Oct. 19, 2014, 6:28 PM
Oct. 9, 2014, 10:13 AM
- The Circulatory System Devices Panel of the Medical Devices Advisory Committee votes 6 to 5 with one abstention in favor of the opinion that the benefits outweigh the risks of Boston Scientific's (BSX -0.5%) Watchman LAAC Device.
- The panel votes in favor of the device's safety but votes 7 to 6 against the reasonable assurance that the device is effective.
Oct. 6, 2014, 4:31 PM
- The Circulatory System Devices Panel of the Medical Devices Advisory Committee meets on Wednesday, October 8 to review the premarket approval application of Boston Scientific's (BSX) Watchman Left Atrial Appendage Closure Technology. The panel will review new clinical data and associated additional adverse events including stroke that have become available since the previous advisory meeting on the Watchman device which was held on December 11, 2013.
- Panel questions; executive summary
- On October 9, the panel will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves. Currently, the products are considered preamendment devices that are unclassified and reviewed under the 510(k) process.
- Regulatory reference sheet; executive summary; panel questions
Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
Sep. 24, 2014, 5:16 PM| Comment!
Sep. 17, 2014, 11:17 AM
- Boston Scientific (BSX +0.8%) receives CE Mark clearance for its Vercise Deep Brain Stimulation (DBS) System for the treatment of tremor, including essential tremor.
- The Vercise DBS System delivers precise neural targeting and multiple independent current control which allows physicians to customize therapy for their ET patients.
Jul. 24, 2014, 7:25 AM
- Boston Scientific (NYSE:BSX) Q2 results: Worldwide Net Sales: $1,873M (+3.5%), Interventional Cardiology: $528M (+1.5%), Peripheral Interventions: $211M (+3.4%); Cardiac Rhythm Management: $497M (+4.6%); Electrophysiology: $56M (+55.6%); Endoscopy: $333M (+4.1%); Urology&Women's Health: $133M (+7.3%); Neuromodulation: $114M (+2.7%).
- COGS: $563M (+6.2%); R&D Expense: $206M (-7.6%); SG&A Expense: $743M (+12.4%); Operting Income/Loss: ($69M) (-131.4%); Net Income: $4M (-96.9%); EPS: $0.00 (-100.0%); Quick Assets: $357M (+64.5%).
- 2014 Guidance: Revenue: $7.325B - 7.425B from $7.300B - 7.500B; EPS: $0.28 - 0.32 from $0.36 - 0.41.
- Q3 Guidance: Revenue: $1.790B - 1.840B; EPS: $0.08 - 0.10.
Jul. 24, 2014, 7:03 AM| Comment!
Jul. 23, 2014, 5:30 PM
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Jul. 14, 2014, 9:12 PM
- Boston Scientific (BSX -2%) receives CE Mark clearance for its 25 mm Lotus Transcatheter Aortic Valve Implantation (TAVI) System and commences its commercial launch in Europe. The size complements the company's currently available offerings of 23 mm and 27 mm.
- VP & GM Tom Fleming says, "We believe the addition of the 25 mm size will offer our Lotus users an important treatment option for patients with severe aortic valve disease. Commercializing the 25 mm valve only seven months after our initial launch of the Lotus Valve System demonstrates our commitment to advancing therapies and improving patient outcomes."
May. 21, 2014, 10:42 AM
- The FDA approves Direct Flow Medical's IND for its transcatheter aortic valve system allowing the company to initiate its SALUS clinical trial. The study will evaluate the safety and effectiveness of the product in as many as 30 sites.
- Direct Flow says its system minimizes the risk of post-procedural aortic regurgitation by virtue of its sealed annulus and by being fully repositionable to achieve optimal hemodynamic performance.
- Related tickers: (EW) (BSX)
May. 21, 2014, 10:17 AM
- Further credentialing its transcatheter aortic valve implantation (TAVI) technology, Boston Scientific's (BSX +1.3%) Lotus valve system demonstrates sustained safety and effectiveness outcomes at six months in the 130-patient 16-site REPRISE II single-arm study in Europe and Australia.
- The primary device performance endpoint of 30-day mean aortic valve pressure gradient of 18 mmHg was substantially surpassed with a value of 11.5 +/- 5.2 mmHg. At six months the value remained low and stable at 11.4 +/- 4.6 mmHg.
- 79.8% of patients had no paravalvular aortic regurgitation and no patient had a severe case. All-cause mortality rate was 8.4% and the disabling stroke rate was 3.4%.
- The Lotus Aortic Valve System is CE Mark approved but investigational in the U.S.
May. 15, 2014, 7:41 AM
- Boston Scientific (BSX) has agreed to acquire Bayer's (BAYRY) Interventional device business for $415M.
- The deal that will strengthen Boston's portfolio of products for treating peripheral vascular disease, with the company to receive systems used in cardiology, radiology and peripheral vascular procedures.
- The unit generated $120M in sales last year. (PR)
May. 8, 2014, 6:32 PM
- Boston Scientific (BSX) received a subpoena this week from the Department of Health and Human Services seeking information about the performance of some of its implanted defibrillators, according to its latest 10-K filing.
- The subpoena was issued by HHS's Office of the Inspector General, which is responsible for identifying fraud and waste in government health programs such as Medicare and Medicaid.
- Last year, BSX paid $30M to settle Department of Justice allegations that its Guidant subsidiary a decade ago had knowingly sold defective defibrillators that were implanted in Medicare patients.
May. 7, 2014, 12:18 PM
- The FDA approves the Entovis pacemaker system with ProMRI technology made by Berlin, Germany's Biotronik. The device allows patients to undergo MRI scans with a limited exclusion zone. Entovis patients need only to alert radiology staff and they will verify that they are eligible to undergo the imaging. The company believes that this is a significant advantage over MRI-conditional pacers. The FDA's approval covers both single and dual chamber pacemakers when implanted with Setrox leads.
- Recent research finds that there is a 50 - 75% probability that patients implanted with a pacemaker or defibrillator will need an MRI at some point in their lives.
- (BSX) (MDT) (STJ)
May. 6, 2014, 6:15 PM
- Owning a minority interest of 28% apparently wasn't enough for Boston Scientific (BSX -0.9%) because it bought the rest of pre-commercial stage IoGyn today for $65M.
- IoGyn's flagship product, the Symphion System, is a hysteroscopic device used to remove intrauterine tissue like fibroids and polyps. It complements BSX's Genesys HTA System for abnormal uterine bleeding.
- The Symphion resects the uterine growth and then removes the tissue through its recirculating and filtering fluid management system via suction. This avoids the potential to spread rare cases of sarcoma which is a potential risk with morcellation systems.
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