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Boston Scientific Announces CE Mark For MRI Labeling Of Emblem™ S-ICD Systems

European Approval Granted for Third-Generation System and All Previously Implanted, Second-Generation Systems

The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.

In Europe, the EMBLEM MRI S-ICD System joins the growing family of ImageReady™ MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.

“These approvals give reassurance to physicians and their patients that they have access to any future MR scan needs, and underscores the Boston Scientific commitment to gain MR-conditional labeling on high-voltage devices that are being implanted today,” said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. “Further, the EMBLEM S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels.”

The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

The company is actively pursuing U.S. Food and Drug Administration (FDA) approval of the EMBLEM MRI S-ICD System as well as MR-conditional labeling for previously implanted EMBLEM S-ICD Systems. Additionally, the global ENABLE MRI study, initiated earlier this year, is intended to support FDA approval for MR-conditional labeling across the company’s currently approved ICD and cardiac resynchronization therapy systems.

For more information on the EMBLEM S-ICD Systems visit www.sicdsystem.com.

In the U.S., the EMBLEM MRI S-ICD System is not available for sale.

 

Boston Scientific Launches the AXIOS™ Stent and Electrocautery Enhanced Delivery System

The AXIOS System has been cleared for endoscopic management of pancreatic pseudocysts and certain types of walled-off pancreatic necrosis.1 These conditions represent two types of pancreatic fluid collections (PFCs) that occur in 5-16 percent of patients with acute pancreatitis and 20-40 percent of patients with chronic pancreatitis.2 While some of these PFCs are asymptomatic and self-resolving, others cause severe symptoms and require treatment.

Under endoscopic ultrasound (EUS) guidance, a physician can utilize the AXIOS System electrocautery-enhanced catheter to gain access to the PFC and deploy the AXIOS stent which facilitates drainage of the PFC by creating a temporary channel between the PFC and the gastrointestinal tract. The large flanges on each end of the lumen-apposing stent reduce the risk of leakage and migration. The stent – which is MRI compatible, fully covered, and self-expanding – is the only removable metal stent in the U.S. indicated for PFC drainage.

Although symptomatic PFCs can also be treated surgically, surgery has been associated with high rates of morbidity (7–37 percent) and mortality (6 percent).2 Endoscopic solutions may offer a less invasive treatment option associated with shorter hospital stays, better physical and mental health of patients, as well as lower cost.3

“The AXIOS Stent and Electrocautery Enhanced Delivery System provide a simpler and faster treatment option for patients,” said Kenneth Binmoeller, M.D., California Pacific Medical Center, San Francisco, CA and the inventor of the AXIOS System. “We can now provide an endoscopic solution that provides immediate relief for these patients using one device in a single setting.”

“In our practice, the AXIOS System has improved the endoscopic treatment of PFCs and walled off necrosis,” said Todd Baron, M.D., professor of Medicine and director of Advanced Therapeutic Endoscopy, University of North Carolina Hospital, Chapel Hill, North Carolina. “The delivery system has improved our procedural efficiency by reducing procedure time and patient exposure to X-ray imaging. In addition, we believe that the large diameter stent design is helping to reduce the cost of care by decreasing hospital length of stay and the number of interventions needed to manage this complex disease.”

1 The walled-off necrosis indication for the AXIOS Stent and Electrocautery Enhanced Delivery System is for PFCs containing less than 30 percent dead tissue.
2 Safety and Efficacy of Endoscopic Ultrasound-Guided Drainage of Pancreatic Fluid Collections With Lumen-Apposing Covered Self-Expanding Metal Stents. Shah RJ, Shah JN, Waxman I, Kowalski TE, Sanchez-Yague A, Nieto J, Brauer BC, Gaidhane M, Kahaleh M. Clin Gastroenterol and Hepatol 2014 Oct 5 http://www.ncbi.nlm.nih.gov/pubmed/25290534
3 Varadarajulu et al, Equal Efficacy of Endoscopic and Surgical Cystogastrostomy for Pancreatic Pseudocyst Drainage in a Randomized Trial. Gastroenterology 2013; 145:

For more information, please visit the AXIOS™ System product page here. Or follow Boston Scientific Endoscopy on Twitter at @bsc_endoscopy.

Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/72234510-boston-scientific-axios-stent-and-delivery-system/

 

Boston Scientific Announces U.S. FDA Approval of Navigation-Enabled Ablation Catheters

New catheters and software enhancement expand capabilities of high-definition Rhythmia™ Mapping System.

MARLBOROUGH, Mass., May 3, 2016 /PRNewswire/ — Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for two catheters that can be used with the Rhythmia™ Mapping System. The IntellaNav™ XP and the IntellaNav MiFi™ XP navigation-enabled ablation catheters – designed to map and ablate – were approved to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart. These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market. Along with the immediate launch of the catheters, the company is also releasing a software enhancement for the Rhythmia Mapping System.

“By combining these new magnetic navigation-enabled catheters with our high-density, high-resolution Rhythmia Mapping System, we can create enhanced maps that help diagnose arrhythmias and improve guidance during cardiac ablation procedures,” said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. “With these approvals, we continue the expansion of our electrophysiology product offerings, further demonstrating our commitment to help electrophysiologists provide the highest quality of care for their patients.”

Unlike conventional cardiac mapping systems, the Rhythmia Mapping System rapidly and automatically generates three-dimensional images of any chamber of the heart to help diagnose, locate and treat the source of rhythm abnormality. The Software Version 1.4 mapping system update improves the speed and quality in which the images are acquired using a variety of therapeutic and diagnostic catheters, including the IntellaNav XP and IntellaNav MiFi XP catheters. The software update also provides advanced editing capabilities, allowing for detailed visual enhancements of the maps.

Both of the newly approved IntellaNav XP catheters feature magnetic sensors which track the location of the catheter while delivering radiofrequency energy into the heart muscle, creating heat to destroy a small area of the tissue responsible for the abnormal heart rhythm. The IntellaNav MiFi XP catheter also provides increased accuracy and signal clarity via mini-electrode technology which delivers a highly localized signal closely reflecting what is happening at the tip in real-time during the ablation procedure.

Boston Scientific Launches Next Generation SpyGlass™ DS Direct Visualization System

MARLBOROUGH, Mass., Feb. 26, 2015 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announces 510(k) clearance and the first cases of the SpyGlass DS Direct Visualization System used for cholangioscopy and pancreatoscopy procedures. Built on the technology of the original SpyGlass System, the new SpyGlass DS System is designed to optimize procedural efficiency and productivity with improved ease of setup, ease of use and image quality.

More than one million people worldwide undergo endoscopic retrograde cholangiopancreatography (ERCP) procedures each year to diagnose and treat diseases and conditions of the liver, gallbladder, pancreas and bile ducts.1 In the event that x-ray imaging is not sufficient to make a definitive diagnosis or therapeutic intervention requires direct visualization, cholangioscopy or pancreatoscopy may be performed. Cholangioscopy is the examination of the bile ducts using an endoscope to enable direct visualization of the biliary tree during ERCP while pancreatoscopy is the examination of the pancreatic ducts. Direct visualization of the bile and pancreatic ducts during ERCP can help obtain biopsy specimens, lead to the diagnosis of abnormalities, and guide stone therapy.2

“I’m extremely pleased with the overall functionality of the new SpyGlass DS System,” said Robert Hawes, M.D., FASGE, The Center for Interventional Endoscopy at Florida Hospital Orlando. “It was quick and easy to set up (‘plug and play’), the image quality and stability excellent and the four-way tip deflection intuitive. The system now enables endoscopists with ERCP expertise to perform cholangioscopy with or without intervention. My expectation is that this technology will increase our ability to diagnose and treat pancreatobiliary diseases and reduce the number of repeat ERCPs.”

Launched in 2007, the original SpyGlass System helped re-establish cholangioscopy and pancreatoscopy as a valuable diagnostic and therapeutic procedure by allowing a single physician to perform the procedure as well as guide devices to examine, diagnose and treat conditions such as gallstones and suspected malignancies of the biliary tree and pancreas. The new SpyGlass DS System builds on this technology with enhanced features to further improve visualization and help simplify the procedure. The system consists of a fully integrated SpyScope™ DS Access and Delivery Catheter, and a single-use scope to eliminate probe reprocessing and image degradation over multiple uses. The integrated digital sensor provides superior imaging, far greater resolution and a 60 percent wider field of view than the first generation system. In addition, the SpyGlass DS System offers physicians an integrated controller that fits on a standard ERCP cart for improved accessibility and ‘plug and play’ setup, helping to reduce procedure time.

“Early detection is critical to improving outcomes in patients suffering from difficult pancreatico-biliary diseases, such as pancreatic cancer,” said David Pierce, senior vice president and president, Endoscopy, Boston Scientific. “The new SpyGlass DS System can be performed as an extension of any ERCP procedure, enabling physicians to diagnose and treat more of their patients effectively and efficiently. Boston Scientific is proud to bring single-operator cholangioscopy to a new level of treatment.”

 

Boston Scientific Announces Definitive Agreement To Acquire AMS’ Urology Portfolio

MARLBOROUGH, Mass., March 2, 2015 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced that it has entered into a definitive agreement with Endo International plc (NASDAQ: ENDP) (TSX: ENL) to acquire the American Medical Systems urology portfolio, which includes the Men’s Health and Prostate Health businesses, for $1.6 billion in up-front cash and a potential additional $50 million milestone based on 2016 sales. The company expects to close the transaction in the third quarter of 2015, subject to customary closing conditions.

Upon completion of the transaction, the AMS Men’s Health and Prostate Health businesses will become part of Boston Scientific Urology and Women’s Health. The acquisition encompasses the AMS product portfolio for treating urologic conditions, including benign prostatic hyperplasia (BPH), male stress urinary incontinence and erectile dysfunction. These technologies complement Boston Scientific’s strong kidney stone, pelvic organ prolapse, female stress urinary incontinence and abnormal uterine bleeding treatment portfolios, and together, will provide customers with a comprehensive urology, urogynecology and gynecologic surgery portfolio. The AMS women’s health business for treating pelvic organ prolapse and female stress urinary incontinence is not included in the transaction.

“We believe this strategic acquisition will strengthen Boston Scientific’s global leadership in the urology device category while delivering a strong return to our investors,” said Mike Mahoney, president and chief executive officer of Boston Scientific. “The combination of Boston Scientific’s Urology and Women’s Health and AMS’ urology portfolios will create a business with nearly $1 billion in annual sales and enable significant synergies and strong future growth prospects through portfolio innovation and international market expansion. We look forward to serving customers and impacting patient care in ways that could not be realized by either company alone.”

Based in Minnetonka, Minn., the AMS Men’s Health and Prostate Health businesses include approximately 800 employees worldwide, and generated 2014 sales of approximately $400 millionand adjusted operating income of approximately $130 million, excluding amortization and certain allocated expenses. GAAP operating income, including amortization and certain allocated expenses, was approximately $60 million[1] in 2014. Upon closing, Boston Scientific will acquire a diverse portfolio, including:

  • The minimally invasive  GreenLight XPS™ and HPS™ Laser Therapy Systems for treating BPH, a non-cancerous enlargement of the prostate and one of the most common diseases among aging men.[2] Worldwide, BPH affects approximately 90 million men over 50 each year, with over 25 million suffering from moderate to severe symptoms.[3-6] The GreenLight XPS System is a leading BPH laser treatment technology.
  • The AMS 800™ Urinary Control System for treating stress urinary incontinence, a condition affecting an estimated 12 million men worldwide, with 70-80% of cases secondary to prostate cancer treatment.[7-12] AMS is a leading provider of male incontinence treatment devices.
  • The AMS 700™ Inflatable Penile Prosthesis for treating erectile dysfunction, a condition affecting more than 200 million men annually worldwide, with nearly 50% of men over 60 suffering from moderate to severe symptoms.[6,13] AMS is a leading provider of erectile restoration devices.

Commenting on the agreement, Karen Prange, senior vice president and president of Urology and Women’s Health at Boston Scientific Corporation said, “Urology is an exciting area with ample opportunities to address unmet medical needs. This acquisition is intended to bring together the global talent, expertise and product portfolios of both companies to drive continued healthcare advancements and value for our customers.  Together, our strong leadership and innovative solutions can help physicians provide relief, restore bodily functions and enable millions of patients worldwide to regain control of their lives.”

The acquisition is expected to result in annual pre-tax synergies in excess of $50 million by the end of 2018.  On an adjusted basis, the transaction is expected to be breakeven to adjusted earnings per share in 2015, accretive by at least 3 cents in 2016, approximately 7 cents in 2017, and increasingly accretive thereafter. The transaction is expected to be less accretive (or dilutive, as the case may be) on a GAAP basis 2015 through 2017, due to amortization expense and transaction and integration costs.

The acquisition is being structured as an asset purchase for tax purposes. Boston Scientific intends to finance the acquisition through a combination of existing and newly committed credit facilities. J.P. Morgan Securities LLC acted as financial advisor to Boston Scientific.

New data demonstrate SYNERGY™ bioabsorbable polymer stent meets key performance

EVOLVE II Trial Represents the First Successful U.S. Pivotal Trial of a Bioabsorbable Polymer Stent

In the first successful U.S. pivotal trial of a bioabsorbable polymer stent, the Boston Scientific (NYSE: BSX) SYNERGY™ Everolimus-Eluting Bioabsorbable Polymer Platinum Chromium Coronary Stent System met its primary endpoint in this non-inferiority study, which evaluated the one-year rate of target lesion failure (TLF).

Additionally, favorable rates for key secondary endpoints were observed with the SYNERGY Stent. Dean Kereiakes, M.D., F.A.C.C., F.S.C.A.I., the principal investigator for the EVOLVE II Trial, presented the study results today in a Late Breaking Clinical Trial session at the American Heart Association Scientific Session 2014 in Chicago.

Key findings for the SYNERGY Stent from the EVOLVE II Trial include the following:

  • At 12 months, the TLF rate was 6.4 percent per protocol (p=0.0003 for non-inferiority) and 6.7 percent for intent-to-treat (p=0.0005 for non-inferiority).
  • Stent Thrombosis (ST) was rare, with Definite or Probable ST occurring in only 0.4 percent of patients through one year. No Definite ST occurred after 24 hours.

“The one-year data from the EVOLVE II Trial, particularly the exceptionally low stent thrombosis rate, are encouraging because this is a complex patient population,” said Kereiakes, who is medical director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center, Cincinnati.“Having a bioabsorbable polymer stent with this type of performance is important to physicians and health care systems. In addition, there is great enthusiasm for a product that is very deliverable and user-friendly. From an operator perspective, the SYNERGY Stent makes cases easier.”

The EVOLVE II Trial is a global, multi-center, randomized, single-blind, non-inferiority pivotal trial designed to evaluate the performance of the SYNERGY Stent System compared to the durable polymer PROMUS Element™ Plus Drug-Eluting Stent (DES) System. The trial enrolled 1,684 patients in 125 sites worldwide, including the U.S., Canada, Europe, Australia, New Zealand, Japan and Singapore. Patients demonstrated both clinical and angiographic complexity to a degree not observed in prior U.S. pivotal trials for DES. More than 25 percent of patients had non-ST elevation myocardial infarction (NSTEMI) and approximately 75 percent of patients had AHA/ACC class B2 or C coronary lesions.

The EVOLVE II Trial is part of a rigorous clinical program designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the SYNERGY Stent.

“The EVOLVE II Trial adds to our growing body of knowledge about the promising SYNERGY Bioabsorbable Polymer Stent, which is designed to provide early healing and freedom from long-term polymer exposure,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “It also supports key findings from the EVOLVE FHU study, where data through three-years demonstrate excellent long-term outcomes.”

New data demonstrate long-term low back pain relief with Precision Spectra™ SCS System

Significant Relief Achieved Using Advanced Illumina™ 3D Programming Software

New retrospective data evaluating the Boston Scientific Corporation (NYSE: BSX) Precision Spectra Spinal Cord Stimulator (SCS) System demonstrate that the device provided sustained, highly significant relief of low back pain 12 months after implantation. Results from the PRO Study are being presented this weekend at the 18th North American Neuromodulation Society (NANS) meeting in Las Vegas.

The outcomes review of 213 patients at 13 centers focuses on patients with chronic pain and chronic low back pain who are receiving treatment with the Precision Spectra SCS System. The system’s Illumina™ 3D Software, an anatomy-driven computer model designed for simple point-and-click pain targeting, helps to address a key challenge in long term back pain relief: stimulating the neural target without stimulating undesired areas.

At 12 months post-implantation, results include:

  • Sustained and significant reduction in overall pain measured on the 0-10 numeric rating scale (NRS) was reported, from an average baseline score of 7.17, to an average score of 2.96 at 12 months post-implantation (N= 178).
  • In patients with only low back pain (N= 73), a sustained and significant reduction of low back pain (measured on the 0-10 NRS scale) was reported, from an average baseline score of7.21 to an average of 3.17 at 12 months post-implantation.
  • In patients with severe low back pain (N= 41, baseline score of 8 or greater measured on the 0-10 NRS scale), sustained and significant reduction in pain was reported, from an average score of 8.60 at baseline to 2.87 at 12 months post-implantation.

This cohort will be followed through the 24-month interval.

“Treating low back pain has been challenging because so many therapies have had mixed results,” said Salim Hayek, M.D., Ph.D., chief, Division of Pain Medicine at University Hospitals of Cleveland and lead study investigator. “These results demonstrate that the Precision Spectra System can provide effective, long-term relief for patients suffering from this difficult to treat condition.”

“When designing the next-generation Precision Spectra SCS System, we included new, innovative technologies with the goal of treating low back pain more effectively,” said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. “This long-term, ‘real-world’ study reflects our continuing commitment to advancing the science of pain relief to help achieve better outcomes for patients with chronic pain.”

Together with the clinical data presented at NANS, additional presentations will describe an advanced research program of investigational studies of Boston Scientific SCS systems. These studies include ACCELERATE, a prospective multicenter trial evaluating conventional high-rate (10 kHz) spinal cord stimulation in the management of chronic, intractable pain, and WHISPER, a prospective multicenter trial evaluating the use of sub-perception multiple independent current control (MICC) SCS at up to 1.2 kHz.

About Chronic Pain

Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients; without relief, or the hope for relief, many patients lose the ability to sleep, work and function normally. In particular, conventional spinal cord stimulator therapy can be effective in treating low back pain but not all patients get optimal relief. As a result, there is a continuing need for new therapies and technologies to meet this very specific pain area.

About the Precision Spectra SCS System

Recently, Popular Mechanics magazine awarded the Precision Spectra System the 2014 “Breakthrough Award” in the field of medical devices for its innovation in meeting the needs of patients with chronic pain. The Precision Spectra SCS System is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts, which is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain.

Prior to the release of the Precision Spectra SCS System, SCS systems offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of a single lead. Additional lead ports give physicians more flexibility to cover their patients’ pain at the time of implant and more flexibility to adapt to changing pain patterns in the future. With more contacts, the Precision Spectra SCS System also offers more coverage of the spinal cord for the management of chronic pain.

The upgradeable Precision Spectra SCS System is designed to improve pain relief using the innovative and highly advanced Illumina 3D Software, a three dimensional anatomy-driven computer model. A key challenge in SCS therapy is stimulating the neural target without stimulating undesired areas. By taking into account the conductivity of 3D anatomical structures and physician placement of the SCS leads, the Illumina 3D Software is designed for simple point-and-click pain targeting.