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CHICAGO – Results from the EWOLUTION registry show that Boston Scientific Corp.'s Watchman Left Atrial Appendage (LAA) Closure device was effective in stroke reduction for patients with non-valvular atrial fibrillation (AF), including those patients deemed unsuitable for oral anticoagulation. The study was presented at the Heart Rhythm Society's 38th annual Scientific Sessions on Friday. The prospective, single-arm, multicenter EWOLUTION registry evaluated 1,025 patients with non-valvular AF who have a high risk for stroke and systemic embolism. In the study, patients were enrolled at 47 centers throughout Europe, Russia and the Middle East. More than 70...
CHICAGO – A post-market study of Boston Scientific Corp.'s subcutaneous ICD (S-ICD) supports long-term use of the device in patients. Michael Gold, president of the Heart Rhythm Society presented the results during a late breaking clinical trials session at the conference. Results of the study are set to be published in the latest edition of the Heart Rhythm Journal. Acute results demonstrate the therapy effectively terminated life-threatening heart arrhythmias in 98.7 percent of evaluated patients. The S-ICD System analysis also validated low complication rates, with a complication-free rate of 96.2 percent at 30 days post-procedure....
CHICAGO – Atrial fibrillation (AF) impacts about 33 million patients worldwide. Med-tech companies have responded to the challenge AF presents and have developed a number of ablation technologies to treat the disease. On Tuesday, a panel at this year's Heart Rhythm Society's (HRS) Scientific Sessions discussed some of the devices on the forefront of AF Ablation. Nearly 10 years ago, med-tech companies went on a spending spree to either enter the AF market or secure a stronger foothold in it. These companies include Abbott Laboratories Inc.'s St. Jude Medical, which acquired West Berlin, N.J.-based EP...
A tissue treatment device that can participate in the biotech-driven immuno-oncology fervor of the last few years may sound too good to be true. That's precisely the case being made by long-short hedge fund Kerrisdale Capital Management LLC, which has issued a report critical of the science behind early stage Pulse Biosciences Inc. and holds a short position betting against it. During February and March, the Burlingame, Calif.-based company saw its valuation jump from less than $100 million to more than $450 million after high-profile investors Robert Duggan and Mahkam Zanganeh, respectively the former CEO...
CHICAGO – An 18 millimeter capsule colonoscope, outfitted with an internal magnet and guided by an external magnet attached to a robotic arm, may represent the next generation of colonoscopy technology, according to findings presented at Digestive Disease Week (DDW) 2017 in Chicago. "Colonoscopy saves lives through colon cancer screening, in that it can both identify and remove precancerous lesions and tumors," observed Keith Obstein, associate professor of medicine at Vanderbilt University Medical Center. "Unfortunately, a large segment of the population foregoes age-recommended colon cancer screening." The reasons are well known to clinicians, principally fear...
CHICAGO – Conventional weight loss surgery – whether laparoscopic banding or laparoscopic sleeve gastrectomy – represents an important treatment option for individuals struggling to fight obesity. Not every patient seeking weight loss surgery is a candidate for these procedures, however. Now, these individuals may have another option. A study presented Saturday at Digestive Disease Week (DDW) 2017 in Chicago and featured in the meeting's press conference suggested that individuals with obesity who are not candidates for weight loss surgery may benefit from nonsurgical endoscopic sleeve gastroplasty (ESG), a procedure performed at a growing number of...
Cerus Corp. is optimistic that its Intercept blood system will become the standard of care in the U.S. when it comes to pathogen reduction in donor plasma and platelets. But it's been more than a couple of years since the Concord, Calif.-based company first won FDA approval in those indications. Now, it's working on a phase III clinical trial program aimed at expanding the technology's application into the broader market for pathogen reduction in red blood cells (RBCs) by the end of the decade. Cerus is also awaiting a final FDA guidance on bacterial safety...
Livanova plc sees transcatheter mitral valve replacement (TMVR) is coming up next as a multibillion segment following on TAVR. To secure what it expects will be market-leading technology, the London-based company has acquired Maple Grove, Minn.-based Caisson Interventional LLC. Sorin SpA and Cyberonics Inc. merged in the fall of 2015 to become Livanova; Sorin had been a Caisson investor since 2012. Livanova has acquired the remaining 51 percent of Caisson for $78 million in cash, milestones and debt forgiveness. APPROACH ADVANTAGE? Caisson's TMVR implant is the only one designed entirely for use via a transseptal...
Hedge fund giant KKR sees opportunity in a new investment approach to the medical device space. Alongside life science private equity player Aisling Capital, KKR has created Ajax Health to enable it to provide financial and operational support to medical device companies. MED-TECH OPPORTUNITY It aims to opportunistically invest in roughly seven to 10 device companies that have only one or two significant remaining risks until they reach a major inflection point. Roughly $15 million to $30 million will be invested in total for each company. The first Ajax company is Advanced Cardiac Therapeutics Inc....
True to their word, U.S. lawmakers are pushing forward with plans to give the NIH its second consecutive $2 billion funding bump. Included in an omnibus spending bill Congress is slated to vote on in a few days, the increase ignores President Donald Trump's request for a $1.2 billion cut in NIH funding for the remainder of fiscal 2017 to help pay for more spending on defense. Largely due to that bump, the Department of Health and Human Services (HHS) – which includes the FDA, NIH, CDC, as well as other agencies – is slated...
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines...
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s...
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS...
After being in the doldrums for the majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing.
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