UPDATE: Vessix in hand, Boston Scientific targets Medtronic in high blood pressure market

Boston Scientific acquires Vessix

Boston Scientific (NYSE:BSX) is confident that it will be the 2nd player in the U.S. market for renal denervation, executives told MassDevice.com today, stressing their belief that the Vessix Vascular high blood pressure treatment acquired today is superior to competing offerings from arch-rivals Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ).

"We believe we’ll be 2nd to market with a highly differentiated technology, a true 2nd-generation device," Jeff Mirviss, president Boston’s peripheral interventions business," told MassDevice.com today.

Laguna Hills, Calif.-based Vessix makes the V2 renal denervation system. Boston Scientific agreed today to pay up to $425 million for Vessix, with a $125 million up-front payment and another $300 million in milestone payments out to 2017.

In renal denervation, the nerves lining the renal arteries, believed to play a role in high blood pressure (or hypertension), are ablated with radiofrequency energy. Dr. Keith Dawkins, global chief medical officer for Boston Scientific, told us that the procedure has proven safe and efficacious out to 3 years in clinical trials.

"The data from the interim analysis of the Vessix trial presented at TCT showed impressive reduction of both systolic pressure and diastolic pressure out to 6 months," Dawkins said.

Unlike Medtronic’s Symplicity device and its single electrode, the Vessix V2 system’s multiple electrodes fire simultaneously. St. Jude’s Enlightn device also features multiple electrodes, but they fire sequentially, not simultaneously. That means the Vessix device can accomplish the procedure in about 30 seconds, compared with up to 30 minutes for the other devices, Mirviss said.

The V2 device won CE Mark approval in the European Union in May and is also approved for the Australian market. That gives BSX a leg up in getting the device onto those markets, Mirviss said.

"That will give us an entree into literally dozens of companies around the world. We’ll be putting this into our vast distribution channel to maximize the impact of this therapy," he said. "In 2013 or early 2014, we expect to begin an [investigational device exemption] trial to work toward commercialization in the U.S. and other key geographies."

Dawkins said Boston Scientific’s internal renal denervation program will be subsumed into the Vessix operation, under the umbrella of Mirviss’ PI segment. The internal program gave BSX renal denervation knowledge that will stand it in good stead, Dawkins said.

"We’ve had an internal program for some time. We’ve learned a lot about renal denervation in general and done a lot of preclinical work. The opportunity for this, what we think is a truly differentiated product, was really too good to miss from the acquisition point of view," he said.

Several features add to that differentiation, Mirviss and Dawkins told us.

"It’s hypothesized that some of the non-responders with the Medtronic device was due to the fact that it’s uncertain that the ablation has actually occurred. This device provides direct, real-time feedback to the physician as to whether the electrodes are in contact with the vessel wall," Mirviss explained. "It also indicates whether the device is in a place it shouldn’t touch. For example in the osteum of the artery, the device will not turn on."

With reducing costs the new holy grail of healthcare, Mirviss and Dawkins said the V2 device could defray costs by reducing the incidence of the serious complications attendant to hypertension.

"Imagine a patient with very high blood pressure, uncontrolled with current medication. They are at a significantly higher risk of death, as well as a higher risk of adverse events like stroke, heart attack, heart failure and kidney failure," Mirviss said. "If we could delay or eliminate major events like strokes, heart failure or heart attacks, that will save the healthcare system a significant amount of dollars."

"You don’t have to reduce the stroke rate by very much to make a profound economic impact on healthcare costs," Dawkins added.

RSS From Medical Design & Outsourcing

  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]
  • MasterControl’s CEO talks EQMS software and new partnerships
    MasterControl offers a quality and compliance software that helps device companies speed time to market and improve their bottom lines. Under Jon’s leadership, the company has blossomed into a market leader and has a unique corporate culture that fosters growth, excellence and quality. In this podcast, MasterControl’s CEO, Jon Beckstrand, will discuss electronic quality management […]
  • BIT Group launches white label IVD solutions
    BIT Group has launched a product line of customizable IVD white label instruments. During recent years, BIT has invested capital and resources developing customizable, ready-to-use IVD systems to address a growing demand. “The IVD market is challenging for our clients,” said Marius Balger, CEO at BIT. “OEM’s must adhere to a growing number of evolving IVD […]
  • Toshiba expands line-up of ARM Cortex-M-based microcontrollers
    Toshiba announced that it has enhanced its current “TX Family” of ARM core-based microcontrollers and started to develop three series of microcontrollers, “TXZ0 series,” “TXZ3 series” and “TXZ4 series,” as part of the “TXZTM Family.” The TXZTM Family is a new collection of flash microcontrollers that support low-power consumption and high-speed operation for IoT and M2M […]
  • Parker Hannifin consolidates, layoffs ahead
    Parker Hannifin plans to consolidate a number of internal divisions, close 2 facilities and expand its Mexican operations, according to an internally distributed letter from Andy Ross, Parker’s engineered materials group president. The company has confirmed the letter was authentic, but has not disclosed how many employees will be affected by the new plans or […]
  • 3-phase current transducer from PEM delivers all-in-one convenience
    The new RCTrms 3-ph current transducer from Power Electronic Measurements (PEM) delivers a convenient, safe and accurate solution for measuring current in three phases. It features a thin, clip-around, flexible sensor coil and provides accurate true rms measurement with 4-20 mA or 0-5 V output, enabling simple installation with PLC’s, SCADA systems or automation equipment. […]
  • Safety alert: Recall on two IV solutions from Baxter
    Baxter International announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital and user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to […]

Leave a Reply