Feature | November 08, 2012

Boston Scientific Acquires Vessix Vascular, Renal Denervation System

Company to strengthen hypertension program with acquisition of renal denervation technology

Boston Scientific Renal Denervation Vessix Vascular

November 8, 2012 — Boston Scientific Corp. is extending its reach into the renal denervation market by signing a definitive agreement to acquire Vessix Vascular Inc. Vessix Vascular has developed a catheter-based renal denervation system for the treatment of uncontrolled hypertension. The acquisition is expected to close by the end of November 2012.

"Hypertension is a major global healthcare challenge, affecting more than one billion people worldwide," said Mike Mahoney, president and CEO at Boston Scientific. "Renal denervation represents a potential breakthrough therapy for the treatment of uncontrolled hypertension and is an important part of the Boston Scientific growth strategy. The acquisition of Vessix Vascular adds a second generation, highly differentiated technology to our hypertension strategy while accelerating our entry into what we expect to be a multi-billion dollar market by 2020."

Hypertension is the leading attributable cause of death worldwide. Despite the widespread availability of antihypertensive medications, the blood pressure of many patients remains high and uncontrolled. Renal denervation is an emerging, catheter-based therapy for medication-resistant hypertension that uses radiofrequency energy to disrupt the renal sympathetic nerves whose hyperactivity leads to uncontrolled high blood pressure. Renal denervation has been demonstrated in published clinical studies to significantly reduce systolic blood pressure.

The Vessix Vascular V2 Renal Denervation System has received CE mark in Europe and TGA approval in Australia. Vessix Vascular has initiated the Reduce-HTN post-market surveillance study and expects to initiate a full launch of the product in CE mark countries in 2013.

"The Vessix System offers the potential for a significant step forward in the treatment of uncontrolled hypertension," said Horst Sievert, M.D., Ph.D., director of the CardioVascular Center Frankfurt, Sankt Katharinen Hospital, Frankfurt, Germany. "In my experience, the system offers ease of use, faster treatment times with decreased patient discomfort and an intuitive approach to renal denervation that leverages the expertise of the interventionalist with balloon catheter technology."

Upon completion of the acquisition, Vessix Vascular will become part of the Peripheral Interventions business at Boston Scientific. The portfolio of the business includes products that treat vascular system blockages in areas such as the carotid and renal arteries and the lower extremities.

"Physician response to the V2 Renal Denervation System has been outstanding," said Raymond W. Cohen, CEO at Vessix Vascular. "We are confident that the combination of the Vessix Vascular renal denervation technology with the Boston Scientific broad global clinical and commercial scale will result in a new standard for the treatment of uncontrolled hypertension."

The agreement calls for an upfront payment of $125 million, plus additional clinical- and sales-based milestones aggregating a maximum of $300 million over the period between 2013 and 2017. Boston Scientific currently expects the net impact of this transaction on adjusted earnings per share to be immaterial for years 2013 and 2014 and break-even to accretive thereafter, and more dilutive on a GAAP basis as a result of acquisition-related net charges and amortization, which will be determined during the fourth quarter.

The V2 Renal Denervation System is an investigational device and not available for use or sale in the United States.

For more information: www.bostonscientific.com

Related Content

FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its...
Cook Medical Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments
News | Cath Lab | March 20, 2019
March 20, 2019 — Cook Medical is recalling one lot of its...
DABRA Excimer Laser System Demonstrates Success in Treating PAD
News | Cath Lab | February 27, 2019
Ra Medical Systems Inc. announced a 98 percent success rate in the results from a 52-patient study using the company’s...
Edwards Lifesciences Recalls Swan-Ganz hemodynamic catheters.
Feature | Cath Lab | February 06, 2019
Edwards Lifesciences is recalling its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufa
Scientists Discover New Heart Attack Repair Pathway

A macrophage immune cell, with a dead cell (pink) that has been eaten, and a mitochondrion (green) between the dead cell and the nucleus. The study’s findings indicate that what the macrophage eats is taken up by the mitochondrion, which in turn communicates with the nucleus to activate the macrophage to promote tissue repair. Image courtesy of Northwestern Medicine.

News | Cath Lab | January 30, 2019
Northwestern Medicine scientists have discovered a novel signaling pathway that promotes healing after a heart attack....
Shockwave Initiates U.S. Pivotal Study for Coronary Intravascular Lithotripsy
News | Cath Lab | January 16, 2019
Shockwave Medical Inc. has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE...
Overlay Init