The FDA warning letter has been around for more than a quarter century, and questions about their use and abuse crop up periodically. Perhaps it's time again to ask whether warning letters actually fulfill their purpose, but one gets the feeling that like the horseshoe crab, this is a species that is unresponsive to allegations of obsolescence. Before we go off on warning letters, however, we should acknowledge that Congress is looking into legislation dealing with the medical device inspection imbroglio. But will that change anything about the warning letter...

PARIS – One week before regulations governing the CE mark for medical devices formally takes the force of law, makers of cardiovascular devices have already turned their backs on Europe and are headed to the U.S. for first-to-market approvals. In reforming its law, the European Union has made the new Medical Device Regulation (MDR) so onerous, so complex and so uncertain that the formidable formalities of the U.S. FDA now seem user-friendly, according to discussions during several panel sessions at EuroPCR 2017, Europe's largest congress for interventional cardiology. "The pendulum has swung. The early feasibility...

PARIS – A meta-analysis covering 4,529 patients presented at EuroPCR closed the door on a five-year argument over what diagnostic tool will be the gold standard in the catheterization lab for helping physicians decide whether or not to stent a coronary lesion. The results of the combined results from DEFINE-FLAIR and IFR-SWEDEHEART were already known to cardiologists, having been published in March in the New England Journal of Medicine and concurrently presented at the meeting of the American College of Cardiology. New at EuroPCR was the roll-out of the system for performing the assessment by...

Thermo Fisher Scientific Inc. will acquire drug development and delivery services provider Patheon NV for $7.2 billion, including $2 billion of debt assumption. Diagnostics and laboratory-focused Thermo Fisher expects that the addition of the Durham, N.C.-based contract development and manufacturing organization (CDMO) will add to its offerings for biopharmaceutical customers. The Waltham, Mass.-based company anticipates the deal will be accretive to adjusted EPS by adding $0.30 in the first full year after deal close, which is expected to be before year end. The $35 per share price tag was about a 35 percent premium to...

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...