAAA stent graft system for the minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA).
Dublin-based Medtronic plc has filed a PMA supplement with the U.S. FDA for its next-generation, implantable sacral neuromodulation (SNM) device, Interstim Micro, and for its Interstim Surescan MRI leads. Interstim Micro is intended to help patients with overactive bladder (OAB), urinary urge incontinence, unobstructed urinary retention and fecal incontinence (FI).
SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.
