Press Releases

InterValve Named as One of Ten Companies to Keep an Eye on by Medical Design & Outsourcing


Read the article here. company / news / 6.23.2016

Initial Findings Using the V8 Hourglass-Shaped Valvuloplasty Balloon for Postdilatation in Treating Paravalvular Leaks Associated with Transcatheter Self-Expanding Aortic Valve Prosthesis


Read the article here. company / news / 3.6.2016

Maquet Medical Systems USA Entering Exclusive US Distribution Agreement for InterValve Inc.'s V8™ Aortic Valvuloplasty Balloon Catheter Utilized in Transcatheter Aortic Valve Replacement (TAVR) Procedures

WAYNE, N.J., Jan. 23, 2015 -- Maquet Medical Systems USA announced today an agreement to serve as the exclusive US distributor of InterValve Inc.'s V8™ Aortic Valvuloplasty Balloon Catheter. The V8 catheter is designed to be used in stand-alone balloon aortic valvuloplasty (BAV) and pre-dilatation during transcatheter aortic valve replacement (TAVR) procedures. Maquet's sales representatives in the United States will begin selling the V8 catheter during the first quarter of 2015.


The V8 balloon catheter is designed to inflate and deflate rapidly to reduce the duration of blood flow obstruction across the valve and features a "figure-8" shape balloon that enables the bulbs at either end of the balloon to "lock" into either side of the aortic annulus. This design has the potential to reduce the risk of balloon movement during dilatation. The V8 is the first ever valvuloplasty catheter that maintains the figure-8 shape throughout inflation which allows for leaflet hyper-extension, to create maximum valve area opening, without increasing the risk of over-stretching the annulus. The product received 510(k) clearance in February 2014.


"Stand-alone balloon aortic valvuloplasty and pre-dilatation during transcatheter aortic valve replacement procedures have been limited today by the use of dated, conventional balloon technologies," said, Mark Ungs, CEO of InterValve, Inc. "Our V8 balloon catheter's figure-8 shape enables it to lock in at the annulus and beneficially hyper-extend the leaflets in a way conventional balloons can't. We look forward to this partnership with Maquet."


Raoul Quintero, President and CEO Maquet North America, said, "We're seeing our customers look to BAV and TAVR as alternatives to surgical aortic valve replacement. In particular, technology improvements, operator and team experience, and continued research have resulted in increased interest and growth in transcatheter aortic valve replacement. We're excited to be able to offer the V8 catheter as part of our mission to support our customers in delivering the highest standards of care."


ABOUT MAQUET
Maquet, a trusted partner for hospitals and physicians for more than 175 years, is a global leader in medical systems. The company offers innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital - including the operating room (OR), hybrid OR/cath lab, and intensive care unit (ICU) - as well as intra- and inter-hospital patient transport. Additionally, Maquet develops intelligent and sustainable room concepts that exceed the expectations of modern hospitals, working in close cooperation with customers, production engineers and architects to integrate high quality products and services.


Headquartered in Rastatt, Germany, Maquet is the largest subsidiary of the publicly listed Getinge Group AB of Sweden. Maquet generated about 1.54 billion Euros in 2013, representing more than half of the Getinge Group's annual revenue of 2.9 billion Euros. Maquet has 6,550 employees and provides 40 international sales and service organizations, as well as a network of more than 300 sales partners. For more information, please visit www.maquet.com.


ABOUT INTERVALVE, INC. InterValve Inc. is headquartered in Minneapolis, Minnesota. The company is dedicated to advancing innovations in aortic valvuloplasty balloon catheter design that improve procedure safety and efficacy.


For More Information Contact:
Mr. Mark Ungs
Chief Executive Officer
InterValve, Inc.
952-303-3539

company / news / 1.23.2015

Oxford Finance Closes $3 Million Debt Facility with InterValve

ALEXANDRIA, Va., Jan. 21, 2015-- Oxford Finance LLC ("Oxford"), a specialty finance firm that provides senior debt to life sciences and healthcare services companies, today announced the closing of a $3 million senior secured term loan agreement with InterValve, Inc. ("InterValve"). Proceeds of the loan will be used for product line expansion and the ongoing commericialization of the company's lead product, the V8™ Aortic Valvuloplasty Balloon catheter. "InterValve's aortic valve dilation device is technologically innovative and has been proven to be a safe and effective solution for treating patients with calcific aortic stenosis," said Christopher A. Herr, managing director for Oxford Finance. "We are pleased to provide financing to support the growth of the company and the advancement of InterValve's unique product."


"We are pleased to be partnering with Oxford," said Mark Ungs, chief executive officer of InterValve. "This funding will allow us to continue our commercial and development efforts."


ABOUT OXFORD FINANCE LLC Oxford Finance is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to its clients, enabling these companies to maximize their equity by leveraging their assets. In recent years, Oxford has originated over $2 billion in loans, with lines of credit ranging from $500 thousand to $75 million. Oxford is headquartered in Alexandria, Virginia, with additional offices in California, Massachusetts, Illinois and North Carolina. For more information visit www.oxfordfinance.com.


ABOUT INTERVALVE, INC. InterValve Inc. is headquartered in Minneapolis, Minnesota. The company is dedicated to advancing innovations in aortic valvuloplasty balloon catheter design that improve procedure safety and efficacy.


For More Information Contact:
Mr. Mark Ungs
Chief Executive Officer
InterValve, Inc.
952-303-3539

company / news / 1.21.2015

InterValve Inc.'s V8™ Aortic Valvuloplasty Balloon Catheter Used With Live 3D Transesophageal Echocardiography to Guide TAVR Procedure

MINNEAPOLIS - October 24, 2014 - The V8™ Balloon Aortic Valvuloplasty catheter from InterValve Inc., has been used successfully to dilate the aortic valve annulus during a Trans-Aortic Valve Replacement (TAVR) procedure guided by live 3D transesophogeal echocardiography (TEE), with minimal use of fluoroscopy.

The pre-taped case was presented by George Gellert, MD, Medical Director of the Interventional Echocardiography, Structural Heart Program, at Cavanagh Heart Center, Banner Good Samaritan Medical Center.


Compromised renal function is not uncommon for patients undergoing a TAVR procedure which makes some of them intolerant of the radiopaque dyes used to guide the procedure. In order to avoid the use of dyes, the team at Banner Good Samaritan Hospital performed what is believed to be the first TAVR procedure guided exclusively by echocardiography, using zero contrast and minimal fluoroscopy. In order to visualize during BAV where the aortic valve annulus was located, the V8 balloon aortic valvuloplasty catheter was used to dilate the native valve.


"Identification and visualization of the aortic annulus during a TAVR procedure is difficult. Because of the V8 balloon's unique shape it predictably self-centers and stabilizes itself on the annulus upon inflation, which confirms our assessment of the annulus location by echocardiography and prevents balloon slipping from the annulus," stated Dr. Gellert after the successful procedure.


Mark Ungs, CEO of InterValve, Inc. was pleased that the V8 catheter had a positive role in the procedure, stating "Regardless of imaging technology used by the operator, finding and safely dilating the annulus can be difficult in preparation for delivery of a prosthetic valve. Our V8 balloon catheter's figure-8 shape enables it to lock in at the annulus and beneficially hyper-extend the leaflets in a way conventional balloons can't".


One of the images presented by Dr. Gellert can be found here.


ABOUT BALLOON AORTIC VALVULOPLASTY (BAV) AND TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) Calcific aortic stenosis (AS) is the most common cause of acquired valvular heart disease in the Western world with substantial morbidity and mortality. While patients can survive for years with asymptomatic AS, the prognosis following symptom onset is quite poor without intervention. Surgical aortic valve replacement is the definitive treatment for AS with universally recognized symptomatic relief and almost full restoration of age-adjusted life expectancy. However, a significant number of symptomatic AS patients forgo surgical valve replacement due to risk of complications.


In a BAV procedure a balloon catheter is placed across the valve and the leaflets are dilated with balloon inflation which can provide immediate symptomatic relief.


TAVR is a new catheter based procedure that delivers a prosthetic valve via the femoral artery, but sometimes transapically. In a TAVR procedure a balloon catheter, such as the V8, is first delivered across the native valve to pre-dilate the valve leaflets before the prosthetic valve is delivered and implanted.


Both procedures can be compromised by dilation balloon slippage during inflation, and damage to the valvular annulus by over distension.


ABOUT INTERVALVE, INC. InterValve Inc. is headquartered in Minneapolis, Minnesota. The company is dedicated to advancing innovations in aortic valvuloplasty balloon catheter design that improve procedure safety and efficacy.


For More Information Contact:
Mr. Mark Ungs
Chief Executive Officer
InterValve, Inc.
952-303-3539

company / news / 11.17.2014

INTERVALVE INC. ANNOUNCES NEW FINANCING

MINNEAPOLIS - August 7, 2014 - InterValve Inc., an early stage medical device company dedicated to advancing innovations in aortic valvuloplasty balloon catheter design, announced today that it has successfully closed another round of financing. Money raised will be used for global commercialization and development of new platforms.


InterValve's current product, the V8® catheter is designed to be used in stand-alone balloon aortic valvuloplasty (BAV), and pre-dilation during transcatheter aortic valve replacement (TAVR) procedures. The V8 received CE Mark and FDA market clearance earlier this year.


The V8 is the first ever BAV catheter that features a "figure-8" shaped balloon that maintains its shape throughout inflation allowing for valve leaflet hyper-extension and maximal valve area opening, while avoiding annulus over distension. The balloon shape also "locks" into the valve anatomy reducing the risk of balloon movement during dilatation. Lastly, the catheter is designed to inflate and deflate rapidly to reduce the duration of blood flow obstruction across the valve.


The company will exhibit at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, DC September 14 - 17 where use of the V8 balloon catheter is scheduled for a taped clinical case. TCT is the world's largest and most important educational meeting specializing in interventional cardiovascular medicine.


ABOUT BALLOON AORTIC VALVULOPLASTY (BAV) AND TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) Calcific aortic stenosis (AS) is the most common cause of acquired valvular heart disease in the Western world with substantial morbidity and mortality. While patients can survive for years with asymptomatic AS, the prognosis following symptom onset is quite poor without intervention. Surgical aortic valve replacement is the definitive treatment for AS with universally recognized symptomatic relief and almost full restoration of age-adjusted life expectancy. However, a significant number of symptomatic AS patients forgo surgical valve replacement due to risk of complications.


In a BAV procedure a balloon catheter is placed across the valve and the leaflets are dilated with balloon inflation which can provide immediate symptomatic relief.


TAVR is a new catheter based procedure that delivers a prosthetic valve via the femoral artery, but sometimes transapically. In a TAVR procedure a balloon catheter, such as the V8, is first delivered across the native valve to pre-dilate the valve leaflets before the prosthetic valve is delivered and implanted.


Both procedures can be compromised by dilation balloon slippage during inflation, and damage to the valvular annulus by over distension.


ABOUT INTERVALVE, INC. InterValve Inc. is headquartered in Minneapolis, Minnesota. The company is dedicated to advancing innovations in aortic valvuloplasty balloon catheter design that improve procedure safety and efficacy.


For More Information Contact:
Mr. Mark Ungs
Chief Executive Officer
InterValve, Inc.
952-303-3539

company / news / 8.7.2014

INTERVALVE INC. RECEIVES 510(k) CLEARANCE IN THE UNITED STATES FOR THE V8™ AORTIC VALVULOPLASTY BALLOON CATHETER

MINNEAPOLIS - April 26, 2013 - InterValve Inc., an early stage medical device company dedicated to advancing innovations in aortic valvuloplasty balloon catheter design, announced today that it has received 510(k) clearance to market the new V8™ Aortic Valvuloplasty Balloon Catheter in the United States.


The V8™ catheter is designed to be used in stand-alone balloon aortic valvuloplasty (BAV), and pre-dilation during transcatheter aortic valve replacement (TAVR) procedures.


"These procedures are limited today by the use of dated, conventional balloon technologies. The shape and material properties of the V8™ balloon catheter are designed to enhance both procedures through reduction in balloon movement and optimized leaflet expansion without over distention of the annulus," said Mark Ungs, Chief Executive Officer of InterValve.


The balloon catheter features a "figure-8" shape balloon that enables the bulbs at either end of the balloon to "lock" into either side of the aortic annulus. This design has the potential to reduce the risk of balloon movement during dilatation, thereby reducing procedure and ischemic time.


The non-compliant material maintains the figure-8 shape throughout inflation which allows for leaflet hyper-extension, to create maximum valve area opening, without increasing the risk of over-stretching the annulus.


Lastly, the catheter is designed to inflate and deflate rapidly to reduce the duration of blood flow obstruction across the valve.


ABOUT BALLOON AORTIC VALVULOPLASTY (BAV) AND TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) Calcific aortic stenosis (AS) is the most common cause of acquired valvular heart disease in the Western world with substantial morbidity and mortality. While patients can survive for years with asymptomatic AS, the prognosis following symptom onset is quite poor without intervention. Surgical aortic valve replacement is the definitive treatment for AS with universally recognized symptomatic relief and almost full restoration of age-adjusted life expectancy. However, a significant number of symptomatic AS patients forgo surgical valve replacement due to risk of complications.


In a BAV procedure a balloon catheter is placed across the valve and the leaflets are dilated with balloon inflation. This procedure can provide immediate symptom relief, but is not a long term durable solution as the leaflets tend to re-stenose.


TAVR is a new catheter based procedure that delivers a prosthetic valve via the femoral artery, but sometimes transapically. In a TAVR procedure a balloon catheter is first delivered across the native valve to pre-dilate the valve leaflets before the prosthetic valve is delivered and implanted.


Both procedures can be compromised by dilation balloon slippage during inflation, and damage to the valvular annulus by over distension.


ABOUT INTERVALVE, INC. InterValve Inc. is headquartered in Minneapolis, Minnesota. The company is dedicated to advancing innovations in aortic valvuloplasty balloon catheter design that improve procedure safety and efficacy.

For More Information Contact:
Mr. Mark Ungs
Chief Executive Officer
InterValve, Inc.
952-303-3539

company / news / 4.26.2013

INTERVALVE INC. COMPLETES FIRST-IN-MAN STUDY FOR THE V8™ AORTIC VALVULOPLASTY BALLOON CATHETER

MINNEAPOLIS - April 8, 2013 - InterValve Inc., an early stage medical device company dedicated to advancing innovations in aortic valvuloplasty balloon catheter design, announced today that it has successfully completed its initial study of the V8™ Aortic Valvuloplasty Balloon Catheter.


A total of four patients were enrolled in the study conducted by Dr. Adrian Ebner of Asuncion, Paraguay. All patients received successful dilation of the aortic valve.


 "The V8™ Balloon Catheter proved in these initial cases that it can safely and effectively dilate the aortic valve, and when compared to conventional balloon catheters we experienced first-hand reduction in balloon movement during balloon inflation," said Dr. Ebner.


The V8™ catheter is designed to be used in stand-alone balloon aortic valvuloplasty (BAV), and pre-dilation during transcatheter aortic valve replacement (TAVR) procedures.


 "We are very pleased with the results of this important initial study of the V8™ Aortic Valvuloplasty Balloon Catheter. After years of development, it is very satisfying to see this catheter perform in patients as we originally envisioned," said Mark Ungs, Chief Executive Officer for the company.


ABOUT BALLOON AORTIC VALVULOPLASTY (BAV) AND TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)

Calcific aortic stenosis (AS) is the most common cause of acquired valvular heart disease in the Western world with substantial morbidity and mortality. While patients can survive for years with asymptomatic AS, the prognosis following symptom onset is quite poor without intervention. Surgical aortic valve replacement is the definitive treatment for AS with universally recognized symptomatic relief and almost full restoration of age-adjusted life expectancy. However, a significant number of symptomatic AS patients forgo surgical valve replacement due to risk of complications.


In a BAV procedure a balloon catheter is placed across the valve and the leaflets are dilated with balloon inflation. This procedure can provide immediate symptom relief, but is not a long term durable solution as the leaflets tend to re-stenose.


TAVR is a new catheter based procedure that delivers a prosthetic valve via the femoral artery, but sometimes transapically. In a TAVR procedure a balloon catheter is first delivered across the native valve to pre-dilate the valve leaflets before the prosthetic valve is delivered and implanted.


Both procedures can be compromised by balloon slippage during inflation, and damage to the valvular annulus by over distension.


ABOUT THE V8™ AORTIC VALVULOPLASTY BALLOON CATHETER

The V8™ balloon catheter is designed to address some of the concerns associated with BAV and TAVR pre-dilatation through its unique shape and material properties.


The balloon catheter features a "figure-8" balloon that enables the bulbs at either end of the balloon to "lock" into either side of the aortic annulus. This design has the potential to reduce the risk of balloon movement during dilatation, thereby reducing procedure and ischemic time.


The non-compliant material maintains the figure-8 shape throughout inflation which allows for leaflet hyper-extension, to create maximum valve area opening, without increasing the risk of over-stretching the annulus.


Lastly, the catheter is designed to inflate and deflate rapidly to reduce the duration of blood flow obstruction across the valve.


ABOUT INTERVALVE, INC.

InterValve Inc. is headquartered in Minneapolis, Minnesota. The company is dedicated to advancing innovations in aortic valvuloplasty balloon catheter design that improve procedure safety and efficacy.


company / news / 4.8.2013

InterValve raises $4.7 million, appoints two new members to the Board of Directors

InterValve, Inc., a privately held, medical device company developing a next generation aortic valvuloplasty balloon announced today the completion of a Series A financing.


A strategic investor led the $4.7 million round of financing joined by prominent local Minneapolis businessmen. The round includes the conversion of $680,000 of convertible notes.


"The Company is developing a proprietary aortic valvuloplasty balloon for the most exciting new market in cardiac device procedures. The capital raised will allow InterValve to advance its device into human evaluation," stated Mark Ungs, CEO of InterValve.


The Company also announced the appointment of Dr. Glen Nelson and Mr. Michael Berman to serve on the Company's Board of Directors.


"We are extremely excited and honored to welcome Glen and Mike to the Company's Board," stated Dr. Robert Van Tassel InterValve co-founder and member of the Board of Directors. "These two individuals combined bring over fifty years of medical device experience. Their operational expertise and industry relationships will be a tremendous asset for us," said Dr. Van Tassel.


Dr. Glen Nelson, is chairman of GDN Holdings, LLC (Aviation, Medical Products and Services). Prior to GDN Holdings, he was a director of Medtronic Inc. from 1980-2002 and was employed as Executive Vice President from 1986-1988 and subsequently Vice Chairman from 1988-2002; practiced surgery from 1969-1986 at Park Nicollet; was chairman, president and chief executive officer of the Park Nicollet Medical Center, a large multi-specialty group practice in Minneapolis from 1975-1986; also chairman of the board and chief executive officer of American MedCenters, Inc., from 1984-1986. Dr. Nelson is an Emeritus Clinical Professor of Surgery at the University of Minnesota.


Mr. Michael Berman is a medical device investor/entrepreneur who has co-founded 7 Medical Device companies and currently serves on the boards of 11 emerging medical device companies. From 1995-2000 Mr. Berman was the President of the Cardiology business of Boston Scientific.


Dr. Robert Van Tassel is a retired board certified cardiologist and served as a Senior Consultant in Cardiology at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis and a Clinical Professor of Medicine at the University of Minnesota. He is a founder of the Minneapolis Heart Institute and past President of the Minneapolis Heart Institute Foundation. Dr Van Tassel currently serves on the board of directors of the Minneapolis Heart Institute Foundation and is on the board of directors of numerous emerging medical device companies. He is a Principal in TriCardia Ventures and has been a founder of three medical device companies that have been successfully acquired.

company / news / 8.31.2011

InterValve announces its third patent issuance

InterValve announces the receipt of its third patent dated May 31, 2011 from the U.S. Patent and Trademark Office. In this issued patent, InterValve was awarded key device claims regarding a shaped balloon catheter for performing valvuloplasty and measuring the stretch diameter of the aortic annulus. Commenting on this event, Mark Ungs, CEO of InterValve, stated: "This latest patent confirms a significant addition of intellectual property to our portfolio and advances our effort to develop devices that promise to deliver meaningful clinical value to the emerging transcatheter aortic valve implant procedure."


"Acquiring a true diameter measurement of the aortic annulus is a crucial step for the transcatheter aortic valve implant procedure," stated Dr. Wes Pedersen, InterValve cofounder and an Interventional Cardiologist at the Minneapolis Heart Institute/Abbott Northwestern Hospital. "Incorrect diameter measurement can lead to a mismatch between the annulus structure and the percutaneous valve prostheses. Unfortunately, noninvasive annulus diameter measuring techniques have been shown to be imprecise in up to 30% of cases. A device that provides a true stretch diameter measurement of the aortic annulus using transcatheter techniques would be a significant procedural advancement."


"The emerging transcatheter aortic valve implantation procedure is perhaps the most exciting area of development in cardiology and InterValve is dedicated to developing devices that improve the procedure's safety and efficacy," stated Mark Ungs.

company / news / 5.31.2011

InterValve announces its second patent issuance

InterValve announces the receipt of its second Final Office Action dated April, 2010 from the U.S. Patent and Trademark Office. In this Final Office Action, InterValve was awarded key device claims regarding a shaped balloon catheter for performing valvuloplasty. Commenting on this event, Mark Ungs, CEO of InterValve, stated: "This latest Office Action confirms a significant addition of intellectual property to our portfolio that protects an hour-glass shaped balloon design."


"This shape has a number of clinical advantages," stated Dr. Wes Pedersen, InterValve cofounder and an Interventional Cardiologist at the Minneapolis Heart Institute/Abbott Northwestern Hospital. "It limits undesirable movement during inflation by locking into the patient's anatomy, and the larger diameter balloon ends enhance leaflet dilatation, while the smaller waist protects the valve annulus from excessive dilatation pressure which can lead to significant injury to the patient."


"The emerging transcatheter aortic valve implantation procedure is perhaps the most exciting area of development in cardiology and the InterValve device will enable it to be safer and more effective," stated Mark Ungs.

company / news / 4.6.2010

InterValve receives notice of allowance from the US Patent Office

InterValve announces the receipt of a Final Office Action dated August, 2009 from the U.S. Patent and Trademark Office. In this Final Office Action, InterValve was granted claims for an innovative balloon catheter design for performing aortic valvuloplasty. Commenting on this event, Mark Ungs, CEO of InterValve, stated that this Office Action is a major milestone for InterValve as a first step in building a complete portfolio of intellectual property for devices to treat aortic stenosis.

company / news / 9.10.2009