Developments

Cardiology & Cardiovascular Surgery

FDA Approves Endologix’ Powerlink-120 Stent Graft

The FDA has granted market approval for two models of Endologix’ Powerlink-120, both short body/short limb variants of the Powerlink endoluminal stent graft system for the minimally invasive treatment of abdominal aortic aneurysms (AAA). Endologix believes that that the two Powerlink-120 models will address 5%–10% of AAA patients currently excluded from treatment due to anatomical considerations. The company plans to market the new devices starting this month.

CryoCath Reports Positive AF Data

Promising data concerning CryoCath Technologies’ proprietary Arctic Front catheter to treat atrial fibrillation (AF) was presented at the German Cardiac Society’s 72nd annual conference in Mannheim, Germany last month. In one study, researchers reported acute data following ablation procedures on 39 patients. They reported that 100% of the cases were considered successful, with complete isolation of all pulmonary veins, of which 90% were isolated using only Arctic Front. In another study, there was a 100% success rate involving 45 patients who received ablation. In this study, results showed that there was complete electrical isolation of all pulmonary veins, of which approximately 70% were isolated using only Arctic Front. No stenosis, thrombosis, esophageal perforation or stroke was reported at either center.

ESTECH Launches Cobra Adhere XL for Cardiac Ablation

ESTECH introduced the Cobra Adhere XL, a new alternative for cardiac ablation, at the American Association for Thoracic Surgery’s annual meeting last month. A radio frequency device, the Cobra has been well-received by surgeons as a less invasive method of ablation therapy, requiring only a few minutes of time to deliver the treatment. In peer-reviewed studies conducted on atrial fibrillation patients, the Cobra technology has produced the highest ablation success rates. The ESTECH Cobra Adhere XL and the Cobra AFfirm have recently received FDA 510(k) marketing clearance. The Cobra Adhere surgical system received CE mark approval with an indication for treatment for atrial fibrillation. The Cobra AFfirm is the first radio frequency accessory to be indicated for the treatment of cardiac arrhythmias in the United States.

Innocoll Launches New CollaRx Gentamicine Implant

Innocoll has introduced a new version of its CollaRx Gentamicin surgical implant for use in cardiac surgery. A recently published clinical study involving 2,000 patients undergoing a sternotomy during cardiac surgery demonstrated that Innocoll’s Gentamicin surgical implant reduced the incidence of sternal wound infection by 54% when used as an adjunct to standard infection prophylaxis. The trial was a prospective, randomized clinical study performed at two hospitals in Sweden. The implant has been cited as being particularly useful when treating diabetics who are undergoing cardiac surgery because this patient group has a higher risk for surgical complications, including sternal wound infection.

Shelhigh’s SuperStentless Plus Heart Valve in U.S. Trials

Shelhigh’s SuperStentless Plus valve, constructed of bovine pericardium and porcine leaflets, has been undergoing clinical studies and shows promise as being more biocompatible and mechanically durable than any existing tissue valve. The valve has already been approved for use in Europe, where it has been used for nine years. One of the major advantages of tissue valves over mechanical valves is that patients are not required to take blood thinners for the rest of their lives. Although tissue valves deteriorate and calcify within a few years, no child or adult over age 80 has demonstrated tissue failure or calcification with the Shelhigh valve. The valves also grow normal endothelium after being implanted. Shelhigh estimates that the valve will be approved by the FDA in about one year.

FDA Approves St. Jude’s Merlin Programmer

The FDA has approved the market launch of St. Jude Medical’s Merlin patient care system, a programmer for use with implantable cardioverter defibrillators (ICDs) and pacemakers. The system is designed to help physicians more efficiently conduct tests, analyze therapeutic and diagnostic data, and program implanted devices. The Merlin is one of more than 20 new cardiac rhythm management products expected to be introduced this year by St. Jude Medical. Further FDA approvals for additional Merlin graphical user interface upgrades for ICDs are expected later this year. The system’s portability and ease of use, allows physicians to retrieve and analyze patient information during routine follow-up visits.

Medtronic Enters Heart-Lung Machine Market

Medtronic has received FDA clearance to market its Performer Cardiopulmonary Bypass System (CPB), an integrated, compact device capable of providing total support of the circulatory system during a variety of cardiac surgical procedures. The system offers all the functionality of existing systems but only occupies a 20-inch by 22-inch space, taking up significantly less operating room space. Cardiothoracic surgeon Michael Harostock of Wilkes-Barre General Hospital (Wilkes-Barre, Penn.) believes that the device is safer than traditional “heart-lung” consoles. More than 250 patients at this hospital have undergone surgery using the Medtronic CPB.

Endocrinology

MicroIslet’s Encapsulated Porcine Islets Show Promise in Primates

MicroIslet announced promising results from its preclinical studies, showing that minimally invasive transplantation of encapsulated porcine islets into diabetic primates resulted in significant and prolonged improvement of blood sugar, with reduced insulin use. These results were accomplished using MicroIslet’s proprietary encapsulation formulation, which is designed to sufficiently isolate the insulin-producing islets from the subjects’ immune systems to prevent their destruction as foreign tissues during the recorded survival period. The encapsulated islets also were able to receive necessary nutrients and oxygen from the bloodstream and release blood-glucose-modulating insulin into the bloodstream through the outer layers of the islet capsules.

Gynecology

Mentor Receives Approval for NovaSilk Synthetic Mesh

The FDA has granted Mentor marketing approval for its NovaSilk synthetic mesh product used in the treatment of pelvic organ prolapse. The use of synthetic meshes for this condition represents one of the fastest growing segments of the women’s health market. NovaSilk is soft and lightweight and is composed of a knitted, monofilament polypropylene. Although it is Mentor’s first synthetic mesh product for pelvic organ prolapse, the company also markets its human tissue-based Axis and Suspend products for the same disorder. The NovaSilk can be used for a variety of pelvic floor procedures, including cystocele, enterocele, rectocele and vaginal vault prolapse procedures.

Imaging

Hologic Acquires Suros, R2

Hologic will acquire Suros Surgical Systems for $240 million. Hologic is a manufacturer of medical imaging equipment used for detecting breast cancer and osteoporosis. Suros is an interventional medical device manufacturer of minimally invasive surgical platform technology for biopsy tissue removal and biopsy site marking products. Specifically, Suros is a pioneer and leader in MRI-guided breast biopsy technology and vacuum-assisted breast biopsy. The acquisition allows Hologic to strengthen its capabilities within women’s health care. The transaction, which is subject to final approval by Suros’ shareholders and regulatory clearances, is expected to close by the end of June.

In a separate transaction, Hologic has agreed to acquire R2 Technology, which specializes in computer-aided detection (CAD), for $220 million. R2 Technology pioneered the use of CAD for mammography in 1998 when the ImageChecker system became the first CAD system approved by the FDA for screening mammography. The ImageChecker CAD system was also the first system approved for use with digital mammography. R2 has over 2,500 mammography CAD installations worldwide and it posted revenue of about $45 million in calendar 2005. This transaction, which is also subject to shareholder and regulatory approvals, is expected to close in the next few months.

Nanotechnology

Nano Interface Signs Contracts to Develop Biomaterials

The Naval Research Laboratory (NRL) and the Virginia Commonwealth University (VCU) have formally evaluated a variety of products manufactured by Nano Interface Technology. The products consist of biomaterials for coating orthopedic and dental implants. Specifically, Nano Interface has signed a Corporate Research and Development Agreement (CRADA) with NRL related to coatings for orthopedic implants. The collaboration with VCU involves dental applications. Nano Interface has introduced products based on ultra-pure nano-biomaterials for medical devices, such as hip, knee and dental implants.

Nanogen Issued Two Biomarker Patents

The U.S. Patent and Trademark Office has issued Nanogen two patents related to disease biomarkers. One patent claims use of immune system modulation to remove proteins associated with Alzheimer’s disease. The other relates to the isolation and use of a biomarker to diagnose metabolic syndrome, a collection of symptoms including abdominal obesity and high cholesterol associated with the development of diabetes and cardiac disease. These intellectual property assets may be leveraged by Nanogen to develop advanced diagnostic products and could be licensed by potential pharmaceutical partners.

Neurology

Medtronic Gets CE Mark for Exponent RX Carotid Stent

Medtronic has received CE Mark approval for its next-generation self-expanding carotid stent and filter system, offering a new, minimally invasive treatment option to surgical procedures for the prevention of stroke. Called the Exponent RX self-expanding carotid stent, the device is a tiny metal scaffold used to prop open a blocked artery and restore adequate blood flow. While not yet approved for use in the United States, the Exponent is part of the company’s Carotid Solution line, which also includes the Interceptor Plus carotid filter system. The filter is a miniature mesh basket that allows blood to flow normally while it traps loose particles in the bloodstream, thus preventing them from reaching the brain. Medtronic will immediately begin marketing the system in Europe and some international markets.

Oncology

Sicel Technologies’ Implantable Radiation Sensor Gets Clearance

The FDA has granted 510(k) clearance to Sicel Technologies for its wireless, implantable radiation sensor and reader, called DVS (Dose Verification System). The approval was granted based upon successful completion of a multi-center clinical study of breast cancer patients, most of whom were implanted with two DVS sensors prior to receiving radiation treatment. The device is designed so that by using the handheld reader, physicians can determine the actual dose of radiation being delivered to the tumor after each course of therapy.

Orthopedics

Medtronic Sues Kyphon for Patent Infringement

Medtronic’s vascular and spinal divisions have filed a lawsuit against Kyphon for patent infringement, claiming that Kyphon has been directly infringing on a minimum of four patents related to balloon dilation catheters and spinal disc spacing treatment. The lawsuit also seeks a judgment that five Kyphon patents are inapplicable to Medtronic’s new osteotome device, called Equestra, which treats spinal disorders without the use of a balloon. Kyphon has stated that there is no basis for this judgment because it has not threatened to sue Medtronic regarding these patents. Some analysts predict that Kyphon will countersue Medtronic for patent infringement once Medtronic launches its product.

At the same time, Kyphon has expanded its intellectual property coverage over kyphoplasty with the issuance of a method patent that covers various aspects of performing the procedure. This patent, which is not expected to expire until 2014, allows for a method of inserting an expandable device into the vertebrae, which in turn will selectively compact a region of cancellous bone and then fill the compacted region.

St. Francis Technologies Introduces Spinal X Stop Implant

St. Francis Medical Technologies launched its patented X Stop Interspinous Process Decompression (IPD) system at the American Association of Neurological Surgeons 2006 annual meeting last month. Designed to treat lumbar spinal stenosis (LSS), the X Stop is used as a minimally invasive, lower-risk surgical alternative to relieve symptoms. The X Stop is a titanium alloy implant and is the first and only FDA-approved, nonfusion treatment proven to treat symptoms and improve physical function for patients with LSS. Since it was approved by the FDA last November, St. Francis has trained more than 500 spine surgeons around the country in the X Stop procedure. Inserted through a small incision, the X Stop is placed between two bones, called spinous processes of the symptomatic discs in the lower back. The X Stop limits extension of the lumbar spine and keeps open the canal in the lower spine that carries nerves to the legs.

SpineMark Acquires Majority Ownership of Texas Back Institute

SpineMark has acquired 51% of the Texas Back Institute Clinical Research Organization (TBI-CRO), a group that has been involved in more than 50 spine research studies and has worked with more than 20 medical device and pharmaceutical manufacturers. The new organization, SpineMark CRO at TBI, will serve as the flagship research site for the more than 30 SpineMark CROs across the country. SpineMark CRO at TBI will work with biological, medical device and pharmaceutical companies as a hybrid organization to network clinical trials, data warehouse reporting, clinical and financial reporting, and spinal provider sites. It also plans to supervise clinical trials, research studies and education programs for physician groups.

Vascular Surgery

Sciton Introduces Pro-V Laser for Treating Varicose Veins

Sciton introduced its Pro-V 1319 nm Nd:Yag laser for endovenous ablation of the great saphenous vein for the treatment of varicose veins at the International Vein Congress (IVC) in Miami last month. In a 30-patient study of the Pro-V, treatment was successful with no flow at day two. One of the benefits of the Pro-V is the ability to upgrade the system to a complete vein treatment center, including a broadband light source for vascular conditions such as telangiectasia and rosacea. In 2007, Sciton will also introduce the ClearScan 1064nm Nd:Yag for the transcutaneous treatment of spider veins.

FDA Approves Atrium’s FLIXENE Vascular Graft

The FDA has granted 510(k) marketing clearance for Atrium Medical’s FLIXENE, a new vascular product indicated for vascular access and arterial vascular reconstruction. FLIXENE incorporates a biomaterial film lamination process and provides kink and compression resistance for improved surgical handling and minimal needle hole bleeding. The strength of the product minimizes “weeping,” which is often seen with traditional vascular bypass grafts following implantation.

Boston Scientific Launches Vasoview Vessel Harvester

Boston Scientific has introduced in the United States the Vasoview 7 endoscopic vessel harvesting system and Vasoview HemoPro endoscopic vessel harvesting system, two technologies that were developed by Guidant. Boston Scientific acquired Guidant last month. Endoscopic vessel harvesting (EVH) allows removal of a vein from the leg or an artery from the arm through one small incision. EVH has been shown to reduce postoperative pain, recovery time, infection rates and scarring.

Wound Care

Avecia Forms Bio-Processing Partnership for Tissue Engineering

Avecia has formed a three-year partnership with the Centre for Stem Cell Discovery & Regenerative Medicine at the United Kingdom’s Durham University, the Blond McIndoe Centre (experts in plastic and reconstructive surgery), Smith & Nephew, and the Centre for Excellence for Life Sciences to establish bio-processing technology for advanced tissue engineering. The project has received half its funding from the U.K. Department of Trade & Industry with the remaining balance of funding coming from Avecia. The researchers are specifically studying tissue engineering as it applies to wound healing technology, which uses adult skin stem cells to grow sheets of skin that can be grafted onto wounded areas.

Links:
Atrium Medical (Hudson, NH; http://www.atriummed.com)
Avecia (Manchester, U.K.; http://www.avecia.com)
Boston Scientific (Natick, MA; http://www.bostonscientific.com)
CryoCath Technologies (Montreal, Quebec, Canada; http://www.cryocath.com)
Endologix (Irvine, CA; http://www.endologix.com)
ESTECH (San Ramon, CA; http://www.estech.com)
Hologic (Bedford, MA; http://www.hologic.com)
Innocoll (Ashburn, VA; http://www.innocoll.com)
Kyphon (Sunnyvale, CA; http://www.kyphon.com)
Medtronic (Minneapolis, MN; http://www.medtronic.com)
Mentor (Santa Barbara, CA; http://www.mentorcorp.com)
MicroIslet (San Diego, CA; http://www.microislet.com)
Nano Interface Technology (Lorton, VA; http://www.nanointerfacetech.com)
Nanogen (San Diego, CA; http://www.nanogen.com)
R2 Technology (Sunnyvale, CA; http://www.r2tech.com)
Sciton (Palo Alto, CA; http://www.sciton.com)
Shelhigh (Millburn, NJ; http://www.shelhigh.com)
Sicel Technologies (Raleigh, NC; http://www.siceltech.com)
Smith & Nephew (Memphis, TN; http://www.smith-nephew.com)
SpineMark (San Diego, CA; http://www.spinemark.com)
St. Francis Medical Technologies (Alameda, CA; http://www.sfmt.com)
St. Jude Medical (St. Paul, MN; http://www.sjm.com)
Suros Surgical Systems (Indianapolis, IN; http://www.surossurgical.com)