Boston Scientific Announces Acquisition of Cosman Medical

Boston Scientific announced that it has acquired Cosman Medical, Inc., a privately held Burlington, Mass. manufacturer of radiofrequency ablation (RFA) systems. The Cosman Medical team and products will become part of the Boston Scientific Neuromodulation business, which offers a range of Spinal Cord Stimulator (SCS) systems to treat patients with chronic pain, and Deep Brain Stimulation systems for the treatment of Parkinson's disease, dystonia and essential tremor.

"This acquisition is a natural extension of our current product portfolio and will help us provide physicians and patients more options to address chronic pain with non-opioid therapeutic treatments," said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. "The addition of the Cosman Medical product line, which is built on industry-leading technology and known for its high-quality, expands our capability to provide innovative solutions for the treatment of chronic pain."

One in three Americans suffer from chronic pain and more than 100 million people are partially or totally disabled by pain. In the United States, it is the number one cause of disability in adults.1,2 RFA is a versatile outpatient procedure with a more than 50-year track record of providing relief for patients with chronic pain. It works by applying heat to small areas of nerve tissue to interrupt pain signals. SCS works by sending electrical signals to the spinal cord, masking pain signals from reaching the brain. In the continuum of care for pain, RFA is typically used prior to SCS. While many patients with chronic pain find effective relief from RFA, others progress to SCS to manage pain.

"We are pleased to join the Boston Scientific team and help expand access to leading treatments for chronic pain," said Eric Cosman, Jr, PhD, scientific director, Cosman Medical. "This acquisition comes at a time when our society is recognizing the impact of relying extensively on opioids to treat pain and is looking for additional approaches. Our mutual commitment to innovation and quality will help us deliver solutions."

The expansion into RFA follows the recent Boston Scientific launch of the Precision Montage™ MRI Spinal Cord Stimulator (SCS) System which offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met. MultiWave™ Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. The launch expanded the suite of Boston Scientific products that leverage the Illumina 3D™ algorithm, a three-dimensional, anatomy-driven computer model designed for simple point-and-click pain targeting to support physicians in treating chronic pain. In addition to the new Precision Montage MRI SCS System, the portfolio includes the Precision Spectra™ System, which is designed to provide broad coverage for pain with 32 contacts, and the Precision Novi™ System, the smallest high-capacity non-rechargeable device.

Boston Scientific currently expects the net impact of this transaction on adjusted earnings per share to be break-even in 2016 and accretive thereafter and more dilutive on a GAAP basis as a result of acquisition-related net charges and amortization. Specific terms of the transaction were not disclosed.

A press release can be found from Boston Scientific website.

Boston Scientific Announces Acquisition of Cosman Medical

Boston Scientific Corporation announced that it has acquired Cosman Medical, Inc., a privately held Burlington, Mass. manufacturer of radiofrequency ablation (RFA) systems. The Cosman Medical team and products will become part of the Boston Scientific Neuromodulation business, which offers a range of Spinal Cord Stimulator (SCS) systems to treat patients with chronic pain, and Deep Brain Stimulation systems* for the treatment of Parkinson's disease, dystonia and essential tremor.

"This acquisition is a natural extension of our current product portfolio and will help us provide physicians and patients more options to address chronic pain with non-opioid therapeutic treatments," said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. "The addition of the Cosman Medical product line, which is built on industry-leading technology and known for its high-quality, expands our capability to provide innovative solutions for the treatment of chronic pain."

One in three Americans suffer from chronic pain and more than 100 million people are partially or totally disabled by pain. In the United States, it is the number one cause of disability in adults.1,2 RFA is a versatile outpatient procedure with a more than 50-year track record of providing relief for patients with chronic pain. It works by applying heat to small areas of nerve tissue to interrupt pain signals. SCS works by sending electrical signals to the spinal cord, masking pain signals from reaching the brain. In the continuum of care for pain, RFA is typically used prior to SCS. While many patients with chronic pain find effective relief from RFA, others progress to SCS to manage pain.

"We are pleased to join the Boston Scientific team and help expand access to leading treatments for chronic pain," said Eric Cosman, Jr, PhD, scientific director, Cosman Medical. "This acquisition comes at a time when our society is recognizing the impact of relying extensively on opioids to treat pain and is looking for additional approaches. Our mutual commitment to innovation and quality will help us deliver solutions."

The expansion into RFA follows the recent Boston Scientific launch of the Precision Montage™ MRI Spinal Cord Stimulator (SCS) System which offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met. MultiWave™ Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. The launch expanded the suite of Boston Scientific products that leverage the Illumina 3D™ algorithm, a three-dimensional, anatomy-driven computer model designed for simple point-and-click pain targeting to support physicians in treating chronic pain. In addition to the new Precision Montage MRI SCS System, the portfolio includes the Precision Spectra™ System, which is designed to provide broad coverage for pain with 32 contacts, and the Precision Novi™ System, the smallest high-capacity non-rechargeable device.

Boston Scientific currently expects the net impact of this transaction on adjusted earnings per share to be break-even in 2016 and accretive thereafter and more dilutive on a GAAP basis as a result of acquisition-related net charges and amortization. Specific terms of the transaction were not disclosed.

A press release can be found from Boston Scientific website.

FDA Approves MRI Spinal Cord Stimulator from Boston Scientific

Boston Scientific announced the launch of the Precision Montage MRI Spinal Cord Stimulator (SCS) System after receiving approval from the U.S. Food and Drug Administration. The Precision Montage System offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met.

More than 100 million Americans suffer from chronic pain, which can have a devastating impact on quality of life. Patients with pain sometimes experience a fluctuation in location, type and intensity of pain throughout the day or over time. The Precision Montage MRI SCS System allows patients to undergo a full-body MRI while benefiting from the pain relief of MultiWave Technology. MultiWave Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. In an analysis of registry information from 800 patients, it was determined that 72 percent used multiple waveforms to customize their therapy and optimize pain relief.

A press release can be found from Boston Scientific website by following this link.

Boston Scientific initiated global voluntary recall of Fetch™ 2 Aspiration Catheter

Boston Scientific has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. The U.S. Food and Drug Administration (FDA) classified the action as a Class 1 recall. This recall designation means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.

There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter. All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications. While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically. 

As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to this recall.

Fetch 2 Catheter UPNs

FETCH2 US 109400-001

FETCH2 OUS 109400-002

FETCH2 Canada 109400-003

FETCH2 Japan 109400-004

FETCH2 EU 109400-005

To get more Information, please visit Boston Scientific website by clicking here.