MIVI Neuroscience’s next-generation DAISe blood clot management system has had its first-in-human use for treatment of ischemic stroke. The procedure took place in South America, the company said in a statement. DAISe is designed to remove a clot as well as filter and capture clot emboli that fracture during removal. It has a three-dimensional, vessel-conforming meshwork […]
CHF Solutions prices $5m offering
CHF Solutions (NSDQ:CHFS) last week priced a $4.7 million offering to support expanding its field sales force and commercial organization. The Eden Prairie, Minn.-based company said it plans to offer 2.2 million shares of its common stock at $2.12 per share. The offering includes a 45-day underwriter’s option for an additional 332,239 shares at the public […]
CMS opens NCA to reconsider TAVR coverage
The Centers for Medicare and Medicaid have opened a National Coverage Analysis looking to reconsider its National Coverage Determination for transcatheter aortic valve replacement procedures. Medicare’s NCD for TAVR was established in 2012 with strict criteria for reimbursement and procedure performance that limited TAVR to high-volume hospitals and medical centers. Requirements in the 2012 decision […]
Medtronic wins $472m cardio device DoD contract
Medtronic (NYSE:MDT) won a $471.6 million contract with the US Department of Defense to provide it with cardiovascular products, according to a DoD release posted yesterday. The fixed-price with economic-price-adjustment, indefinite-deliver/indefinite-quantity contract is a sole-source acquisition deal for cardiovascular products, according to the release. The deal comes with a single year base contract and four one-year […]
Study: Leadless pacers lead to less complications
Patients who’ve received leadless pacemakers experience fewer complications than traditional pacers, according to a new study from the Cleveland Clinic. Results from the study were published in the journal Heart Rhythm. Investigators in the multi-center study compared short and mid-term complications between 718 patients who received Abbott‘s (NYSE:ABT) Nanostim leadless pacer and 1,436 patients who received conventional […]
Analyst’s rating changes push Cardiovascular Systems up, NuVasive and Globus down
Ratings changes by an analyst with Bank of America-Merrill Lynch elevated one medical device company’s stock today in pre-marker trading but pushed two others down. Appearing this morning on Bloomberg television, BAML’s Bob Hopkins said Wall Street isn’t foucsed enough on the July 31 investor day at Cardiovascular Systems (NSDQ:CSII), according to Seeking Alpha. The St. Paul, […]
7 medtech stories we missed this week: June 22, 2018
From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in […]
GPB Capital puts $21m into CardioFocus for HeartLight catheter launch
CardioFocus landed a $21 million debt investment from GPB Capital and plans to use the proceeds to back the commercial launch of its HeartLight catheter for treating atrial fibrillation. The funding consists of a $21 million senior secured convertible note due to mature in April 2021. CardioFocus, which won FDA approval for its HeartLight Excalibur balloon last month, […]
No new trial for Bard in $4m vena cava filter loss
Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard this week failed to win a new trial after a jury awarded nearly $4 million to the plaintiff in a bellwether product liability lawsuit brought over Bard’s inferior vena cava filter. Plaintiff Sherr-Una Booker was implanted in June 2007 with a Bard G2 IVC filter to mitigate her risk […]
JenaValve launches CE Mark study of next-gen TAVR system
JenaValve Technology said this week it launched a new study of its next-generation pericardial transcatheter aortic valve replacement systems using its Coronatix transfemoral delivery catheter. In the newly launched trial, the Irvine, Calif.-based company will explore the use of the system as a treatment for severe aortic regurgitation in patients who are at high risk for […]
Abbott escapes payer’s lawsuit over St. Jude Medical CRM batteries
Abbott (NYSE:ABT) this week escaped a purported class action lawsuit brought by a third-party payer over defective batteries used in subsidiary St. Jude Medical‘s cardiac rhythm management devices. Plaintiff ASEA/AFSCME Local 52 Health Benefits Trust brought the suit last September on behalf of third-party payers, alleging in the U.S. District Court for Northern Illinois that Abbott and St. […]
MassDevice Network
@MassDevice
LinkedIn
Google+